24 Clinical Development Director jobs in Keasbey

• Is a global clinical manager or country / cluster leader responsible for clinical program(s) across indications executing medical strategy for development and marketed products in a defined therapeutic area -Responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring.
• May be responsible for the scientific and medical strategy of assigned sections of a clinical development program.
• Contributes to the development of clinical sections of trial and program level regulatory documents -Contributes to the execution of the section of the clinical program in partnership with global line functions.
• Contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety.
• Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Contributes to medical/scientific training of relevant Novartis stakeholders.
• May serve as speaker for franchise medical/scientific training -Contributes to the global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

• MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred
• 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
• Demonstrated ability to establish effective working relationship with key investigators
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Strong communication skills, written and oral
• Strong interpersonal skills
• Strong negotiation and conflict resolution skills
• Proven ability to work independently or in a cross-functional team setting

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 SUMMARY:

The incumbent will serve as a Clinical Leader in Ophthalmology, Neuroscience, building the Translational Medicine and Early Development Plan and leading the clinical development strategy for early-stage compound(s), in collaboration with Ophthalmology Discovery, Biomarkers, Clinical Development, and other functional partners. This position is accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials and clinical pharmacology studies supporting all phases of development for the ophthalmology portfolio.

ESSENTIAL FUNCTIONS:

• Leading the early development clinical team in the timely completion, content, and quality of key development deliverables including protocols, reports and submissions to health agencies
• Close collaboration with discovery on target identification, biomarker strategies, and NME criteria
• Overseeing active medical and scientific contribution to matrixed cross-functional Early Compound Development Teams and Clinical Teams
• Formulation and implementation of early Clinical Development Plans, including trial design and endpoints · Working with functional partner leadership (e.g., Global Clinical Operations (GCO), Regulatory, Global Medical Safety) to achieve common goals
• Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations
• Participating in formulating our strategy as a key leader in the Ophthalmology Disease Area Stronghold Leadership Team
• Providing key input into due diligence activities for Business Development opportunities
• Collaborating across disease areas and therapeutic areas to optimize the reach of Johnson & Johnson’s differentiated scientific expertise and capabilities
• Participating in cross-departmental or cross-functional projects with broad Johnson & Johnson impact
• Building and maintaining relationships with key opinion leaders
• Provides key input into diligence activities

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Education and Experience: 

• MD (or equivalent) is required.  Board certification in Ophthalmology is preferred

• Detailed and thorough understanding of retinal disorders, including inherited retinal diseases, retinal vascular diseases and degenerative diseases of the macula is required.
• Additional education: Significant academic or pre-clinical research or related experience is especially desirable. Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. Ability to interface effectively with discovery, preclinical, and late clinical development is required. Energy and enthusiasm are essential. Experience working in a Matrix environment is required.
• Excellent oral and written communication and presentation skills are required. The ability to work with cross-functional teams in a matrix environment is required.
• Up to 20% annual travel (domestic and international) may be required.

Required Technical Knowledge and Skills:

• Fluent in written and spoken English
• Working knowledge of the use of Microsoft suite of software products including Excel and Word
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
• Exceptional analytical and critical thinking skills, with the ability to translate complex data (financial/operational) into actionable insights for strategic decision making.
• Exceptional problem-solving skills with the capacity to anticipate risks, to develop creative solutions and to meet objectives.
• Demonstrated ability to develop deep insights (e.g., big picture thinking) based on data analysis and interpretation.
• Results oriented, able to think creatively, critically, and proactively, to drive innovative solutions.
• Breath of experience in leading people of varying levels via coaching and open conversations to reach their full potential, while also providing support and guidance during periods of poor performance.

Special Training or Certification:

• Board certification in Ophthalmology is preferred

The anticipated base pay range for this position is $226,000 to $391,000 USD.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, 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.  For additional general information on Company benefits, please go to: -  Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved acc ommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit no-style="text-align:inherit;">

Clinical Research Nurse (CRN) - Site Network - Oncology - New Jersey

About our Client: We at Barrington James have Partnered with a well established Site Network looking to hire a Clinical Research Nurse (CRN)

Key Responsibilities:

• Deliver competent nursing care to patients and families
• Collaborate with the healthcare team to manage clinic patient flow and address care needs during visits.
• Educate patients and families on Oncological conditions and care.
• Assist providers during procedures such as biopsies, laser treatments, and excisions.

Qualifications and Skills:

• Certified Research Nurse
• Bachelor of Science in Nursing
• 2+ years of Experience

Job Title: Student

Location: East Brunswick (EB)

Department Name: Clinical Research

Req #: 000206366

Status: Hourly

Shift: Day

Pay Range: $0.83 - 20.83 per hour

Pay Transparency:

The above reflects the anticipated hourly wage range for this position if hired to work in New Jersey.

