1,964 Directors Of Regulatory Affairs jobs in the United States

Manager, Drug Development Program Management

10591 Tarrytown, New York BioSpace

Posted 8 days ago

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Job Description

Job Details

This position is on-site 4 days per week and 1 day from home. A remote position is not possible for this role.

The Manager Development Program Management provides operational direction as the leader for one or more development programs. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated program plans, goals, budgets, and timelines. The Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers.

In a typical day you will:
  • Support development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development programs, often working under consultative direction.
  • Partner with the Strategic Program Lead to provide operational leadership of program (s) and supports development and execution of overall program strategy by facilitating cross functional Strategic Development Team. Assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Actively aims to strengthen and lead high performance teams.
  • Lead annual goal setting sessions to develop project / program level goals that align with Regeneron's overall goals and monitors progress against these goals.
  • Develop contingency and risk mitigation plans. Oversees the development of integrated project / program plans and actively monitors progress against the approved baselines. Responsible for oversight of the integrated program timeline and budget, including management of variances and escalation where appropriate.
  • Manage the project / program interactions and deliverables between Regeneron and our strategic alliance partners and collaborators (where applicable). Fosters collaborative relationships across the alliance program teams to develop and execute strategic development plans.

This role may be for you if you:
  • Have excellent written, verbal and interpersonal communication skills
  • Can motivate others and build effective teams.
  • Possess strong critical thinking skills.
  • Can make connections and relate details to broader program strategy and goals.
  • Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
  • Are highly organized, and have solid time management skills (both project and self), with ability to manage multiple priorities.

In order to be considered for this opportunity , you must have a BS or MS degree with at least 7+ years of relevant broad project/program management experience required, preferably in the pharmaceutical or related industry and drug development. Specific experience managing the development strategy for a drug candidate is necessary.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)
$113,100.00 - $184,700.00

Company

Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Stock Symbol: REGN

Stock Exchange: NASDAQ

Company info
Website Phone Location Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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Manager, Drug Development Program Management

10591 Tarrytown, New York Regeneron Pharmaceuticals

Posted 8 days ago

Job Viewed

Tap Again To Close

Job Description

This position is on-site 4 days per week and 1 day from home. A remote position is not possible for this role.

The Manager Development Program Management provides operational direction as the leader for one or more development programs. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated program plans, goals, budgets, and timelines. The Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers.

In a typical day you will:

* Support development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development programs, often working under consultative direction.
* Partner with the Strategic Program Lead to provide operational leadership of program (s) and supports development and execution of overall program strategy by facilitating cross functional Strategic Development Team. Assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Actively aims to strengthen and lead high performance teams.
* Lead annual goal setting sessions to develop project / program level goals that align with Regeneron's overall goals and monitors progress against these goals.
* Develop contingency and risk mitigation plans. Oversees the development of integrated project / program plans and actively monitors progress against the approved baselines. Responsible for oversight of the integrated program timeline and budget, including management of variances and escalation where appropriate.
* Manage the project / program interactions and deliverables between Regeneron and our strategic alliance partners and collaborators (where applicable). Fosters collaborative relationships across the alliance program teams to develop and execute strategic development plans.

This role may be for you if you:

* Have excellent written, verbal and interpersonal communication skills
* Can motivate others and build effective teams.
* Possess strong critical thinking skills.
* Can make connections and relate details to broader program strategy and goals.
* Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
* Are highly organized, and have solid time management skills (both project and self), with ability to manage multiple priorities.

In order to be considered for this opportunity, you must have a BS or MS degree with at least 7+ years of relevant broad project/program management experience required, preferably in the pharmaceutical or related industry and drug development. Specific experience managing the development strategy for a drug candidate is necessary.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$113,100.00 - $184,700.00
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Manager, Drug Development Program Management

48088 Warren, Michigan Regeneron Pharmaceuticals

Posted 8 days ago

Job Viewed

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Job Description

This position is on-site 4 days per week and 1 day from home. A remote position is not possible for this role.

The Manager Development Program Management provides operational direction as the leader for one or more development programs. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated program plans, goals, budgets, and timelines. The Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers.

