The Clinical Pharmacology & Pharmacometrics Director is responsible for developing and implementing clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of development. The individual will serve as the clinical pharmacology/pharmacometrics lead on project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions and quantitative pharmacology.
Requirements
- Develop and implement clinical pharmacology and pharmacometric strategies
- Serve as the clinical pharmacology/pharmacometrics lead on project teams
- Oversee and/or conduct PK/PD and exposure-response analyses
- Work collaboratively with functional partners
- Drive external scientific visibility and publication objectives
- Assure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards
- Mentor and may supervise 1 or 2 regular employees
- Have a PhD or PharmD in pharmaceutical sciences, pharmacology or a related discipline and a minimum of 8 years of drug development experience
- Have experience in development of small and/or large molecules and new modalities
- Have experience in the Oncology therapeutic area
- Have contributions to translational science and precision medicine objectives
- Have hands-on modeling and simulation skills using NONMEM, R and/or other modeling and simulation software
- Have a current knowledge of regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biologics
- Have excellent interpersonal, verbal and written communication skills
- Have the ability to communicate and collaborate cross-functionally
- Have a record of supporting drug candidates at various stages of development within the clinical pharmacology function
- Have demonstrated impact on drug development decisions through quantitative approaches with strong leadership skills and the ability to influence
- Have the ability to develop and deliver effective presentations and written/oral communications
- Be able to thrive in a fast-paced business environment
- Have applied knowledge of GLP and GCP regulations
- Be able to function in a highly matrixed team environment
- Be able to find creative solutions to unique and complex problems
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