The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience.

Summary

The Childrens Specialized Hospitals Research Internship Program hosts cohorts of undergraduate and graduate students during the Fall, Spring and Summer semesters,

During the internship students

Learn how to analyze research articles and summarize key literature by participating in our Bi Monthly Journal Club,

Establish an understanding of CSHs 5 core areas by engaging in program specific projects,

Based on skillsets and research needs, each intern is paired with an active project or research team that working within our five research areas Autism, Brain Injury, Chronic Health Conditions, Cognition, and Mobility,

Interact with CSH clinical staff and scientific collaborators by conducting clinician interviews, as well as attending local events or clinical team meetings taking place across the RWJBarnabas Health campus,

Responsibilities, duties, and projects

16 hours per week minimum requirement including at least 8 hours on site for 12 weeks

Participation in biweekly journal club

Attendance at weekly meetings with the internship cohort

A staff interview and presentation

A final project, which will be presented during the final weeks of the internship

Completion of work specified by assigned team, may include, data management, data entry, data analysis, literature review, participant recruitment, research engagement activities,

Team specific responsibilities below

Chronic Illness Management Program team

Manage program database in REDCap, including reviewing patient medical records and inputting data

Attend Chronic Illness Management clinic appointments and take notes as applicable

Conduct literature reviews

Other responsibilities not otherwise specified to support program needs

RWJBarnabas Health is an Equal Opportunity Employer

Job Title: Clinical Research Director Location : Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Dermatology, incorporate new methodologies and pro-actively Progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. GD-SA LI-SA LI-Onsite vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information canbe found here.

• Screens, evaluates and enrolls participants for clinical research trails
• Coordinates and schedules clinical assessments, protocol procedures and participant visits
• Serves as main contact for study participants: educates participants and schedules trail procedures
• Holds weekly meetings with PI and study team regarding progress of study
• Creates and maintains source documents, data collection tools, databases and participant files
• Collects and enters data for research projects, ensures accuracy and quality of data
• Secures, processes and delivers and ships clinical specimens
• Serves as main liaison for the study team, study sponsor, applicable regulatory agencies and facility Research Department leadership
• Prepares posters and aids in manuscript and presentation preparation for publications and conferences

• Developments materials and tools for study conduct
• Trains study team on protocol and regulatory procedures; responsible for ensuring protocol adherence
• Responsible for cultivating and maintaining inter-departmental relationships to facilitate research trail conduct and regulatory compliance
• Responsible for tracking inventory of laboratory kits and protocol site materials
• Prepares and submits amendments and annual continuing reviews for IRB and NYC H+H review for established and assigned clinical trails

• Ensures that all appropriate institutional, state and federal regulations are followed throughout the trail
• Maintains documentation and submission of all regulatory requirements for clinical trails at the facility
• Prepares for regulatory agency and sponsor site visits

• Director of Research
• Associate Director of Research
• FRRC Chair
• Members of the Kings County Research Committee
• BRANY, Affiliate and Centralized IRB's

• Bachelor Degree
• Masters in science or healthcare concentration if no previous clinical research or administrative experience
• At least 2 years requisite administrative experience within a healthcare setting
• Up to 1 year clinical research experience a plus

• Competitive compensation package

• 10% 401K company contribution after one year of service, with 3% company contribution starting day one

• Choice of a three tiered, starting at nearly FREE medical plans starting day one

• Excellent dental insurance, including orthodontics coverage starting day one

• Generous paid time off program, sick time and holidays

• Salary: $57,387.20

WHY VITALIEF?

Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape.  By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.   

We are seeking a talented and enthusiastic Oncology Clinical Research Nurse to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives.  This is an excellent opportunity for an Oncology experienced Nurse that is interested in transitioning into a rewarding career in the clinical research profession.

Reasons to work for Vitalief:

• You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.

• Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.

• We give everyone a seat at the table – we encourage innovation.

• Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.

• Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.

Salary Range:  Market competitive - based on experience level.

Work Location:  Work is 5 days per week on-site in New Brunswick, NJ. At the 4-month mark (after the training period), resource can work one day per week remotely.

Responsibilities:

• Under the direction of the Clinical Research Study Site Leader, this resource will be responsible for supporting mostly Medical Oncology interventional studies (phase I through phase III) - Solid Tumor, Lung, Head and Neck, Melanoma and Neurology.  Studies are mostly drug and Biologic (very few device studies).  Studies often involve radiation and surgery.

