Executive Director, Quantitative Pharmacology and Pharmacometrics
Merck
5 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Primary Responsibilities:
- Lead a team of up to 7 QP2 scientists (people management, scientific/operational oversight) under the Immunology Therapeutic Area Head.
- Provide day-to-day scientific oversight leveraging end-to-end drug discovery/development expertise.
- Shape clinical pharmacology regulatory strategy and ensure high-quality regulatory documents (INDs, CSRs, CTDs).
- Identify, prioritize, and develop enabling modeling platforms (disease, mechanistic, comparator models) to deliver an end-to-end differentiated immunology portfolio.
- Implement quantitative clinical pharmacology, pharmacometrics, and translational modeling to inform key decisions and streamline development.
- Serve as an expert in cross-functional/governance discussions (including business development/licensing evaluations).
- Set priorities, drive performance management, hiring/retention, staff development, training, and talent calibration.
- Contribute to resource allocation; foster a collaborative, high-performing culture.
Education:
- Ph.D./PharmD (or equivalent) with at least 12 years’ experience with increasing responsibility/independence in pharmaceutical drug development or regulatory.
Required Experience and Skills:
- Background in biopharmaceutics/pharmaceutical sciences/pharmacometics/engineering/computational biology or related field.
- Immunology therapeutic area and translational science knowledge.
- Regulatory strategy experience in immunology; independently authoring/defending filings for marketing authorization (NDA/MAA).
- Extensive experience developing quantitative strategies impacting pipeline decisions across phases, including complex modalities.
- Strong understanding of drug R&D functional deliverables; ability to connect QP2 contributions to broader needs.
- Ability to lead interdisciplinary teams/taskforces and drive results through others.
- Inclusive, high-performance collaboration; manage ambiguity; strong written/verbal communication and planning.
Preferred:
- Mechanistic modeling and/or population PK/PKPD analyses using standard software (e.g., MATLAB, NONMEM, R, Monolix, Phoenix).
- Biopharm/ADME understanding across modalities; record applying mechanistic models to decisions.
- External visibility via publications/presentations/professional org leadership.
Benefits/Compensation (if applicable in posting):
- Salary range: $231,900.00–$365,000.00; eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Apply by the application deadline stated on the posting.
- Lead a team of up to 7 QP2 scientists (people management, scientific/operational oversight) under the Immunology Therapeutic Area Head.
- Provide day-to-day scientific oversight leveraging end-to-end drug discovery/development expertise.
- Shape clinical pharmacology regulatory strategy and ensure high-quality regulatory documents (INDs, CSRs, CTDs).
- Identify, prioritize, and develop enabling modeling platforms (disease, mechanistic, comparator models) to deliver an end-to-end differentiated immunology portfolio.
- Implement quantitative clinical pharmacology, pharmacometrics, and translational modeling to inform key decisions and streamline development.
- Serve as an expert in cross-functional/governance discussions (including business development/licensing evaluations).
- Set priorities, drive performance management, hiring/retention, staff development, training, and talent calibration.
- Contribute to resource allocation; foster a collaborative, high-performing culture.
Education:
- Ph.D./PharmD (or equivalent) with at least 12 years’ experience with increasing responsibility/independence in pharmaceutical drug development or regulatory.
Required Experience and Skills:
- Background in biopharmaceutics/pharmaceutical sciences/pharmacometics/engineering/computational biology or related field.
- Immunology therapeutic area and translational science knowledge.
- Regulatory strategy experience in immunology; independently authoring/defending filings for marketing authorization (NDA/MAA).
- Extensive experience developing quantitative strategies impacting pipeline decisions across phases, including complex modalities.
- Strong understanding of drug R&D functional deliverables; ability to connect QP2 contributions to broader needs.
- Ability to lead interdisciplinary teams/taskforces and drive results through others.
- Inclusive, high-performance collaboration; manage ambiguity; strong written/verbal communication and planning.
Preferred:
- Mechanistic modeling and/or population PK/PKPD analyses using standard software (e.g., MATLAB, NONMEM, R, Monolix, Phoenix).
- Biopharm/ADME understanding across modalities; record applying mechanistic models to decisions.
- External visibility via publications/presentations/professional org leadership.
Benefits/Compensation (if applicable in posting):
- Salary range: $231,900.00–$365,000.00; eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Apply by the application deadline stated on the posting.