Associate Director, Pharmacology
Location
Waltham, MA | United States
Job description
Job Title: Associate Director, Pharmacology
Location: Middlesex County, MA (For Local-4 days onsite per week)
- For Remote-in office once a quarter and for 2 meetings per year in May and November for a couple of days
Hours/Schedule: Regular Business Hours EST
Compensation: $175K to $200 for the right candidate (DOE)
Type: FTE
Position Summary: The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
This position will report to Director, Clinical Pharmacology, and be located in the MA office or may be remote.
Key Responsibilities: Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.)
Represent the department as subject matter expert on cross-functional project teams and be able to influence team strategy.
Author and review relevant sections of clinical study protocols, analysis plans, study reports, and regulatory submissions.
Contribute to regulatory submissions and health authority agency interactions relevant to clinical pharmacology including but not limited to pre-meeting briefing packages, INDs, IBs, queries and information requests, 2.7.1 & 2.7.2 modules and label discussions.
Independently plan and conduct hands-on analyses, including NCA, population PK and PK/PD analyses, exposure-response analyses, PBPK analyses, to answer development questions and to inform clinical development strategy.
Develop and maintain collaborative relationship with colleagues within the department, internal stake holders (i.e., DMPK, toxicology, biology, translational medicine, medical, clinical, biometrics, regulatory, clinical operations, CMC, etc.) and external vendors.
Manage external vendors to perform PK, PBPK, population PK and PK/PD, exposure-response analyses in support of early clinical programs and regulatory submissions.
Required Qualifications: Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with 5 years of clinical pharmacology industry experience or M.S. with 10 years of relevant experience.
Leadership potential, effective and clear written and verbal communication, problem solving, and presentation skills are essential for the role.
Strong project management skills and ability to prioritize and manage multiple projects simultaneously.
Strong understanding of clinical pharmacology concepts and proficiency in conducting clinical pharmacology studies.
knowledge of regulatory requirements related to clinical pharmacology, M&S, and drug development and record of contribution to INDs, CTAs, CSRs, NDAs, and MAAs as well as experience with regulatory agency interactions.
Hands-on experience with standard PK and M&S software (e.g., Phoenix, NONMEM, R, Monolix, MATLAB) to drive M&S activities (e.g., population PK and PK/PD, exposure-response, PBPK)
Previous experience in oncology indications is preferred.
Demonstrated ability to work effectively and collaboratively on cross-functional teams.
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