Associate Scientific Director Pharmacology
Job Summary
The Associate Scientific Director, Clinical Pharmacology will provide strategic leadership in developing clinical pharmacology plans for drug candidates within the Immunology therapeutic area. This role involves integrating clinical and quantitative pharmacology knowledge to optimize dosage regimens and study designs throughout the drug development lifecycle. The position requires strong expertise in PK/PD modeling and cross-functional collaboration to advance the understanding of pharmacological activity, efficacy, and safety.
Responsibilities
- Lead clinical pharmacology strategy for immunology programs.
- Execute clinical pharmacology plans and quantitative analysis.
- Represent function in study teams and regulatory interactions.
- Oversee PK/PD data interpretation and dosage regimen optimization.
Required Skills
- PhD/PharmD in Pharmacology or related fields.
- 5+ years industry experience in Clinical PK/PD.
- Proficiency in PK/PD modeling (Phoenix, R, NONMEM).
- Expertise in regulatory guidelines and clinical study design.
Job Details
Responsibilities:
- Provide clinical pharmacology expertise to program and study teams throughout a molecule's lifecycle (discovery through development).
- Provide functional representation on development programs and study teams and identify opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy, and safety.
- Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical).
- Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies.
- Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results.
- Conduct hands-on quantitative analysis and present the findings to multidisciplinary project teams.
- Serve as lead author and key contributor to clinical pharmacology sections of documents.
- Serve as the subject matter expert in interactions with Health Authorities.
- Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed.
- Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes.
- Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent.
Qualifications:
- PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields.
- 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD).
- Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles.
- Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies.
- Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm.
- Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data.
- Hands-on experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses.
- Experience with Model Informed Drug Development (MIDD) paired meeting program is a plus.
- Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM. Experience with Monolix and MATLAB is a plus.
- Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards.