Clinical Pharmacology Leader

7 days ago

San Francisco, California, United States Olema Oncology Full time
About the Role

Olema Oncology is a pioneering cancer medicines company dedicated to transforming breast cancer treatments. Our lead program, palazestrant (OP-1250), is a groundbreaking oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented and passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer.

Key Responsibilities
  • Lead Clinical Pharmacology/PK/PD activities in collaboration and interaction with other functions
  • Develop and implement an overall clinical PK/PD development strategy to support all stages of drug development
  • Prepare study synopses, protocols, study reports, and regulatory documents to support the clinical pharmacology development
  • Identify and develop new quantitative methods as needed to solve problems in pharmaceutical research and drug development
  • Advance PK/PD modeling and simulation approaches focusing on oncology therapies
  • Manage study PK operations with CRO/CDMOs and contracted vendors and proactively provide technical input on quantitative issues
  • Provide scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans
Requirements
  • PhD with 10+ years progressive industry experience and expertise in one or more areas related to pharmacometrics, clinical pharmacology, or preclinical ADME studies
  • Prior experience with managing a team of clinical pharmacology experts is essential
  • Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometrics activities from planning, implementation through completion across multiple projects
  • Project management skills such as scope management, progress tracking/driving, as well as time management
  • Strong competency in building mathematical models is required (in commonly used languages such as WinNonlin Phoenix, NONMEM, S-Plus/R)
  • Experience with PK/PD modeling with demonstrated quantitative skills
  • Broad translational and clinical development expertise with emphasis on pharmacometrics
  • Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings is preferred
  • Familiar with regulatory guidance especially for drug interaction studies
  • Demonstrated experience in writing study reports and regulatory documents
Personal Characteristics
  • Excellent verbal and written communication and skills
  • Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
  • A commitment to excellence
  • Leadership and collaboration skills: Balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
  • A 'difference maker' in terms of one's professionalism and contributions
  • Impeccable professional ethics, integrity, and judgment
  • Collegial, hard-working, confident, and autonomous

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