Job Title: Vice President, Head of Clinical Pharmacology
Reports To: Chief Medical Officer
Department: R&D
Department Code: 3010
People Manager: Yes
FLSA Status: Exempt
Location: Remote or Hybrid
Summary
The Vice President of Clinical Pharmacology will be responsible for the design, leadership, and implementation of Clinical Pharmacology and Modeling & Simulation strategies across Longboard’s development programs. This individual will work in close collaboration with colleagues in Clinical Development, Clinical Operations, Biostatistics, Non-clinical Development, Bioanalysis, Medical Affairs, Project Management, Research, Technical Operations, and Regulatory to execute the company’s overall development strategy, participate on cross-functional project teams, and lead interactions with global health authorities. S/he will also play a key role in building the Clinical Pharmacology function and capabilities at Longboard. To be successful in this leadership role, the individual will have demonstrated management skills, be self-motivated, able to work well in cross-functional teams, and must have a strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.
Responsibilities
- Responsible for the Clinical Pharmacology function and capabilities, through the recruitment and training of clinical pharmacologists and management of contractors.
- Design, implement, and lead the clinical pharmacology and modeling & simulation strategies and plans for Longboard development compounds from pre-IND and first-in-human testing through later phases of clinical development, including pivotal Phase 2/3 studies and global regulatory submissions.
- Develop clinical pharmacology study designs and help prepare study protocols and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
- Collaborate with Clinical Operations to oversee, contract, and manage clinical pharmacology studies.
- Leadership and participation on cross functional teams as clinical pharmacology expert to ensure proper integration of these activities into overall project plans.
- Contribute to the analysis of data, including hands-on or externally contracted PK/PD data analysis and advanced modeling and simulation, from nonclinical and clinical studies.
- Write, edit, and finalize sections of regulatory documents, and interact with global health authorities as needed.
- Interpret, summarize, and present data to internal project teams, senior management, and external partners/organizations.
- Contribute to departmental processes such as SOP’s, operational support, templates, etc.
- Maintain a current understanding of regulatory guidance, relevant literature and methodologies, as well as the scientific literature related to specific Longboard pipeline programs.
Qualifications
- Ph.D. in Pharmacokinetics, Mathematics, Pharmacology, or related scientific discipline required,with 15+ years of biotech/pharmaceutical drug development experience.
- Expertise in small molecule clinical pharmacology.
- Regulatory experience required, such as IND/CTA filings and/or NDA/MAA/PMDA submissions.
- Prior experience leading all aspects of Clinical Pharmacology for an early-stage small molecule program, including pivotal trial design, Health Authority interactions, NDA/MAA filings, label negotiations, approval, and commercialization.
- Extensive experience in biopharmaceutics required. This individual will work in close collaborations with colleagues and vendors in Technical Operations to develop formulation strategies and PK bridging strategies to support molecule progress.
- Experience required in leading the design and/or analysis of clinical pharmacology studies (e.g., relative bioavailability, drug-drug interaction, special populations – hepatic and renal impairment, pediatric, human ADME, etc.
- Hands-on experience with clinical PK and PK/PD data analysis required (e.g., Phoenix WinNonlin); hands-on experience with advanced modeling and simulation (e.g., Pop PK, PBPK) strongly preferred.
- Experience with outsourcing, overseeing, and managing clinical pharmacology and/or modeling & simulation activities at vendors preferred.
- Familiarity with ICH/FDA/EMA guidelines for the conduct of clinical pharmacology studies to support regulatory filings
- Required experience in authoring regulatory submissions, as well as multiple INDs and preparing detailed science-based responses to regulatory questions.
- Ability to multi-task and change quickly to changing priorities
- Strong written and oral communication skills and a track record of achievement in publications
- Ability to work collaboratively within cross-functional teams
- Prior management experience required; some prior experience in helping to build a clinical pharmacology department is strongly preferred.