Job Title: Director, Clinical Pharmacology
Department: R&D: Clinical
Reports To: Vice President of Clinical Pharmacology
FLSA Status: Exempt
Location: San Diego or Remote
Travel: up to 20%
The Director, Clinical Pharmacology (CP) will report to the VP of Clinical Pharmacology and will be a core-member of the cross-functional product development and clinical development teams. This individual will be responsible for leading efficient, innovative clinical pharmacology programs incorporating the most current scientific advances in the field and incorporating knowledge of quantitative pharmacology, drug metabolism and transporters, statistical principles to support Phase 2 and 3 clinical programs. This individual will be responsible for assigned programs and studies and accountable for all aspects of Clinical Pharmacology from protocol design, authoring, data analysis and interpretation to reporting and authoring study reports, regulatory documents, and publications. He/she will work collaboratively with CMC and non-clinical DMPK colleagues to ensure data and formulations necessary to support clinical development are planned for and delivered in a timely manner.
- Responsible for developing Clinical Pharmacology strategy; Phase 1 protocol design, data analysis/interpretation, and reporting by authoring study reports, regulatory documents, and publications. This includes determining scope, design, planning, and analysis of phase 1-4 PK-PD studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective
- Operational oversight of Phase 1 studies and clinical studies with PK sampling to ensure data quality and fidelity
- Identify and manage consultants and vendors supporting clinical pharmacology studies
- Lead authoring for Sections 2.7.1 and 2.7.2, with contributions to clinical safety and efficacy summaries of IND and NDAs. Respond to regulatory queries during reviews and represent at face-to-face regulatory meetings
- Responsible for quality aspects of Phase 1 studies and be prepared to answer questions during regulatory inspection
- Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, pharmaceutical formulations, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development
- PhD in Pharmaceutical Sciences, Clinical Pharmacology, Clinical Medicine, or relevant Biological Sciences is required. PharmD-PhDs are preferred.
- Strong quantitative skills are required, along with a thorough understanding of drug metabolism and transporters.
- 10+ years of relevant Pharmaceutical and/or Biotech work experience; small molecule development experience is a must; pediatric drug development experience is a plus
- Experienced in designing and overseeing operations for Phase 1 studies for small molecules.
- Demonstrated understanding and application of model-based drug development (MBDD) including PK-PD modeling, Population PK modeling, Exposure-Response analyses for safety and efficacy, physiological based modeling and simulation, pediatric drug development, model-based meta-analyses, trial simulations, innovative clinical trial design, statistical principles
- Good understanding of regulatory requirements for US and EU (at a minimum) and other international authorities.
- Knowledge of bioanalytical methods and regulatory requirements; ability to work with bioanalytical labs
- Working knowledge of biopharmaceutics principles to guide formulation development
- In depth understanding of clinical and regulatory landscape, disease pathophysiology and mechanisms of drug action, biomarkers, available treatment paradigms, and patient populations
- Record of publications and presentations at professional organizations
- Strong scientific reasoning ability
- A breadth of diverse leadership experience and capabilities including: the ability to influence and collaborate with peers, develop, and coach others, and oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
- Ability to problem-solve, research issues, and propose solutions
- Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly
- Ability to function independently in fast-paced, virtual environment