In a typical day you will:

* Support development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development programs, often working under consultative direction.
* Partner with the Strategic Program Lead to provide operational leadership of program (s) and supports development and execution of overall program strategy by facilitating cross functional Strategic Development Team. Assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Actively aims to strengthen and lead high performance teams.
* Lead annual goal setting sessions to develop project / program level goals that align with Regeneron's overall goals and monitors progress against these goals.
* Develop contingency and risk mitigation plans. Oversees the development of integrated project / program plans and actively monitors progress against the approved baselines. Responsible for oversight of the integrated program timeline and budget, including management of variances and escalation where appropriate.
* Manage the project / program interactions and deliverables between Regeneron and our strategic alliance partners and collaborators (where applicable). Fosters collaborative relationships across the alliance program teams to develop and execute strategic development plans.

This role may be for you if you:

* Have excellent written, verbal and interpersonal communication skills
* Can motivate others and build effective teams.
* Possess strong critical thinking skills.
* Can make connections and relate details to broader program strategy and goals.
* Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
* Are highly organized, and have solid time management skills (both project and self), with ability to manage multiple priorities.

In order to be considered for this opportunity, you must have a BS or MS degree with at least 7+ years of relevant broad project/program management experience required, preferably in the pharmaceutical or related industry and drug development. Specific experience managing the development strategy for a drug candidate is necessary.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$113,100.00 - $184,700.00
View Now

Manager, Drug Development Program Management

10591 Tarrytown, New York Regeneron Pharmaceuticals

Posted today

Job Viewed

Tap Again To Close

Job Description

This position is on-site 4 days per week and 1 day from home. A remote position is not possible for this role.
**The Manager Development Program Management** provides operational direction as the leader for one or more development programs. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated program plans, goals, budgets, and timelines. The Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers.
**In a typical day you will:**
+ Support development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development programs, often working under consultative direction.
+ Partner with the Strategic Program Lead to provide operational leadership of program (s) and supports development and execution of overall program strategy by facilitating cross functional Strategic Development Team. Assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Actively aims to strengthen and lead high performance teams.
+ Lead annual goal setting sessions to develop project / program level goals that align with Regeneron's overall goals and monitors progress against these goals.
+ Develop contingency and risk mitigation plans. Oversees the development of integrated project / program plans and actively monitors progress against the approved baselines. Responsible for oversight of the integrated program timeline and budget, including management of variances and escalation where appropriate.
+ Manage the project / program interactions and deliverables between Regeneron and our strategic alliance partners and collaborators (where applicable). Fosters collaborative relationships across the alliance program teams to develop and execute strategic development plans.
**This role may be for you if you:**
+ Have excellent written, verbal and interpersonal communication skills
+ Can motivate others and build effective teams.
+ Possess strong critical thinking skills.
+ Can make connections and relate details to broader program strategy and goals.
+ Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
+ Are highly organized, and have solid time management skills (both project and self), with ability to manage multiple priorities.
**In order to be considered for this opportunity** , you must have a BS or MS degree with at least 7+ years of relevant broad project/program management experience required, preferably in the pharmaceutical or related industry and drug development. Specific experience managing the development strategy for a drug candidate is necessary.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$113,100.00 - $184,700.00
View Now

