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Salary: USD 230,000 - 250,000 / annual
Olema Oncology is a clinical-stage biopharmaceutical company developing innovative therapies for breast cancer and other oncology indications. 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. A follow-on candidate, OP-3136, is a potent KAT6 inhibitor in development for metastatic breast cancer and prostate cancer.
As Director of Global Regulatory Affairs Strategy, you will lead the development and execution of innovative regulatory strategies supporting Olema's product portfolio. Reporting to the Senior Director of Regulatory Affairs, you will serve as the regulatory subject matter expert across cross-functional teams and the Executive Committee, providing strategic and tactical guidance on regulatory submissions (INDs, CTAs, briefing documents, IBs, NDAs, BLAs, DMFs, IMPDs, etc.).
Key responsibilities include:
- Provide regulatory leadership to the lead asset's clinical studies and develop global registrational strategies
- With minimal supervision, develop innovative global regulatory strategies for the Olema portfolio in clinical development and life-cycle management
- Represent Regulatory Affairs on cross-functional teams as SME, providing guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee
- Stay current with the regulatory landscape and requirements impacting drugs, biologics, and devices
- Lead development of regulatory submissions with minimal supervision
- Represent Olema with global health authorities and lead agency interactions to achieve company objectives
- Identify gaps and develop risk mitigation strategies for regulatory submissions
- Ensure Olema's regulatory activities are robust and compliant with health authority requirements
- Coordinate and maintain all 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 and the organization informed of the regulatory landscape, including health authority initiatives and impact on Olema's programs
- Lead the global regulatory team(s) and ensure execution of regulatory strategies to achieve company objectives
- Mentor and develop other regulatory colleagues in the department
- Support senior leadership of Regulatory Affairs as required
The role is based in either the Boston, MA or San Francisco, CA office and requires domestic and international travel up to 20%. On-site presence is required a minimum of 2 days per week.
QUALIFICATIONS:
- Bachelor's degree in a scientific discipline (required)
- 10+ years of regulatory affairs experience in the pharmaceutical/biopharmaceutical industry (required)
- Demonstrated experience leading regulatory strategy development for drug and/or biologic programs from IND through NDA/BLA submission and approval (required)
- Strong knowledge of FDA and international regulatory requirements and guidelines
- Experience with global regulatory submissions and health authority interactions
- Excellent written and verbal communication skills
- Strong project management and organizational skills
- Ability to work independently with minimal supervision
- Flexible and proactive, with ability to manage multiple projects and adapt to changing business needs
- Team player mentality
- Preferred: Experience in oncology drug development
