Director, Formulation Development

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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

As the Director, Formulation Development reporting to the Sr. Director of CMC Drug Product Development, you will lead pre-formulation, formulation development, tech transfer, scale-up, manufacturing, registration, design of experiments, process performance qualification and commercialization. This role provides scientific expertise in solid oral dosage formulation development, early to late-stage process development, oversight of GMP drug product manufacturing at contract development sites, authoring global regulatory filings (INDs, IMPDs, NDA, MAA, etc.) and technical oversight of preclinical and clinical formulation development effort. This position will collaborate with cross functional departments and other CMC functions in a fast-paced high growth environment team to ensure progression of Olema small molecules from discovery through development / commercialization.

This role is based out of our San Francisco office and will require 10-25% travel (domestic and International).

Your work will primarily encompass :

• Lead preclinical and early clinical phase formulation development efforts at CMO and provide oversight of tech transfer to GMP vendor for scale up and clinical drug product manufacturing.
• Design and provide oversight for development and characterization studies in evaluating formulation development and drug product unit process feasibility.
• Work closely with CMOs to address and refine formulation and process-related challenges over the entire course of clinical drug product development.
• Develop strategies and execution plans for drug product development from first human dosage through development of NDA-ready formulations in accordance with timelines and requirements of overall development programs.
• Work closely with clinical supply team to ensure uninterrupted drug product supply for ongoing studies and strategically risk-mitigate any supply constraints.
• Work closely with project management to align on study timeline and corresponding drug product supply plan to adequately secure GMP production slots at CDMOs.
• Work closely with project management to identify critical CMC decision points, gain alignment at Program Team (PT) level and final endorsement from Executive Commitment (EC).
• Work closely with Olema regulatory CMC team (or consultants) to align on filing strategies, including clearing regulatory responsibilities to provide drug product for studies.
• Engage in identifying high quality drug product manufacture CMOs or CDMOs in expertise, capability and capacity for effective collaboration in developing and / or commercializing Olema molecule.
• Lead formulation and process development, technology transfer, scale-up, and clinical manufacturing activities at CDMOs.
• Review and approve manufacturing documents, protocols and reports.
• Lead manufacturing and quality function to resolve technical issues and address deviation investigations.
• Lead the design of experiments (DoE) studies to evaluate formulations and process parameters at CDMOs to support NDA filing.
• Lead the late-stage process development and optimization activities to identify CPPs, CQAs etc. leading to process performance qualification and commercialization.
• Lead strategy development and execution of packaging validation at CDMOs as part of commercialization.
• Lead CMC drug product sections authoring in regulatory submissions for NDA / MAA filing.

Ideal Candidate Profile

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 :

Experience :

Attributes :

The base pay range for this position is expected to be $220,000-$230,000 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.

Important Information

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.

Additional Note / Fraud Alert : Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema. #J-18808-Ljbffr

Salary : $220,000 - $230,000