340 Clinical Development jobs in the United States

Our client, a prestigious pharmaceutical company renowned for its groundbreaking research, is looking for an exceptional Clinical Development Scientist to join their innovative team. This role offers a hybrid work model, allowing for a balance of in-office collaboration and remote flexibility. You will play a pivotal role in the design, execution, and interpretation of clinical trials for novel therapeutic agents. This position requires a strong scientific background, a comprehensive understanding of drug development processes, and the ability to translate scientific concepts into effective clinical strategies. The ideal candidate will possess a Ph.D. or M.D. in a relevant scientific discipline and have substantial experience in clinical trial design and management within the pharmaceutical industry. Responsibilities include developing clinical development plans, authoring clinical study protocols and reports, collaborating with internal and external stakeholders (including investigators, CROs, and regulatory agencies), and analyzing clinical data to inform strategic decisions. You will also contribute to the scientific and strategic direction of drug development programs, ensuring alignment with regulatory requirements and commercial objectives. Strong analytical, critical thinking, and communication skills are essential. The ability to work effectively in a cross-functional team environment is paramount. This is a unique opportunity to contribute to the advancement of life-saving medicines and shape the future of pharmaceutical innovation.
Location: New York City, New York, US

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at no-style="text-align:left">Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders.  With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.

Intra-Cellular Therapies, a Johnson & Johnson company, is on the path to be the #1 leader in neuroscience. With an exceptional suite of products and a commitment to transforming patient lives, we are expanding our CAPLYTA® Marketing team to support our growing impact in the marketplace.

Director, Clinical Development, will be responsible for the leadership, oversight, and medical integrity of psychiatry studies/programs. This individual will monitor clinical studies, review and interpret clinical trial data,

provide input into clinical study and regulatory communications and reports, and contribute to clinical development plans and strategy.

Job Responsibilities

• Provide cross functional Clinical Development leadership for internal and external team members in the delivery of clinical studies:

  • Provide a role in the strategic planning of clinical studies and programs, including the development of study design, milestones, key deliverables.

  • Provide support and oversight to all other functional areas of the study teams throughout the lifecycle of the study (startup, maintenance, closeout) in order to ensure data integrity, resolve and/or escalate issues, achieve alignment, and adhere to study goals and timelines.

  • Act as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites and Investigators.

  • Provide medical monitoring, which includes reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management.

  • Work with Biometrics to contribute to the analysis and interpretation of clinical results.

• Author, review, and/or provide strategic input into:

• Clinical sections of regulatory documents including, IND submissions, annual updates, DSUR, investigator brochures, and briefing documents.

• Study specific documents such as study protocols/amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports.

• Scientific publications, manuscripts, posters, or other documents intended for external audiences.

• Represent Clinical Development at Regulatory Authority Meetings.

• Present the clinical development aspects of a project and clinical trial results at internal or external meetings.

• Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan.

• Complete all company and job-related training as assigned within the required timelines.

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

• Duties, responsibilities, and activities may change at any time with or without notice.

Job Requirements

• MD degree or international equivalent

• Active medical license

• Specialty training in Psychiatry

• Minimum 1 -3 year clinical/research experience in the pharmaceutical industry, relevant governmental organizations, or academic research setting required.

• Ability to travel at least 30%

• Ability to work in a team setting as well as function as an individual contributor

• Ability to work efficiently and under tight timelines

• Ability to communicate effectively

• Ability to be flexible in an ever-changing environment

• Ability to think strategically and be able to anticipate problems before they occur

• Ability to be proactive in finding solutions to issues

• Proficient in Microsoft Office (Word, Excel, PowerPoint)

• Must be able to perform all essential functions of the position, with or without reasonable accommodation

The base pay range for this position is $194,000 - $ 334,640 . The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.  Bonuses are awarded at the Company’s discretion on an individual basis.  Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.  Additional information can be found through the link below.

Information on benefits can be viewed by following this link:   & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via .

Internal employees contact AskGS to be directed to your accommodation resource.

