Director, Clinical Pharmacology Lead

3 days ago

Boston MA United States Organon & Co. Full time
Organon & Co. Director, Clinical Pharmacology Lead Boston, Massachusetts Apply Now

This position can be 100% remote in the US

The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical development & translational medicine development strategy supporting development assets within the Organon portfolio. The TMED Lead also will be responsible for the rationale, study design and oversight of phase 1 to 2a study protocols, in collaboration with internal (biostatistics, clinical operations) and external (contract research organization (CRO), bioanalytical and/or modeling vendors). The TMED Lead will ensure the scientific and clinical pharmacology components of study protocols are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.

The TMED Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction with the TMED Operations Lead) and reporting thereof.

Responsibilities

  1. Ensure early development plans incorporate a biomarker strategy and leverage PK/PD modeling to establish an exposure-response relationship that optimizes dose selection, facilitates the efficiency of the overall program development plans and enables fastest to market opportunities.
  2. May represent the TMED function or serve as subject matter expert for translational medicine and clinical pharmacology on ADTs responsible for devising and executing on the EDP (TMED scope: first-in-man to Phase 2a), late-stage development plans or, for mature or commercial assets, LCM plans.
  3. Participate in or lead ADT sub-team meetings, as appropriate.
  4. Responsible for the design, execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with the program plans and serve as an active member of the clinical study team.
  5. Provide input to vendor selection and provide vendor oversight and management for TMED studies, in collaboration with the TMED operations lead, bioanalytical or modeling leads, procurement and clinical business operations or other internal cross-functional partners, as appropriate.
  6. Responsible for authoring translational medicine and clinical pharmacology components of TMED study protocols, clinical study reports, Investigator Brochures, briefing books, IND subsections, submission modules and other regulatory documents.
  7. Provide TMED subject matter expertise and lead the authoring of responses to health authority questions and inquiries.
  8. Participate in health authority meetings, as necessary.
  9. Prepare presentations TMED plans for governance meetings.
  10. Attend and actively participate in assigned asset development and sub-team meetings, clinical study team, modeling and vendor meetings.
  11. Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.

Required Education, Experience and Skills

  1. MD or PharmD (Post-Doctoral Fellowship preferred), clinical training preferred.
  2. Board certification in clinical pharmacology a plus.
  3. Excellent working knowledge of drug development, with specific expertise in translational medicine and clinical pharmacology principles including pharmacometrics, drug metabolism and human ADME, biomarkers, exposure-response assessment, and biopharmaceutics.
  4. Good working knowledge of regulatory guidances and requirements pertaining to early clinical development including clinical pharmacology guidelines and principles, exposure-response analysis guidances and principles pharmacokinetic and pharmacodynamic modeling (including population pharmacokinetic modeling), nonclinical guidelines and principles, biopharmaceutics guidelines, other clinical development guidances, as appropriate.
  5. Working knowledge of GCP, ICH and other regulatory standards.
  6. Ability to understand and interpret clinical and scientific information and data and communication thereof in written or oral form appropriate for the receiving audience.
  7. Skillful at technical writing with an ability to clearly and accurately summarize clinical and scientific information in written format.
  8. Track record of effective functional representation on product development teams.
  9. Excellent verbal and written communication skills.
  10. Collaborative mindset with a positive, transparent and inclusive approach as a representative or leader of cross-functional team(s).
  11. Functional capability with various software platforms including Microsoft Word, PowerPoint, Excel.
  12. A minimum of four years of experience in the pharmaceutical or biotech industry with a focus in early clinical development, translational medicine and/or clinical pharmacology.
  13. Post-doctoral, industry-sponsored PharmD Fellowship strongly preferred (for PharmD candidates).
  14. Experience in Women’s Health strongly preferred.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

#J-18808-Ljbffr

  • Director of Clinical Pharmacology

    2 days ago

    , GA, United States EPM Scientific - Phaidon International Full time

    We have a current opportunity for a Director of Clinical Pharmacology on a permanent basis. The position is fully remote. Key Responsibilities: Lead the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) studies. Develop clinical...

  • Director, Clinical Pharmacology

    2 days ago

    Paramus, NJ, United States SK Life Science Full time

    Director, Clinical Pharmacology Job Locations: US-NJ-Paramus ID: 2024-1840 Category: Clinical Operations Type: Regular Full-Time Overview The Clinical Pharmacology, Director role will effectively provide support for the design, execution, interpretation, and reporting of clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This individual will...

