Clinical Pharmacology Lead (Associate Director) (MIDD)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Cambridge, Massachusetts, United States. Hybrid role requiring residence within commuting distance and on-site work an average of 2.5 days per week or more as needed. Permanent U.S. work authorization is required; U.S. work visa sponsorship is not available.
Annual base salary: $139,100–$231,900, plus a 17.5% bonus target and eligibility for a share-based long-term incentive program.
Company
develops medicines and applies model-informed drug discovery and development approaches to support evidence-based drug development.
What you will do
- Represent Clinical Pharmacology on clinical, development, and other multifunctional project teams.
- Design and execute clinical pharmacology plans and end-to-end MIDD strategies for Internal Medicine projects.
- Plan and oversee protocol authoring, clinical phase activities, PK/PD analyses, biomarker and immunogenicity measurement strategies, and study reporting.
- Develop dose-range finding strategies and optimize doses, dosage regimens, and clinical study designs.
- Provide clinical pharmacology contributions to regulatory documents, including IND, NDA/MAA, investigator brochures, briefing documents, and regulatory responses.
- Develop methodologies through internal and external collaborations, publish findings, present at scientific events, and coach less experienced colleagues.
Requirements
- MD, PhD, PharmD, or equivalent training and experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or a related discipline.
- At least 5 years of industry experience in clinical pharmacology, clinical PK/PD, pharmacometrics, or systems pharmacology.
- Strong quantitative expertise in mechanistic PK/PD modeling, systems pharmacology, literature meta-analysis, population modeling, and clinical trial simulations.
- Experience with quantitative pharmacology approaches and tools such as NONMEM and R.
- Leadership, collaboration, coaching, communication, and presentation skills, with the ability to influence multifunctional teams.
- Ability to work in the United States with permanent work authorization; visa sponsorship is not available.
Culture & Benefits
- Hybrid work arrangement with on-site collaboration in Cambridge.
- Opportunities for professional growth and learning within Clinical Pharmacology.
- 401(k) plan with matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
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