About Johnson & Johnson  

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex di seases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at no-style="text-align:inherit">

Job Summary:
Provides educational opportunities to nurses for their professional development by identifying individuals and/or groups who do not meet established competency expectations, conducting needs assessments to identify and bridge knowledge, skill, and/or practice gaps, and designing education programs to meet the learning and developmental needs of the clinical staff. Responsible for effective development delivery by applying adult learning principles and the educational design process to implement development and learning programs and serving as a trainer by leading professional development and using best practices for education modalities. Monitors effectiveness of development by reviewing metrics and outcome measures to ensure education programs meet targets and promote the delivery of high quality health care. Participates in continuous improvement by researching and critically appraising the literature to stay current with advancements in nursing practice, evidence-based guidelines, and health care technology to apply field advancements to the practice setting. Supports clinical development through the use of internal and/or external resources by influencing and collaborating on the goals, objectives, and planned outcomes of professional nursing education programs. Verifies clinical and professional standards are implemented and met by developing, applying, and reviewing policies, protocols, operations, and automated systems providing information to staff and providers.
Essential Responsibilities:
+ Promotes learning in others by proactively providing and/or developing information, resources, advice, and expertise with coworkers and members; builds relationships with cross-functional/external stakeholders and customers. Listens to, seeks, and addresses performance feedback; proactively provides actionable feedback to others and to managers. Pursues self-development; creates and executes plans to capitalize on strengths and develop weaknesses; leads by influencing others through technical explanations and examples and provides options and recommendations. Adopts new responsibilities; adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; champions change and helps others adapt to new tasks and processes. Facilitates team collaboration to support a business outcome.
+ Completes work assignments autonomously and supports business-specific projects by applying expertise in subject area and business knowledge to generate creative solutions; encourages team members to adapt to and follow all procedures and policies. Collaborates cross-functionally and/or externally to achieve effective business decisions; provides recommendations and solves complex problems; escalates high-priority issues or risks, as appropriate; monitors progress and results. Supports the development of work plans to meet business priorities and deadlines; identifies resources to accomplish priorities and deadlines. Identifies, speaks up, and capitalizes on improvement opportunities across teams; uses influence to guide others and engages stakeholders to achieve appropriate solutions.
+ Provides educational opportunities to nurses for their professional development by: identifying individuals and/or groups who do not meet established competency expectations and recommending longitudinal education plans; conducting needs assessments to identify and bridge knowledge, skill, and/or practice gaps; developing and implementing remediation plans in collaboration with key stakeholders and coaching to close gaps in competency expectations, knowledge, skill, and/or practice gaps; designing education programs to meet the learning and developmental needs of the clinical staff, including the creation of study protocols, timelines, and budgets, in alignment with company objectives and regulatory guidelines; creating content (e.g., course curricula, training aids, other supporting materials) in relation to orientation, competency validation, and/or core education for specific nursing care, ensuring curriculum accuracy and providing troubleshooting as needed; and collaborating with subject matter experts, nursing leaders, and other stakeholders to ensure the content and delivery of educational programs meet the needs of the target audience.
+ Verifies certain standards are implemented and met by: monitoring processes to ensure compliance with all legal, regulatory, and accreditation requirements; ensuring that information provided is accurate, consistent, and delivered in alignment with evidence-based practices, institutional policies, procedures, and protocols; and developing, implementing, and reviewing policies, procedures, protocols, operations, and automated systems providing information to staff and providers.
+ Participates in continuous improvement by: researching and critically appraising the literature to stay current with advancements in nursing practice, evidence-based practice guidelines, and health care technology to apply field advancements to the practice setting and ensure educational content remains up-to-date; preparing, conducting, and reviewing ongoing assessments of individual performance in clinical proficiencies for staff and management; and acting as an advocate to ensure continuous learning by linking identified educational needs to current and planned programs offered by internal and external sources and implementing improvements in education programs.
+ Responsible for effective development delivery by: developing and delivering short, intermediate, and long-range education/development plans to meet current and future needs for nursing resources, professional practice, and strategic objectives; applying adult learning principles and the educational design process to implement development and learning programs; and serving as a trainer by leading professional development and using best practices for education modalities (e.g., virtual, in-person classroom).
+ Monitors effectiveness of development by: developing and implementing measures to assess the achievement of education objectives related to patient safety, competency, and professional development requirements; reviewing metrics and outcome measures to ensure education programs meet targets and promote the delivery of high quality health care; facilitating debrief sessions and providing feedback to other trainers based on education assessment; and making necessary revisions to continuously improve program quality.
+ Supports clinical development through the use of internal resources by: influencing and collaborating on the goals, objectives, and planned outcomes of professional nursing education programs; documenting and analyzing clinical workflows to evaluate current practices; providing consultative services to internal and external partners and stakeholders in the areas of professional nursing education program design, development, improvement, and evaluation; and engaging in interdisciplinary committees to integrate educational activities into clinical care.
Minimum Qualifications:
+ Minimum one (1) year of experience in clinical teaching or precepting, nursing professional development, delivering educational programs, curriculum design, process improvement, professional development/evaluation, or related experience.
+ Bachelors degree in Nursing or a health-related field AND minimum three (3) years of experience in an inpatient setting, clinic, and or skilled nursing department or a directly health-related field.
+ This job requires credentials from multiple states. Credentials from the primary work state are required at hire. Additional Credentials from the secondary work state(s) are required post hire.
+ Registered Nurse License (Maryland) within 6 months of hire AND Registered Nurse License (Virginia) within 6 months of hire
OR
+ Compact License: Registered Nurse within 6 months of hire
+ Registered Nurse License (District of Columbia) within 6 months of hire
+ Basic Life Support required at hire
Additional Requirements:
+ Knowledge, Skills, and Abilities (KSAs): Written Communication; Learning Measurement; Business Relationship Management; Consulting; Relationship Building; Program Development; Curriculum Development; Adult Learning Theory; Presentation Skills; Change Management; Content Development; Applied Data Analysis; Model Creation and Interpretation; Knowledge Management; Competency Assessment; Employee Training; Coordination; Key Performance Indicators; Quality Improvement; Clinical Learning Solutions; Nursing Principles
COMPANY: KAISER
TITLE: Clinical Development Nurse II
LOCATION: Hyattsville, Maryland
REQNUMBER:
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.

