This role will be pivotal in driving the clinical pharmacology strategy for our biologics programs, from pre-IND through to post-approval. The successful candidate will integrate clinical pharmacology knowledge with a broad understanding of related disciplines to support and impact development decisions.
Key Responsibilities:
- Lead the design and implementation of clinical pharmacology studies for biologics, including PK/PD modeling and simulation.
- Provide scientific oversight for preclinical PK/TK studies and clinical pharmacology studies.
- Collaborate with cross-functional teams including clinical development, regulatory, bioanalytical, and biostatistics to ensure robust study designs and data analyses.
- Develop and apply innovative modeling and simulation strategies to optimize dose selection and study design.
- Analyze and interpret PK/PD data to support dose selection, study design, and proof-of-concept.
- Prepare and review regulatory documents including INDs, NDAs, and BLAs.
- Serve as the clinical pharmacology expert on project teams, providing strategic input and guidance.
- Manage relationships with external vendors and consultants to ensure high-quality deliverables.
Qualifications:
- PhD, PharmD, or equivalent in pharmacokinetics, pharmaceutical sciences, or related discipline.
- Minimum of 5 years of experience in clinical pharmacology within the pharmaceutical or biotechnology industry, with a focus on biologics.
- Strong expertise in PK/PD modeling and simulation, including population PK and PBPK modeling.
- Experience with regulatory submissions and interactions.
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
- Strong analytical and problem-solving skills, with the ability to interpret complex clinical data.
Preferred Qualifications:
- Experience in autoimmune diseases and/or immunology.
- Familiarity with anti-FcRn technology and its clinical applications.
- Proven track record of successful regulatory submissions for biologics.
