Associate Director/Director, Clinical Pharmacology
About The Position
The Associate Director/Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising gene/base editing therapeutics. The candidate in this position should have strong scientific and technical skills, be well versed in PK and PD with a strong ability to critically evaluate and interpret data, conduct rapid exploratory analysis, quantitative systems pharmacology (QSP) and PKPD modeling. In this role, the candidate is expected to have strong data analyses, modeling, and critical thinking ability with good oral and written communication skills. The role could be tailored to focus solely on pharmacometrics or could be a hybrid Clinical Pharmacology/Pharmacometrics role based on the candidate’s experience and career aspirations. As a member of the clinical pharmacology department, this person is expected to operationalize model-based drug development, by integrating modeling results into clinical study design, regulatory documents, and internal decision-making.
Requirements
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmacology, Pharmaceutics or other relevant field with 3 to 10 years of experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience.
- Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development.
- Expertise in quantitative systems pharmacology (QSP).
- Expertise in pharmacokinetics, PKPD principles, ADME concepts, and clinical pharmacology.
- Expertise in Phoenix WinNonLin, NONMEM and R, or other pharmacokinetic, modeling and data visualization software.
- Strong communication skills (verbal and written) and presentation skills are required.
- Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.
- Experience and willingness to mentor and develop others.
- Expertise in translational modeling in in-vivo and ex-vivo gene editing therapeutics.
- Curiosity and enthusiasm to adopt to new modeling and data analyst approaches that facilitate new data or scientific insights.
Responsibilities
- Provide critical input in build-out of the Clinical Pharmacology function, including hiring of personnel and deployment of modeling infrastructure.
- Operationalize model-based drug development, including new methodology approaches as described in regulatory guidelines.
- Serve as key functional expert to lead, direct, and coordinate the activities of their assigned modeling projects.
- Conduct PK and PK/PD analyses and modeling using nonclinical and clinical data.
- Contribute to protocol and study report writings.
- Present key pharmacometrics analyses results to internal and external stakeholders.
- Facilitate model-based drug development across to support BEAM’s clinical programs.
- Develop and write pharmacometrics analysis plans, execute and author reports on results of analyses.
- Define and drive pharmacometrics contributions to regulatory/submission strategy and related documents.
- Provide strategic expertise and leadership for development programs based on relevant technical and disease area knowledge.
- In collaboration with cross functional partners, provide support for the quantitative evaluation of competing trial/analysis strategies.
- May manage portfolios at disease area/therapeutic area/indication level to support integration of pharmacometrics and relevant knowledge in the planning and execution of programs and strategies.
- Preparation of abstracts and manuscripts for publications.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