Job Summary:
Provides educational opportunities to nurses for their professional development by identifying individuals and/or groups who do not meet established competency expectations, conducting needs assessments to identify and bridge knowledge, skill, and/or practice gaps, and designing education programs to meet the learning and developmental needs of the clinical staff. Responsible for effective development delivery by applying adult learning principles and the educational design process to implement development and learning programs and serving as a trainer by leading professional development and using best practices for education modalities. Monitors effectiveness of development by reviewing metrics and outcome measures to ensure education programs meet targets and promote the delivery of high quality health care. Participates in continuous improvement by researching and critically appraising the literature to stay current with advancements in nursing practice, evidence-based guidelines, and health care technology to apply field advancements to the practice setting. Supports clinical development through the use of internal and/or external resources by influencing and collaborating on the goals, objectives, and planned outcomes of professional nursing education programs. Verifies clinical and professional standards are implemented and met by developing, applying, and reviewing policies, protocols, operations, and automated systems providing information to staff and providers.
Essential Responsibilities:
+ Promotes learning in others by proactively providing and/or developing information, resources, advice, and expertise with coworkers and members; builds relationships with cross-functional/external stakeholders and customers. Listens to, seeks, and addresses performance feedback; proactively provides actionable feedback to others and to managers. Pursues self-development; creates and executes plans to capitalize on strengths and develop weaknesses; leads by influencing others through technical explanations and examples and provides options and recommendations. Adopts new responsibilities; adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; champions change and helps others adapt to new tasks and processes. Facilitates team collaboration to support a business outcome.
+ Completes work assignments autonomously and supports business-specific projects by applying expertise in subject area and business knowledge to generate creative solutions; encourages team members to adapt to and follow all procedures and policies. Collaborates cross-functionally and/or externally to achieve effective business decisions; provides recommendations and solves complex problems; escalates high-priority issues or risks, as appropriate; monitors progress and results. Supports the development of work plans to meet business priorities and deadlines; identifies resources to accomplish priorities and deadlines. Identifies, speaks up, and capitalizes on improvement opportunities across teams; uses influence to guide others and engages stakeholders to achieve appropriate solutions.
+ Provides educational opportunities to nurses for their professional development by: identifying individuals and/or groups who do not meet established competency expectations and recommending longitudinal education plans; conducting needs assessments to identify and bridge knowledge, skill, and/or practice gaps; developing and implementing remediation plans in collaboration with key stakeholders and coaching to close gaps in competency expectations, knowledge, skill, and/or practice gaps; designing education programs to meet the learning and developmental needs of the clinical staff, including the creation of study protocols, timelines, and budgets, in alignment with company objectives and regulatory guidelines; creating content (e.g., course curricula, training aids, other supporting materials) in relation to orientation, competency validation, and/or core education for specific nursing care, ensuring curriculum accuracy and providing troubleshooting as needed; and collaborating with subject matter experts, nursing leaders, and other stakeholders to ensure the content and delivery of educational programs meet the needs of the target audience.
+ Verifies certain standards are implemented and met by: monitoring processes to ensure compliance with all legal, regulatory, and accreditation requirements; ensuring that information provided is accurate, consistent, and delivered in alignment with evidence-based practices, institutional policies, procedures, and protocols; and developing, implementing, and reviewing policies, procedures, protocols, operations, and automated systems providing information to staff and providers.
+ Participates in continuous improvement by: researching and critically appraising the literature to stay current with advancements in nursing practice, evidence-based practice guidelines, and health care technology to apply field advancements to the practice setting and ensure educational content remains up-to-date; preparing, conducting, and reviewing ongoing assessments of individual performance in clinical proficiencies for staff and management; and acting as an advocate to ensure continuous learning by linking identified educational needs to current and planned programs offered by internal and external sources and implementing improvements in education programs.
