Job title: Senior/Director, Clinical Pharmacology & Pharmacometrics
Company: Orbis Clinical
Job description: The Senior Director, Clinical Pharmacology & Pharmacometrics has strong scientific, technical and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of the development. Working closely with partners from discovery and development, the individual is responsible for providing strategic and technical subject matter expertise as will as scientific oversight for the clinical pharmacology and pharmacometrics support of several programs in companies portfolio. The Senior Director contributes to growth of the department and will mentor or manage junior clinical pharmacologists.
- Develop, implement and/or supervise clinical pharmacology and pharmacometric strategies to drive company programs through all the stages from research through post-marketing
- Serve as the clinical pharmacology lead on several project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions and quantitative pharmacology
- Progress small molecules and biologics through development milestones including IND/CTA, EOP2 and marketing applications
- Oversee and/or conduct PK/PD and exposure-response analyses using relevant state of the art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publications
- Work collaboratively with functional partners including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations and Regulatory to deliver on project and corporate objectives
- Support functional area reviews for due diligence evaluations
- Drive external scientific visibility and publication objectives
- Work with internal and external scientific experts to evaluate new methods to maintain cutting edge techniques, models, and capabilities
- Assure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards in the clinical pharmacology programs
- Train and mentor junior staff to develop and expand their expertise and encourages them to create innovative solutions that will increase scientific knowledge and technical capabilities
SUPERVISORY RESPONSIBILITIES:
- Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, salary review, promotion, transfer, demotion, or termination.
- Directly supervises full time employees.
Compensation Details:
- Compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.
- The base pay range for this position is $246,000 – $348,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location.
- The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Expected salary:
Location: Alameda, CA
Job date: Fri, 14 Feb 2025 23:40:03 GMT
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