Director Drug Development Program Management

10591 Tarrytown, New York Regeneron Pharmaceuticals

Posted today

Job Viewed

Tap Again To Close

Job Description

_This position is on-site in Tarrytown, NY 4 days a week and 1 day from home. A fully remote role is not possible for this position._
Using extensive program management knowledge and experience in the drug development industry, the **Director, Development Program Management** provides operational leadership, direction and support to a team, program or project of moderate to large scope, (within a given Therapeutic Area) as well as to the DPM department as a whole. The Director, Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated (project) program plans, goals, budgets, and timelines. Director, Development Program Management is responsible for the successful operation of activities of major significance to the organization.
**In a typical day you will:**
+ Provide operational leadership, direction and support of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial.
+ Independently lead multiple or complex development programs.
+ Partner with the Strategic Program Lead to provide operational leadership of program(s) and supports development and execution of overall program strategy by facilitating cross-functional Strategic Development Team. Independently assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Strengthens and leads high performance teams.
+ Leverage significant project management experience and knowledge of the drug development process, drives team alignment in creation of integrated project / program plans, timelines and budgets. Ensures efficient delivery of plans. Directs annual program goal setting in alignment with Regeneron's overall goals and monitors progress against these goals. Champions potential program risks and ensures contingency plans are in place.
+ Act as a key liaison between Regeneron and our strategic alliance partners and collaborators (where applicable). Prepares, provides input, and / or manages the process involving major presentations for collaboration meetings effecting key business decisions. Responsible for facilitating and driving decision making in support of the joint strategic objectives of the program.
+ **Communication:** Ensures effective, accurate, and timely scientific / technical program-related communication to the team and Sr. Management. Adept at tailoring communications based on audience, effectively framing and communicating nuanced context for stakeholders and capturing rationale for decisions.
**This role may be for you if you:**
+ Have excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company in order to establish credibility with professionals on the project teams.
+ Understand and motivate others and build effective teams.
+ Have strong presentation and critical thinking skills.
+ Actively promote constructive interactions among team members in order to address difficult situations.
+ Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
+ Handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
+ Thrive in fast paced organizations; expert in dealing with ambiguity and uncertainty
**In order to be considered qualified** , you must have a Bachelor's degree and 12+ years of in-house pharmaceutical program management with knowledge of the drug development process as well as understanding of clinical trials.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$180,400.00 - $300,700.00
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Senior Formulation Scientist, Drug Development

78701 Austin, Texas $160000 Annually WhatJobs

Posted 2 days ago

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Job Description

full-time
Our client is a cutting-edge pharmaceutical company dedicated to advancing human health and is seeking an exceptional Senior Formulation Scientist to join our fully remote drug development team. This is a unique opportunity to contribute to the design, development, and optimization of novel drug formulations from the comfort of your home office. You will play a critical role in translating scientific discoveries into viable therapeutic products, working with a team of world-class researchers and developers.

Responsibilities:
  • Design and execute studies for the formulation development of small molecules, biologics, or other therapeutic modalities.
  • Develop robust and scalable manufacturing processes for various dosage forms (e.g., oral solids, injectables, topical).
  • Characterize formulations using a range of analytical techniques (e.g., HPLC, GC, dissolution testing, physical property measurements).
  • Troubleshoot formulation and process-related issues, implementing effective solutions.
  • Conduct pre-formulation studies to assess drug substance properties and guide formulation strategy.
  • Write comprehensive development reports, protocols, and regulatory submission documents.
  • Collaborate closely with cross-functional teams, including analytical development, CMC, process engineering, and regulatory affairs.
  • Stay abreast of emerging technologies and trends in pharmaceutical formulation and drug delivery.
  • Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
  • Mentor junior scientists and contribute to a collaborative and innovative research environment.
  • Manage external research collaborations and vendor relationships as needed.
  • Present scientific findings at internal meetings and potentially at external conferences.
Qualifications:
  • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field.
  • Minimum of 5 years of progressive experience in pharmaceutical formulation development.
  • Proven track record in developing various dosage forms and optimizing drug delivery systems.
  • Hands-on experience with a wide array of formulation development techniques and analytical methods.
  • Strong understanding of CMC principles and regulatory requirements for drug development.
  • Excellent problem-solving, critical-thinking, and experimental design skills.
  • Proficiency in scientific writing and documentation.
  • Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a distributed team setting.
  • Experience with small molecules and/or biologics is desirable.
  • Familiarity with QbD (Quality by Design) principles.
This remote position offers the chance to work on impactful drug development projects and contribute to life-changing therapies. If you are a highly skilled and motivated formulation scientist seeking a challenging remote role, we encourage you to apply.
Apply Now

IAMI Drug Development Research Project Director

66045 Lawrence, Kansas University of Kansas Medical Center

Posted 5 days ago

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Job Description

IAMI Drug Development Research Project Director

The Drug Development Research Project Director position is responsible for developing and implementing Drug Discovery and Early Drug Development project plans on individual projects as well as directing research programs. This position reports directly to the Director of the Institute for Advancing Medical Innovation (IAMI). This position will be located on both Lawrence and Kansas City Medical Center (KUMC) campuses.

