SUMMARY/JOB PURPOSE:

The VP, Clinical Pharmacology builds and leads an experienced team of clinical pharmacologists with responsibilities to integrate clinical pharmacology strategies across pre-clinical and clinical development, including drug approval and post-approval activities. The incumbent has a strong understanding of pharmacokinetics, pharmacometrics, compartmental modeling and simulation, and statistical methodologies utilizing the latest computational approaches and tools, and a proven ability to lead and drive clinical pharmacology strategy for oncology programs. This role is an integral part of the Discovery and Translational Research Leadership Team and partners with leaders in discovery, translational medicine, toxicology, early and late clinical development, CMC, and other R&D stakeholders.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Build and supervise a team of clinical pharmacology leaders equipped with the latest tools and capabilities.
• Supervise established teams in Bioanalysis and Biosample Management.
• Develop strategies for departmental delivery, growth and innovation.
• Establish and oversee internal and cross-department processes and best practices.
• Conduct gap analyses and supervise the development of clinical pharmacology methods to assist clinical drug development for pipeline assets.
• Oversee the design and review of 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 model-informed drug development (MIDD) approaches to support key components of clinical development plans (e.g. dose-optimization, special population considerations, benefit-risk evaluations) across all modalities including small molecules, antibody-drug conjugates and bispecific antibodies.
• Network and collaborate with other functional areas including Discovery and Translational Research, Clinical Development, Development Operations, Quality Assurance and Regulatory to deliver on project team and corporate objectives.
• Participate in development governance committees.
• Manage clinical pharmacology 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.

SUPERVISORY RESPONSIBILITIES:

• 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.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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.

Experience/The Ideal for Successful Entry into Job:

• Proven ability to build and lead strong teams.
• Ability to communicate and collaborate with other functional areas including drug discovery, nonclinical toxicology, 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.

Knowledge/Skills:

• A broad understanding of drug development as evidenced by a track record of significant contributions to successful Regulatory Agency interactions, INDs, NDAs, drug approvals, in-licensing deals, patents, and/or peer reviewed publications.
• Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biotherapeutics; 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 nonlinear mixed-effects modeling software is required.
• Familiarity with statistical methodologies and software for conducting PK/PD and exposure-response data analysis.
• Scientific writing and presentation skills are essential; peer reviewed publications in a relevant field required.

JOB COMPLEXITY:

• 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.

WORKING CONDITIONS:

• Environment: primarily working in office.

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