Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Overview

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

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

As the

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

reporting to the Senior Vice President of Regulatory Affairs, your responsibilities will include the following :

Lead the development of the New Drug Application (NDA)

Lead the development and execution of innovative regulatory strategies supporting Olema products

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

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 either our

Boston, MA

or

San Francisco, CA

office and will require domestic and international travel up to 20%.

Responsibilities

Your work will primarily encompass :

Lead the development and submission of the NDA for the company's lead program

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 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 :

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 SVP Regulatory Affairs, as required

Ideal Candidate Profile

Innovative Experienced Regulatory Strategy Leader

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 with development and execution of regulatory strategies in Oncology Therapeutic area is strongly preferred

Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices

Experience with major regulatory submissions (e.g. New Drug Applications (NDA / NDS / MAA), is a must

Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required

Ability to work in a fast-paced environment in a hands-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 and post marketing activities is highly preferred

Demonstrated ability to analyze and interpret efficacy and safety data

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 at the headquarter is required (minimum 2 days a week)

The base pay range for this position is expected to be

$275,000-$290,000

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.

Please note : Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com ; our careers page isolema.com / careers ; our LinkedIn page islinkedin.com / company / olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message / messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.

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