Vice President, Clinical Pharmacology

About the Role >>> Vice President, Clinical Pharmacology

As the Vice President, Clinical Pharmacology reporting to the Chief Medical Officer, you will lead the development and execution of clinical pharmacology and pharmacometrics strategies across the Olema portfolio.  This is a fantastic opportunity for a driven Clinical Pharmacology professional to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women’s oncology company with significant potential to transform breast cancer treatments. 

This position is available in either our San Francisco or Boston office.

What You Will Do:

• Lead Clinical Pharmacology/PK/PD activities in collaboration and interaction with other functions
• Build and implement an overall clinical PK/PD development strategy to support all stages of drug development  
• Develop/manage infrastructure, budget, etc. for clinical pharmacology
• Prepare study synopses, protocols, study reports and regulatory documents to support the clinical pharmacology development 
• Identify/develop and apply 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 providing 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
• Responsible for evaluating technical, scientific aspects of all projects along with Clinical Pharmacology management
• Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions
• Lead Clinical Pharmacology regulatory documents writing, submission and response to Regulatory agency comments
• Perform functions and responsibilities with the highest regard for quality and timeliness
• Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software

What You Will Bring:

• 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 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
• Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment, balancing multiple responsibilities, projects, and teams simultaneously
• Ability to regularly present to the Executive Committee and to be clearly articulate, present and influence the decision making
• Ability to work well with external vendors and collaborators with courtesy and professionalism  

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

The base pay range for this position is expected to be $317,000 - $330,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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