Key roles and responsibilities include:

  • Assembling Drug Discovery and Early Development project teams comprised of researchers from KU, Children's Mercy Hospital, Stowers Institute for Medical Research, and collaborators outside the University of Kansas (other universities, contract drug development organizations) to implement project plans from target identification and validation through clinical proof of concept, maintaining a cohesive and highly effective project team during all phases of the drug project.
  • Serving as the primary point of contact for the team and ensuring that open lines of communication are established and maintained throughout the project lifecycle.
  • Playing a leadership role in implementing the strategic plan for KU Drug Discovery integrating functions such as Medicinal Chemistry, Combinatorial Chemistry, High Throughput Screening, Imaging, the Product Development Core, and Animal Resources.
  • Working directly with the Technology Transfer offices on both Lawrence and Kansas City campuses, technology transfer offices at consortium partner institutions, and our private sector partner, BioNovus Innovations, LLC, in support of intellectual property and commercialization activities.
  • Working closely with KUMC School of Medicine, KU Cancer Center, and BioNovus finance associates to secure funding for projects as well as execute projects to meet budget forecasts.
  • Managing broad-reaching research programs. Examples may include providing project and portfolio management support for KU Cancer Center-supported shared resources (e.g., Lead Development and Optimization Shared Resource, Clinical Pharmacology Shared Resource), strategic planning initiatives, public-private partnerships, P01 and SPORE initiatives, as well as development of competencies and capabilities aimed at expanding research portfolios.

In addition to demonstrated expertise in Drug Discovery or Drug Development, this position must demonstrate project management competencies. These competencies include:

  • Understanding project goals and managing project strategy to achieve those goals.
  • Leading the performance of the project tasks per the agreed upon scope of work.
  • Acting as a focal point for all internal and external project communication.
  • Scheduling, monitoring, and communicating the status of the project tasks to the project team.
  • Conducting project team meetings.
  • Generating and distributing concise meeting minutes, action items, and status reports.
  • Preparing the overall project and communication plan with the assistance of the project team.
  • Monitoring the compliance to the project plan and updating the plan as needed.
  • Ensuring the project team members are focused on a common set of objectives.
  • Ensuring that the project objectives and deliverables have been met on time.

The Drug Development Research Project Director will work with either the Drug Discovery, Delivery, and Experimental Therapeutic (D3ET) or Investigator Initiated Trials (IIT) steering committees to advance new cancer therapeutic strategies.

The Drug Development Research Project Director will have responsibilities for supporting KUCC shared resources. This position will work with the Cancer Center Lead Development and Optimization (LDOSR) and Clinical Pharmacology (CPSR) Shared Resource Directors and respective team members to organize, manage, and advance cancer researcher's projects from the laboratory bench to the patient's bedside.

  • For LDOSR, this includes coordination and integration of research activities conducted within the High Throughput Screening (HTS), Medicinal Chemistry (MDCM), and Biotechnology Innovation and Optimization Center (BIOC) cores. Resource activities that are coordinated and monitored for the team include: target selection, development and validation of HTS methods (cell or biochemical based), primary and secondary compound screening, hit compound selection/confirmation/prioritization, structure-activity and structure-property optimization, lead optimization, hit-to-probe, probe-to-lead and lead-to-preclinical candidate progression synthesis chemistry, novel drug delivery, bioanalytical method development, and in vivo pharmacokinetics.
  • For the Clinical Pharmacology Shared Resource, coordination and integration of research activities conducted in support of early phase clinical trials utilizing resources within the Correlative Laboratory, Bioanalytical Chemistry, and Clinical Pharmacokinetics/Pharmacodynamics Cores.

The Drug Development Research Project Director will provide project and portfolio management support to strategic partnerships with industry, academia, government, and disease philanthropy collaborators. Responsibilities will include development of methods and processes that enable, facilitate, and advance collaborative projects with external partners focused on therapeutic, diagnostic, and medical device technologies, coordination of internal and external research activities necessary to create and advance these technologies, as well as pursuit of philanthropic, government, and private sector funding for projects.

