Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated 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 passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
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 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.
- Responsible for evaluating technical, scientific aspects of all projects along with Clinical Pharmacology management.
- Review clinical protocols and scientific reports for regulatory filings and anticipate 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.
- Maintain 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 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 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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Important Information
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.