+ Responsible for effective development delivery by: developing and delivering short, intermediate, and long-range education/development plans to meet current and future needs for nursing resources, professional practice, and strategic objectives; applying adult learning principles and the educational design process to implement development and learning programs; and serving as a trainer by leading professional development and using best practices for education modalities (e.g., virtual, in-person classroom).
+ Monitors effectiveness of development by: developing and implementing measures to assess the achievement of education objectives related to patient safety, competency, and professional development requirements; reviewing metrics and outcome measures to ensure education programs meet targets and promote the delivery of high quality health care; facilitating debrief sessions and providing feedback to other trainers based on education assessment; and making necessary revisions to continuously improve program quality.
+ Supports clinical development through the use of internal resources by: influencing and collaborating on the goals, objectives, and planned outcomes of professional nursing education programs; documenting and analyzing clinical workflows to evaluate current practices; providing consultative services to internal and external partners and stakeholders in the areas of professional nursing education program design, development, improvement, and evaluation; and engaging in interdisciplinary committees to integrate educational activities into clinical care.
Minimum Qualifications:
+ Minimum one (1) year of experience in clinical teaching or precepting, nursing professional development, delivering educational programs, curriculum design, process improvement, professional development/evaluation, or related experience.
+ Bachelors degree in Nursing or a health-related field AND minimum four (4) years of experience in an inpatient setting, clinic, and or skilled nursing department or a directly health-related field.
+ Registered Professional Nurse License (Georgia) required at hire
+ Basic Life Support required at hire
Additional Requirements:
+ Knowledge, Skills, and Abilities (KSAs): Written Communication; Learning Measurement; Business Relationship Management; Consulting; Relationship Building; Program Development; Curriculum Development; Adult Learning Theory; Presentation Skills; Change Management; Content Development; Applied Data Analysis; Model Creation and Interpretation; Knowledge Management; Competency Assessment; Employee Training; Coordination; Key Performance Indicators; Quality Improvement; Clinical Learning Solutions; Nursing Principles
COMPANY: KAISER
TITLE: Clinical Development Nurse II
LOCATION: Atlanta, Georgia
REQNUMBER:
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
At Gilead Sciences, we're driven by our mission to discover, develop, and deliver innovative therapeutics that improve the lives of patients worldwide.
Job Description
You will typically lead multiple components of clinical trial programs in immunology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
We will consider levelling this role up to a Director if it aligns with experience.
**This is a site-based role at our global headquarters in Foster City, CA.** We offer a hybrid environment with optional Mondays and Fridays the ability to work from home.
**EXAMPLE RESPONSIBILITIES:**
+ Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
+ Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
+ Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
+ Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
+ Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
+ Coordinates the collection and assimilation of ongoing data for internal analysis and review.
+ Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
+ Presents scientific information at scientific conferences as well as clinical study investigator meetings.
+ Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Minimum Education & Experience**
+ MD or equivalent with 2+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
+ Experience in phase 1 and 2 clinical trials is preferred.
+ Board certification in rheumatology/dermatology/gastroenterology or allergy and immunology is preferred, including familiarity with systemic autoimmune diseases.
+ Experience in the biopharma industry is preferred.
+ Experience leading small cross-functional project teams in clinical research or development.
+ Experience taking the lead on study concept and protocol design, regulatory filings, medical monitoring, clinical publications and presentations is preferred.
+ Proven effectiveness managing clinical project deliverables through matrix management.
**Knowledge & Other Requirements**
+ Demonstrated ability to be a fast learner.
+ Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
The salary range for this position is: $261,375.00 - $338,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