Required qualifications include:

  • MSc degree in pharmacology, toxicology, drug metabolism, pharmacokinetics, pharmaceutics, analytical chemistry, or related field(s). Education may be substituted for experience on a year for year basis.
  • 15 years direct work experience in the pharmaceutical industry, specifically experience working in drug discovery or drug development environments.

Preferred qualifications include:

  • MSc or PhD in pharmacology, toxicology, drug metabolism, pharmacokinetics, pharmaceutics, analytical chemistry, or related field(s). Education may be substituted for experience on a year for year basis.
  • Project Management Professional (PMP)
  • Experience managing several projects at once
  • Proficiencies in MS Office suite products, project information archival and sharing platforms such as DropBox and/or Box, and project planning tools such as MS Project

Skills include:

  • Written and verbal communication skills.
  • Organization skills

Required documents include:

  • Resume
  • Cover Letter

If selected as a final candidate for this position, you may be required to complete the Association of American Universities Representations and Warranties document and sign a release of records that will allow the University of Kansas Medical Center to conduct a further background check with former employers. A copy of the Representations and Warranties document can be found here.

Comprehensive benefits package includes:

  • Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
  • Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
  • Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
  • A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.

Compensation statement:

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.

Pay range: $111,000.00 - $83,000.00

Minimum: 111,000.00

Midpoint: 147,000.00

Maximum: 183,000.00

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Research Regulatory Associate, Early Drug development

10261 New York, New York Vets Hired

Posted 8 days ago

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About the job Research Regulatory Associate, Early Drug development

Role Overview:

We are seeking a dynamic clinical research professional to join the Early Drug Development service, supporting the phase 1 research team. The Research Regulatory Associate will be responsible for regulatory management tasks, ensuring that all regulatory documents and files are up-to-date and MSK is always audit-ready. The associate will also develop, revise, and maintain protocol tools to ensure the accurate conduct of clinical research and participate in special projects and task forces as needed.

Responsibilities:

  • Manage the regulatory aspects of research protocols, ensuring accuracy and compliance.
  • Keep regulatory documents and files up to date to ensure audit readiness.
  • Develop, revise, and maintain accurate protocol tools to support the accurate conduct of clinical research.
  • Participate in special projects and task forces as required.
Key Qualifications:
  • 2-4 years of experience in Clinical Research or Regulatory affairs.
Core Skills:
  • Extensive knowledge of regulations related to human subject protection (including 21 CFR and 45 CFR 46) and the Health Insurance Portability and Accountability Act (HIPAA).
  • Strong attention to detail and analytical skills.
  • Ability to plan and prioritize tasks to align with organizational goals.
  • Critical thinking and problem-solving skills to handle unforeseen issues efficiently.
  • Excellent communication skills, with the ability to engage professionally across all levels.
  • Enthusiasm and dedication to the organizations vision, mission, and values.
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Food Service Worker - Labcorp Drug Development

