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Salary: USD 230,000 - 250,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company focused on transforming oncology care, particularly in breast cancer treatment. The company's lead product candidate, palazestrant, is a novel estrogen receptor antagonist currently in two pivotal Phase 3 clinical trials, with top-line data expected in Q1 2027 and potential commercial launch in 2028. A follow-on candidate, OP-3136, is a KAT6 inhibitor in development for metastatic breast cancer and prostate cancer indications.
As Director of Global Regulatory Affairs - Strategy Lead, you will report to the Senior Director of Regulatory Affairs and lead the development and execution of innovative regulatory strategies supporting Olema's product portfolio. You will serve as the regulatory subject matter expert on cross-functional teams, providing guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.
Key responsibilities include:
- Provide regulatory leadership to the lead asset's clinical studies and develop global registrational strategies
- Develop innovative global regulatory strategies for the Olema portfolio in clinical development and life-cycle management with minimal supervision
- Represent Regulatory Affairs on cross-functional teams as SME, providing regulatory guidance and oversight
- Stay current with the regulatory landscape and requirements impacting drugs, biologics, and devices
- Lead development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.)
- Represent Olema with global health authorities and lead agency interactions
- Identify gaps and develop risk mitigation strategies for regulatory submissions
- Ensure Olema's regulatory activities comply with Health Authority requirements
- Coordinate and maintain Health Authority reporting schedules in collaboration with cross-functional teams
- Lead development of Regulatory Affairs department policies, SOPs, and work instructions
- Provide regulatory guidance and leadership on software implementation for regulatory dossiers (e.g., Veeva)
- Keep leadership informed of regulatory landscape changes and Health Authority initiatives
- Lead the global regulatory team(s) and ensure execution of regulatory strategies
- Mentor and develop regulatory colleagues in the department
- Support senior leadership of Regulatory Affairs as required
The role is based in Boston, MA or San Francisco, CA and requires up to 20% domestic and international travel. Minimum on-site presence of 2 days per week is required.
REQUIREMENTS:
- Bachelor's degree in a scientific discipline (required); Advanced degree (Masters, PharmD, or PhD) preferred
- At least 12 years' experience in Regulatory Affairs in Pharma/Biotech
- Minimum 3 years direct leadership experience
- Experience in Oncology therapeutic area strongly preferred
- Strong negotiation skills with health authorities (FDA, EMA, Health Canada, etc.) and experience with submissions from IND/CTx through NDA/BLA or Marketing Applications
- Experience with development and execution of regulatory strategies in Oncology strongly preferred
- Ability to work in fast-paced environment in hands-on fashion
- Excellent oral, written, and presentation skills with experience presenting to leadership teams
- Demonstrated proficiency in organizational awareness and cross-functional collaboration on global teams
- Excellent planning and organizational skills; ability to manage multiple projects with tight timelines
- Experience in all phases of development highly preferred
- Strong understanding of regulatory operational activities
- Self-starter, flexible, proactive, and team player
- Ability to manage multiple projects and adapt to changing business needs and priorities