The Director, Clinical Development - Inflammation will lead the design, execution, and oversight of clinical trials in support of Gilead's inflammation portfolio. This individual will play a key role in shaping clinical strategy, collaborating cross-functionally with research, regulatory, safety, and commercial teams to advance innovative therapies that address unmet medical needs in inflammatory diseases.
**Job Responsibilities**
+ Lead the development and execution of clinical trial protocols for inflammation programs, ensuring scientific rigor and regulatory compliance.
+ Serve as the clinical lead on cross-functional study teams, providing medical and strategic input throughout the clinical development lifecycle.
+ Analyze and interpret clinical trial data; contribute to clinical study reports, regulatory submissions, and publications.
+ Collaborate with external experts, investigators, and regulatory authorities to support program objectives.
+ Contribute to the development of long-term clinical strategies and lifecycle management plans.
+ Mentor and develop junior clinical team members, fostering a culture of scientific excellence and collaboration.
+ Represent Clinical Development in internal governance and external scientific forums.
**Basic Qualifications**
+ PhD/ Pharm D and 8 years of experience
OR
+ MD (or equivalent medical degree) and 4 years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
**Preferred Qualifications**
+ · MD or equivalent with board certification or eligibility in a relevant specialty (e.g., rheumatology, immunology, dermatology, or respiratory).
+ · Extensive experience in clinical development within the pharmaceutical or biotechnology industry, ideally in inflammation or immunology.
+ · Proven track record of leading clinical trials from Phase 1 through Phase 3.
+ · Strong understanding of regulatory requirements and clinical trial design.
+ · Excellent communication, leadership, and cross-functional collaboration skills.
+ · Experience interacting with regulatory agencies and external stakeholders.
**People Leader Accountabilities:**
-Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
way they manage their teams.
-Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and
realize their purpose.
-Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $261,375.00 - $338,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
This role supports Allergan Aesthetics, an AbbVie company, where we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more.
With our own research and development team focused on driving innovation in aesthetics, we're committed to providing the most comprehensive science-based product offerings available.
Job Description
The Director I will provide direction and oversight to the design, planning and execution of research activities including but not limited to clinical trials in Aesthetic Medicine. Participate and lead cross-functional teams to generate, deliver and interpret high quality research and clinical data supporting aesthetic indications and overall asset program strategy. As a clinical development subject matter expert, author, edit and review key section of research protocols, reports and regulatory submissions.
Responsibilities:
+ Based on strong medical and scientific experience, knowledge of compliance and regulatory requirements, Allergan Aesthetics customers, markets, business operations and emerging issues , manage the design and implementation of research protocols for clinical development programs in support of the overall Product Development Plan.
+ Oversees project-related education of investigators, study site personnel and AbbVie study staff.
+ Responsible for understanding and addressing applicable regulatory requirements related to the clinical studies, clinician reported outcomes, patient reported outcomes and global drug development. Specifically in the area of aesthetics development.
+ Contributes to design, analysis, interpretation, presentation and reporting of scientific protocols, Investigator Brochures, Clinical Study Reports, Clinician Reported Outcome Dossiers, regulatory submissions and responses and other program documents.
+ Contribute to the development of a rigorous, cross-functionally-aligned, vetted Integrated Evidence Plans in collaboration with matrix team members.
+ Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies.
+ Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
The position is based in Irvine, CA.
Qualifications
+ Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
+ Ability to provide input and direction to clinical research teams with minimal supervision.
+ Strong cross-functional collaboration and leadership skills in a team-matrixed environment.
+ Experience managing program budgets, timelines.
+ Demonstrated ability to select, contract and manage vendor, ensuring high-quality and on time deliverables
+ At least 5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
+ Knowledge of clinical trial methodology, regulatory and compliance requirements in Aesthetic Medicine.
+ Ability to interact externally and internally to support global scientific and business strategy. Must possess excellent oral and written English communication skills.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $200,500 - $82,000
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
+ This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
#LI-AA
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
$1 6,000 - 296,500

