Vice President, Clinical Pharmacology & Pharmacometrics

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.

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:

• 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:

• 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.

Knowledge, Skills and Abilities:

• 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.

• Environment: primarily working in office.

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.