Senior Manager Clinical Pharmacology

Sr. Manager, Clinical Pharmacology

6 month contract

Must be able to work on a W2

Hybrid in Waltham, MA 3x per week

We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join the team supporting the CNS therapeutic area as a key member of the Clinical Pharmacology, DMPK, and BA department. This individual will represent the function as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams. The position includes core scientific responsibility for selecting optimal doses and dosage regimens in patients, integrating knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). This role offers the opportunity to support multiple programs through participation on internal project working teams and will serve as a liaison between chemistry, life sciences, regulatory, and clinical operations. Hands-on modeling experience is desirable.

Requirements

• Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions.
• Conduct and oversee pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modeling.
• Present strategy and defend outcomes of model-based approaches to internal governance boards and regulatory agencies.
• Write or review clinical pharmacology components of regulatory documents and responses; participate directly in regulatory interactions.
• Promote model-informed drug discovery and development through external collaboration, journal publication, and conference presentation.
• Function effectively in a highly matrixed team environment.
• Serve as an active contributor on multi-disciplinary project teams, providing innovative and progressive input.
• Act independently within a highly matrixed clinical development organization and provide sound clinical pharmacology input to project teams.

Qualifications

• Ph.D. or PharmD in Pharmaceutical Sciences, Pharmacometrics, or related field with 3 years or 4 years of pharmaceutical industry experience.
• Demonstrated experience serving as a clinical pharmacology lead on development programs.
• Strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing current computational tools.
• Working knowledge of cross-functional interfaces relevant to drug development and detailed understanding of non-clinical and clinical DMPK processes.
• Programming experience in Phoenix required; additional experience in Monolix, R, WinNonlin, SAS, or Splus is desirable.
• Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; direct interaction with FDA including IND, NDA, and other submissions required.
• Experience in non-compartmental and model-based PK and PK/PD analyses and incorporating data into manuscripts, study reports, and regulatory submission documents (INDs, NDAs, CTDs).
• Excellent interpersonal, leadership, communication, and time-management skills; demonstrated experience managing internal and external personnel (including outsourced projects).
• Clinical pharmacology experience with small molecules desired.
• Experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME desired.
• Knowledge and experience in CNS therapeutics desired.
• Hands-on modeling experience desirable.