46202 Indianapolis, Indiana ARAMARK

Posted 5 days ago

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**Job Description**
The Food Service Worker will assist the manager with food/meal preparation; maintain cash receipts and meal records. Assist manager in completing daily reports. Maintain high standards of quality in food production, sanitation, and kitchen safety practices.
**Job Responsibilities**
+ Prepare quality food and baked goods according to a planned menu
+ Prepare a daily report that verifies transactions
+ Understand what is inclusive of a meal
+ Ensure storage of food in an accurate and sanitary manner
+ Serve food according to meal schedules, department policies and procedures
+ Use and care of kitchen equipment, especially knives
+ Timely preparation of a variety of food items, beverages, and
+ Add garnishments to ensure customer happiness and eye appeal
+ Coordinate and assist in major cleaning of refrigerators, freezers, and cooking and serving equipment
+ Adhere to all food safety regulations for sanitation, food handling, and storage
+ Adhere to the uniform policy
+ Connect with the Manager daily to understand and accurately prepare menu for the day
+ Supervise the food temperature requirements
+ Maintain a clean and organized work and storage area
+ Scrub and polish counters, clean and sanitize steam tables, and other equipment
+ Follow established procedures and standards for cleanliness, to ensure a balanced and safe environment; duties include sweeping, moping, ware washing
+ Maintain garbage collection site and kitchen floor areas in a neat and sanitary fashion
+ Perform other duties as assigned including other areas in the kitchen
+ This role may have physical demands including, but not limited to, lifting, bending, pushing, pulling and/or extended walking and standing. This role may also require uniforms and/or usage of Personal Protective Equipment (PPE).
At Aramark, developing new skills and doing what it takes to get the job done make a positive impact for our employees and for our customers. In order to meet our commitments, job duties may change or new ones may be assigned without formal notice.
**Qualifications**
+ Food Service Certificate as needed
+ Sufficient education or training to read, write, and follow verbal and written instructions
+ Be able to work quickly and concisely under pressure
**Education**
**About Aramark**
**Our Mission**
Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet.
At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, sex, gender, pregnancy, disability, sexual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law.
**About Aramark**
The people of Aramark proudly serve millions of guests every day through food and facilities in 15 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential. Learn more about working here at or connect with us on Facebook , Instagram and Twitter .
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Remote Senior Data Scientist - Drug Development

84111 Salt Lake City, Utah $140000 Annually WhatJobs

Posted 1 day ago

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Job Description

full-time
Our client is a global leader in pharmaceutical innovation, and they are seeking an exceptional Senior Data Scientist to join their fully remote research and development team. This is a unique opportunity to contribute to critical drug development projects from the comfort of your home office. You will leverage your expertise in statistical modeling, machine learning, and data analytics to extract valuable insights from complex biological and clinical datasets, accelerating the path to new therapies. This remote-first position requires a high degree of self-discipline, proactive communication, and the ability to collaborate effectively with a distributed team across various time zones.

Key Responsibilities:
  • Develop and implement advanced statistical and machine learning models to analyze large-scale R&D data, including genomics, proteomics, clinical trial data, and real-world evidence.
  • Design data-driven strategies to support drug discovery, preclinical development, and clinical trial design and analysis.
  • Identify opportunities to apply AI/ML techniques to solve challenging problems in drug development, such as patient stratification, biomarker discovery, and predictive modeling of drug efficacy and safety.
  • Collaborate with computational biologists, statisticians, and clinical scientists to define data requirements, interpret results, and translate findings into actionable insights.
  • Create compelling data visualizations and dashboards to communicate complex findings to diverse audiences, including senior management and scientific teams.
  • Contribute to the development and maintenance of data infrastructure and best practices for data governance and reproducibility.
  • Stay abreast of the latest advancements in data science, machine learning, and their applications in the pharmaceutical industry.
  • Mentor junior data scientists and contribute to the growth of the data science community within the organization.
  • Proactively engage in virtual team meetings and knowledge-sharing platforms to ensure seamless collaboration.
Qualifications:
  • Master's or Ph.D. in Data Science, Statistics, Computer Science, Bioinformatics, or a related quantitative field.
  • Minimum of 7 years of experience in data science, with a significant portion focused on the pharmaceutical or biotechnology industry.
  • Proficiency in programming languages such as Python or R and associated data science libraries (e.g., scikit-learn, TensorFlow, PyTorch, pandas).
  • Extensive experience with various statistical modeling and machine learning techniques (e.g., regression, classification, clustering, deep learning, survival analysis).
  • Experience handling and analyzing diverse biological datasets (e.g., genomics, transcriptomics, proteomics, clinical data).
  • Familiarity with cloud computing platforms (AWS, Azure, GCP) and big data technologies.
  • Excellent communication and presentation skills, with the ability to explain technical concepts to non-technical stakeholders.
  • Proven ability to work independently, manage projects effectively, and thrive in a remote work environment.
  • Strong problem-solving skills and a passion for applying data to solve complex scientific challenges.
This role offers the flexibility of a fully remote setup, enabling you to contribute to life-changing pharmaceutical research regardless of your physical location.
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