Senior Director, Clinical Pharmacology

Role Summary

The Senior Director, Clinical Pharmacology will be a key member of the development team, developing clinical pharmacology strategy suitable for the target product profile and clinical development plan, leading the design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies, and serving as the clinical pharmacology lead on studies and project teams. The role supports projects at various stages of development, enabling involvement in drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. Location: San Diego, California.

Responsibilities

• Develop clinical pharmacology strategy and related clinical development plan consistent with the target product profile, program goals, and the US/international regulatory guidance/guideline of small molecule therapeutics.
• Collaborate with DMPK, clinical research, and CMC teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label.
• Determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization.
• Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis.
• Contribute to the design Phase 1 clinical pharmacology studies (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.).
• Participate in the selection of Phase 1 CROs for clinical pharmacology studies.
• Accountable and responsible for the analysis and interpretation of PK and PK/PD data.
• Participate in preparation of clinical study protocol and report.
• Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies.
• Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to insure integration of modern clinical pharmacology principles into project plans and study design.
• Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expert.
• Focus on both immediate/short-term (<2 Years) and long range (5 years) strategic planning to determine function objectives.
• Lead, direct, manage, develop, coach/mentor, and evaluate direct reports, contributing to budget and headcount planning.
• Other duties as assigned.

Education

• Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles.

Qualifications

• Required: 10+ years of significant industry experience in conduct and/or oversight of clinical pharmacology function, studies, and data analysis, and a minimum of 10 years of experience in a supervisory role. 13 years of overall professional experience is required.
• Required: Familiarity with all stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects.
• Required: Demonstrated ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compounds.
• Preferred: Expertise/experience in multiple clinical pharmacology areas is preferred - FIH and/or Ph II/III dose selection, pediatric dose selection, drug-drug interactions, enzymology of drug metabolism, formulation bridging, bioequivalence, food-effect, exposure-QTc assessments, special population, and radiolabeled mass balance studies.
• Required: Extensive experience in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings.
• Required: Experience in working in a cross functional team/matrix environment with strong vendor management skills.
• Required: Competent in the use of PK and PK/PD Modeling software tools such as Phoenix.
• Required: Strong written, presentation, and verbal communication skills.
• Required: Critical thinker with strong problem-solving skills.
• Required: Ability to influence business leaders at all levels.
• Preferred: Prior experience in population PK and exposure-response analysis is a plus but not required.

Additional Requirements

• Physical Demands: On a continuous basis, sit at a desk for long periods of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
• Travel: You may be required to travel for up to 5% of your time.