Vice President, Clinical Pharmacology & Pharmacometrics

Exelixis • Alameda, CA

1d • Onsite

About The Position

SUMMARY/JOB PURPOSE (Basic purpose of the job): The Vice President, Clinical Pharmacology and Pharmacometrics builds and maintains an experienced team of clinical pharmacologists and DMPK scientists with responsibilities to integrate clinical pharmacology strategies from pre-clinical to clinical development and drug approval. The incumbent has a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools. The Vice President, Clinical Pharmacology and Pharmacometrics is part of the Development Sciences Leadership Team and partners with leaders in discovery, translational medicine, data and statistical sciences, early and late clinical development and other R&D stakeholders. ESSENTIAL DUTIES/RESPONSIBILITIES: Build and supervise a team of clinical pharmacology and DMPK leaders equipped with latest tools and capabilities. Develop strategies for departmental delivery, growth and innovation. Conduct gap analysis and supervise the development of clinical pharmacology and DMPK methods to assist clinical drug development for pipeline assets from discovery to pivotal programs. Oversee the design and review clinical pharmacology study protocols and support clinical trials, pharmacokinetic/pharmacodynamic modeling and analyses, and regulatory documents as well as lead clinical pharmacology aspects of regulatory interactions. Lead and promote the use of leading-edge clinical pharmacology, DMPK and model-based drug development (MBDD) approaches. Network and collaborate with other functional areas including Research, Clinical Development, Data and Statistical Sciences, Clinical Operations, Quality Assurance and Regulatory to deliver on project team and corporate objectives. Maintain communication with corporate executives and participate in corporate governance committees. Manage clinical pharmacology and DMPK activities related to budget planning, vendor identification, outsourcing of PK, PK/PD analyses and contract requisition. Collaborate with corporate partners in joint drug development. Lead functional area reviews for due diligence evaluations. Drive external visibility and publication objectives.

Requirements

• PhD degree in pharmaceutical sciences, pharmacology or a related discipline and a minimum of seventeen years of related experience; or, Equivalent combination of education and experience.
• Proven ability to build and lead strong teams.
• Ability to communicate and collaborate with other functional areas including drug discovery, nonclinical safety assessment, CMC, clinical development, quality assurance and regulatory affairs.
• Ability to guide major projects to successful completion, develop, guide and deliver corporate objectives.
• Excellent interpersonal, leadership, communication and time management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
• A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs, Regulatory Agency interactions, NDSs, drug approvals, in-licensing deals, and/or peer reviewed publications.
• Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA and other regulatory agencies, including submission of IND, NDA and other regulatory documents is required.
• Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate.
• Hands-on experience in utilizing modeling software is required.
• Familiarity with statistical approaches and programs for data analysis.
• Scientific writing and presentation skills are essential; peer reviewed publications in a relevant field required.
• Develop and deliver on departmental and corporate objectives.
• Build and manage high performance teams.
• Effectively manage R&D collaborations with other companies.
• Establish collaborative networks between functional areas.
• Find solutions to unique and complex problems.
• Operate within allocated departmental budget.

Responsibilities

• Build and supervise a team of clinical pharmacology and DMPK leaders equipped with latest tools and capabilities.
• Develop strategies for departmental delivery, growth and innovation.
• Conduct gap analysis and supervise the development of clinical pharmacology and DMPK methods to assist clinical drug development for pipeline assets from discovery to pivotal programs.
• Oversee the design and review clinical pharmacology study protocols and support clinical trials, pharmacokinetic/pharmacodynamic modeling and analyses, and regulatory documents as well as lead clinical pharmacology aspects of regulatory interactions.
• Lead and promote the use of leading-edge clinical pharmacology, DMPK and model-based drug development (MBDD) approaches.
• Network and collaborate with other functional areas including Research, Clinical Development, Data and Statistical Sciences, Clinical Operations, Quality Assurance and Regulatory to deliver on project team and corporate objectives.
• Maintain communication with corporate executives and participate in corporate governance committees.
• Manage clinical pharmacology and DMPK activities related to budget planning, vendor identification, outsourcing of PK, PK/PD analyses and contract requisition.
• Collaborate with corporate partners in joint drug development.
• Lead functional area reviews for due diligence evaluations.
• Drive external visibility and publication objectives.
• Supervises staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions or terminations.
• Attract, retain, mentor and develop clinical pharmacology team members.
• Develop talent strategy to create an industry-leading clinical pharmacology organization.

Benefits

• Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree