Senior Director, Global Regulatory Strategy

Olema Oncology•San Francisco, CA

1d•Hybrid

About The Position

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential. Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond. As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following: Leading the development and execution of innovative regulatory strategies supporting Olema products. Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams. Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.). This role is based either 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: Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed. Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/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 (e.g., companion diagnostics). Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.). Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives. Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management. Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements. Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams. Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc). Participate in and contribute to cross-functional and departmental objectives. Maintain flexibility 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, policies and their potential impact on Olema’s programs. Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives. Mentor and develop colleagues in the Regulatory department.

Requirements

12 years’ experience in Regulatory Affairs in Pharma/Biotech
Minimum of 3 years direct leadership experience
Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions
Experience in Oncology Therapeutic area is required
Experience with development and execution of regulatory strategies in Oncology TA is required
Ability to work in a fast-paced environment in a hands-on fashion
Excellent oral, written, and presentation skills
Strong organizational skills

Nice To Haves

Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred
Experience with leading the NDA/BLA or Marketing Applications is desirable.

Responsibilities

Leading the development and execution of innovative regulatory strategies supporting Olema products
Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)
Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed
Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/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 (e.g., companion diagnostics)
Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)
Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives
Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management
Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements
Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams
Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)
Participate in and contribute to cross-functional and departmental objectives
Maintain flexibility to adapt and accommodate additional duties as assigned
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, policies and their potential impact on Olema’s programs
Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives
Mentor and develop colleagues in the Regulatory department