  • Director Clinical Pharmacology

    3 days ago

    King of Prussia, Montgomery County, United States CSL Behring Full time

    CSL Behring Director Clinical Pharmacology King of Prussia, Pennsylvania Apply Now CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in...

  • Associate Director of Clinical Pharmacology

    2 days ago

    , MA, United States EPM Scientific - Phaidon International Full time

    Key Responsibilities : Lead and contribute to the clinical pharmacology strategy, ensuring alignment with overall development plans and therapeutic goals. Design and oversee clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose optimization, and biomarker strategies. Interpret and analyze clinical pharmacology data,...

  • Director, Clinical Pharmacology

    3 days ago

    Foster City, CA, United States Dren Bio, Inc. Full time

    Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company's management team and scientific advisors have profound expertise covering the discovery and development of engineered antibodies designed to...

  • Director of Clinical Pharmacology Modeling and Simulation

    3 days ago

    Waltham, MA, United States GlaxoSmithKline Full time

    Site Name: Durham Blackwell Street, Upper Providence, WalthamPosted Date: Nov 13 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...

  • Director, Clinical Pharmacology

    2 days ago

    , MS, United States Immunovant, Inc. Full time

    Organizational Overview: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: The Clinical...

  • Senior Manager, Clinical Pharmacology

    2 days ago

    Waltham, MA, United States Deciphera Pharmaceuticals, Inc Full time

    Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by...

  • Director/Senior Director, DMPK and Clinical Pharmacology

    2 days ago

    South San Francisco, CA, United States IDEAYA Biosciences Full time

    What you’ll do: Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development, including authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products. One of the key roles of this position is to apply...

  • Principal Scientist

    4 weeks ago

    Cambridge, MA, United States Delphia Therapeutics Full time

    Principal Scientist / Associate Director, In vivo PharmacologyAbout Us:Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first-in-class targeted cancer...

  • Director, Clinical Pharmacology

    2 days ago

    Durham, NC, United States IQVIA Argentina Full time

    This position is Full-Time and Remote-based anywhere in the United States or Canada. Why DSSS? Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global...

  • Director of Clinical Pharmacology Modeling and Simulation

    2 days ago

    Collegeville, PA, United States GlaxoSmithKline Full time

    Site Name: Durham Blackwell Street, Upper Providence, WalthamPosted Date: Nov 13 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...

  • Director, Immunotherapy/ Immuno-Oncology, In Vitro Pharmacology

    3 days ago

    Boston, MA, United States Takeda Full time

    Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Join...

  • Director of Cell Therapy, In Vitro Pharmacology

    1 month ago

    Boston, MA, United States Takeda Pharmaceutical Full time

    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...

  • Expert/Director of Preclinical Research

    4 weeks ago

    Boston, MA, United States Qilu Pharmaceutical Full time

    Job responsibilities:Deeply understand the development goals and clinical value orientation of the project, as well as competition/clinical research/supervision/intellectual property/transformation and other cross-professional collaborative research needs, and deeply analyze the competition in the field of disease and positioning strategy of the project from...

  • Senior Clinical Pharmacology Leader

    3 days ago

    Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    At Vertex Pharmaceuticals, we are committed to innovative scientific research that transforms the lives of patients worldwide. Our team is seeking a highly skilled and experienced Sr. Clinical Pharmacology Leader to lead strategic initiatives and drive clinical development plans for new therapeutic entities.The successful candidate will possess a strong...

  • Clinical Pharmacology, Modeling and Simulation

    3 months ago

    Billerica, MA, United States Parexel International Corporation Full time

    Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally!We currently havetremendous opportunities available to join this extremely collaborative and super friendly team! If you're looking for an opportunity to...

  • Associate Director, Clinical Pharmacology

    3 days ago

    Lincoln, NE, United States Allergan Full time

    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...

  • Clinical Pharmacology, Modeling and Simulation

    7 days ago

    Billerica, MA, United States Parexel International Corporation Full time

    Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally!We currently havetremendous opportunities available to join this extremely collaborative and super friendly team! If you're looking for an opportunity to...

  • Scientific Associate Director, GI, Inflammation,

    3 weeks ago

    Boston, MA, United States Takeda Pharmaceutical Full time

    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...