Director, Global Regulatory Affairs - Strategy Lead

Director, Global Regulatory Affairs - Strategy Lead

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully integrated oncology company well underway, it’s an exciting time to be part of Team Olema.

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in Q1 2027 which, if positive, could lead to our first potential approval and commercial launch in 2028. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant could transform the metastatic breast cancer treatment paradigm and provide access to a $15 billion global market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently presented encouraging Phase 1 monotherapy data from this program across multiple solid tumor types, are advancing patient enrollment in the ongoing combination arms in MBC, and expect to initiate a Phase 1 study of OP-3136 in combination with Bayer’s darolutamide in metastatic castration-resistant prostate cancer by the end of this year.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and passionate colleagues dedicated to helping the patients we serve feel better, longer. Team Olema possesses a deep commitment to a shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, the drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. We are a small group of nimble self-starters who bring consistency in our quest for the extraordinary every single day.

If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond.

About the Role

As the Director, Global Regulatory Strategy Lead - Regulatory Affairs reporting to the Senior Director of Regulatory Affairs, you will lead the development and execution of innovative regulatory strategies supporting Olema products . You will also represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive Committee. You will provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)

This role is based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%.

Your work will primarily encompass:

• Provide regulatory leadership to the lead asset’s clinical studies and lead the development of global registrational strategies
• With minimal supervision, develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed
• Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive committee
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices
• Provide strategic and tactical guidance and with minimal supervision lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)
• Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives
• Identify gaps and develop risk mitigation strategies for the regulatory submissions
• Ensure Olema’s regulatory activities are robust and are in compliance with Health Authority (HA) regulatory requirements
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams
• Be flexible to adapt and accommodate additional duties as assigned

And will also include the following:

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives and impact on Olema’s programs
• Lead the global regulatory team(s) and ensure execution of the Regulatory strategies to achieve the company objectives
• Mentor and develop other regulatory colleagues in the department
• Support the senior leadership of Regulatory Affairs, as required

Ideal Candidate Profile Innovative Experienced Regulatory Strategy Leader

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role.

Knowledge:

• Bachelor’s degree in a scientific discipline
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred

Experience:

• At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech
• Minimum of 3 years direct leadership experience
• Experience in Oncology Therapeutic area is strongly preferred
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions (IND/CTx to NDA/BLA or Marketing Applications)
• Experience with development and execution of regulatory strategies in Oncology TA is strongly p referred
• Ability to work in a fast‑on fashion
• Excellent oral, written, and presentation skills, with experience presenting to the leadership teams
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines
• Experience in all phases of development is highly preferred
• Strong understanding of regulatory operational activities

Attributes:

• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities
• Team Player
• On site presence is required (minimum 2 days a week)

The base pay range for this position is expected to be $230,000 - $250,000 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.

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.