• Proactively manages, coordinates, and delivers high-quality, compassionate hands-on competent oncology nursing care and coordinates with the assigned clinical team, investigators, and ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) as per protocol requirements and ensures adherence to the treatment plan and Good Clinical Practice (GCP) guidelines.

• Assist investigators (physicians) to prepare and implement new clinical trials, screens and enrolls study participants, and provides protocol-related clinical management to those participants while on study.

• This is NOT a typical nursing role that is task-based, and tasks dictated by physicians. The Nurse has to be a critical thinker, to prioritize, and be “appropriately assertive” and comfortable pushing back on physicians to “save them from themselves” – looking at study protocol and see are orders all correct as it relates to medical record, is anything missing, does the patient have what they need?

• The role will follow group assignments.  The Physicians have designated clinic days.  These are the days the Nurses will see more patients.  On non-clinic days, the Nurse will see less patients and perform administrative tasks including patient documentation, patient phone calls, making sure orders are correct (ensuring nothing is missing) and perform project management related activities.

• Collaborate with Protocol Activation office to initiate and activate all new clinical trial protocols assigned utilizing Oncore Study-start up task list.

• Reviews patient’s charts and medical history to confirm protocol eligibility and obtains source documents (i.e., medical record documentation) as needed.

• Demonstrate basic knowledge to accomplish core tasks such as recording and reporting Serious Adverse Events (SAE) in a timely manner, accessing protocol attachments via OnCore™, enter charts into Medical Records Database, formatting, and printing patient study calendars, etc.

Required Skills:

• Graduate from an accredited school of nursing with a license to practice in the State of New Jersey.

• Bachelor of Science in Nursing (BSN) Degree.

• 2 or more years of nursing experience working in a hospital setting.

• 1 or more years of experience working in an Oncology specialty area in a hospital or clinic setting.

• Experience working in a clinical research/trial participant facing role is a big plus (but this is not a requirement – resource will be trained in clinical research).

• Must be a critical thinker, prioritize, and be “appropriately assertive” and comfortable pushing back on physicians stressing the importance of accurate patient information relative to the study protocol.

• Communication Skills: The Nurse is the point person for communication with other departments.  Able to communicate and articulate, translate complicated information back to a patient in a way they can understand (very important part of this job).

• Document Management Skills:  comfortable editing in Microsoft Word, basic reporting in Excel, converting PDFs or Word Documents in Adobe.  Comfortable with PowerPoint to provide education with other Nurses. MS Office, Teams, and SharePoint.

• Detail oriented but not to the point of stagnation. 

• Must be able to thrive in a fast-paced, Academic, diverse environment.

• Must be proactive - it’s a learning environment, where Nurses are encouraged to ask questions.

• Proficient in computer applications (i.e., Microsoft Word & Excel, OnCore™ or other Clinical Trial Management Systems, medical records database systems, etc.).

PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.

IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

#LI-DNI

Powered by JazzHR

Ideally would like to see an Associates degree or higher. But willing to work with years of experience. Oncology experience is a PLUS. Job Description: As an Oncology Clinical Research Coordinator (CRC), you will be an integral part of studies at the clients by recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position. Responsibilities Include: Provide overall coordination of study-related activities for patients enrolled in cancer research studies through the clients research program. Coordinate with Principal Investigators, Supervisor and study sponsors and CROs to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of the clients and the sponsors and CROs. Assist in the coordination of tests and visits for patients and collaborate with the clients study team to maximize work efficiency and productivity. Assist in IRB submissions and interact with the Supervisor to maintain regulatory documents and administrative files for each protocol. Work with research nurses, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials. Maintain patient and regulatory research records. Confer with all members of the clinical team to confirm appropriateness and timeliness of tests. Collect follow-up data on patient's post-treatment as required by the protocol. Submit weekly reports to Supervisor, tracking patient screening/enrollment and subject status. Enter research data into a centralized database as per protocol requirements. Attend investigator meetings as required or requested by the Principal Investigator. Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs. If applicable, able to prepare blinded and unblinded study drugs. If applicable, act as primary coordinators for unblinded team

Job DescriptionResponsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.Essential Duties And ResponsibilitiesParticipate and assist in design and preparation of protocols and case report forms.Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.Participate in the evaluation of potential clinical sites according to established criteria of acceptability.Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.Assist with the maintenance of clinical archive and electronic files.Other tasks as assigned.RequirementsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.BA, BS, RN, BSN or equivalentBasic knowledge and adherence to GCPs5+ years of clinical research experienceStrong attention to detailAbility to multi-taskUnquestionable integrity and highest ethical standardsExcellent written and verbal communication skillsSelf-motivated, assertive, and driven