Title: Associate Director, Clinical Pharmacology
Location: Thousand Oaks, CA or San Francisco, CA
Position Description:
Reporting to the Head of Clinical Pharmacology, the Associate Director, Clinical Pharmacology will work in our clinical development teams, with significant responsibility for the Clinical Pharmacology package of multiple clinical and Pre-IND programs. In this role, you will help formulate clinical pharmacology strategies from the FIH through registration.
Primary Responsibilities:
- As part of the development team, you will provide expertise in the clinical development of small molecule programs, in particular the design and oversight for clinical pharmacology studies.
- Lead and manage design and conduct of clinical pharmacology studies of increasing complexity.
- Analyze, interpret and author documents for clinical submissions, including but not limited to clinical study protocols and reports, Investigator's Brochures, and the clinical pharmacology sections of regulatory submissions.
- Interact with regulatory agencies (US and ex-US) as needed.
- You will be accountable for study-to-program level clinical pharmacology aspects of compounds in the discovery to development stage.
- You will be responsible for oversight and interaction with consultants and vendors assigned to support clinical pharmacology tasks including PK, PKPD, and clinical assay development.
Qualifications and Requirements:
- PharmD or PhD in a relevant discipline preferred.
- 8+ years of experience in Clinical Pharmacology supporting early development in a biotech or pharmaceutical organization.
- Prior, robust clinical pharmacology experience with small molecules is required. Experience in the design and conduct of multiple types of Phase 1 studies (e.g. FIH, DDI, FE, rBA, etc.) preferred.
- Proficiency with modern PK analysis software (e.g. Phoenix WinNonLin) required.
- Knowledge of regulatory requirements for clinical pharmacology preferred.
- Strong interpersonal skills, and ability to influence development program teams.
- Excellent verbal and written communication skills, and ability to clearly convey complex concepts to technical and non-technical audiences preferred.
- Ability to work independently in a dynamic and fast-paced environment.
- Experience in therapeutic areas related to pain management preferred.
- Experience with regulatory submissions in early and late development is preferred.