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Associate - Clinical Development Sciences

Associate Clinical Development Sciences position providing laboratory support for clinical studies. Execute analytical methods for clinical samples. Assist in the interpretation and recommend changes to scientific protocols and procedures

Your Responsibilities:

• Laboratory Analysis:  Performs analytical methods on clinical samples, including traditional culturing techniques for bacterial and viral targets.

• Laboratory Maintenance:  Maintains a clean, organized, and safe lab environment, including scheduling and performing instrument/equipment maintenance and evaluating new equipment.

• Study Support:  Coordinates with the study execution team to process clinical samples and complete analyses within study timelines.

• Documentation and Data Analysis:  Prepares SOPs/working procedures, performs data analysis, and organizes data for reports.

• Collaboration:  Contributes to troubleshooting, collaborates with colleagues. Follows all relevant internal and external guidelines (SOPs, GxP, HSE, AW) and maintains compliance with quality systems.

What You Need to Succeed (Minimum Qualifications):

• Bachelor’s in biology, microbiology, immunology, animal science or related scientific discipline

What Will Give You the Competitive Edge (Preferred Qualifications):

• Thorough understanding of clinical laboratory study design, execution and operations

• Proven interpersonal skills with demonstrated expertise while working in teams

• Good presentation skills and scientific/technical writing skills

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks:  

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: 

• Multiple relocation packages for eligible roles

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 

• 8-week parental leave 

• 9 Employee Resource Groups 

• Annual bonus offering 

• Up to 6% 401K matching 

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**About the Role:**
The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing comprehensive product training frameworks, and ensuring rigorous adherence to design control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards.
**Core Responsibilities:**
**Device Clinical Strategy & Risk Management:**
+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices
+ Develop comprehensive risk management strategies for devices and combination products including patient harm assessment in Hazard Analysis
+ Support translation of clinical and user needs into technical requirements
+ Coordinate risk mitigation activities across clinical, regulatory, quality, and engineering functions
+ Perform safety reviews on device and combination products from clinical trials and from the field
**Training Development:**
+ Design evidence-based product use training programs for patients, healthcare professionals, and clinical trial staff
+ Develop innovative instructional methodologies aligned with developmentally tailored learning principles
+ Establish metrics to evaluate training effectiveness and implement continuous improvement
**Clinical Quality Assurance & Compliance:**
+ Implement quality management systems for clinical activities related to device development
+ Develop and maintain clinical SOPs and clinical trial related device documentation
+ Support quality audits and implement corrective and preventive actions (CAPAs)
**Clinical Trial Support:**
+ Develop device-specific training materials and review protocols for clinical trials
+ Implement train-the-trainer programs for clinical research sites
+ Provide real-time clinical guidance on device-related aspects during trials
**Design Control Adherence:**
+ Ensure clinical input is incorporated throughout the design control processes
+ Review and approve user requirements, design specifications, and verification/validation plans
+ Maintain traceability between clinical needs and technical specifications
**Human Factors & Usability:**
+ Support use workflow development and usability engineering processes
+ Support formative and summative human factors study training
**Regulatory Engagement:**
+ Support audits from internal teams and Health Authorities related to device clinical development
+ Prepare clinical sections for regulatory submissions (IDE, 510(k), PMA, IND, NDA, BLA)
+ Represent clinical perspectives in regulatory meetings and correspondence
**Vendor Management:**
+ Provide subject matter expertise and mentorship to vendors performing clinical functions
+ Establish vendor oversight frameworks and performance metrics
+ Conduct vendor qualification, selection, and performance evaluation
**Cross-functional Collaboration:**
+ Facilitate seamless integration between clinical functions and device development teams
+ Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs, quality, and commercial functions
+ Coordinate interdepartmental initiatives to optimize device clinical development timelines
**Process Innovation:**
+ Lead initiatives to improve efficiency of clinical development processes
+ Implement data-driven approaches to optimize clinical activities
+ Develop innovative solutions to streamline device clinical development
**Team Leadership & Development:**
+ Promote a culture of scientific excellence, adherence to regulatory and quality standards, and patient-focused innovation.
+ Lead, mentor, and develop organization on device clinical development best practices, strategies, and trends
**Required Qualifications:**
+ An advanced degree in medical, clinical, healthcare science, or a related field:
**Doctorate degree with 7+ years of experience, OR**
**Master's degree with 13+ years of experience, OR**
**Bachelor's degree with 15+ years of experience**
+ Minimum 5 years of combination product, medical device, or pharmaceutical industry experience
+ Experience with both medical devices, drug-device combination products, digital health technologies across multiple therapeutic areas
+ Experience with device design control processes and risk management methodologies
+ Thorough understanding of FDA, EMA, and international regulations for medical devices and combination products
+ Proven ability to thrive in a fast-paced environment supporting multiple development programs
**Preferred Qualifications:**
+ A Health Care Provider (HCP) that is practicing part-time (no more than 5 days per month) is strongly preferred
+ Advanced program management skills
+ Strong background in clinical research methodology
+ Exceptional stakeholder management and conflict resolution capabilities
This role offers an exceptional opportunity to drive innovation at the intersection of medical devices and pharmaceutical development, with significant impact on patient care and treatment outcomes.
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Lexington, MA
**U.S. Base Salary Range:**
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Lexington, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.