Director, Analytical Development

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
.

You can view our latest corporate deck and other presentations here.

Director, Analytical Development

As the Director of Analytical Development reporting to the Senior Director, Analytical Chemistry, you will be responsible for driving progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation. You will drive method innovation, ensure alignment with regulatory expectations, and partner cross-functionally to support process development, formulation, CMC, and quality activities. In this role, you will bring deep technical expertise, proven leadership, and the ability to operate effectively in a fast-paced, growth-stage biotech environment.

This role is based out of either our San Francisco or Boston offices and will require 10% travel.

Your work will primarily encompass:

• Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
• Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
• Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
• Manage stability programs, monitor trending stability data and establish re-test periods or shelf lives for drug substances or drug products
• Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
• Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions
• Represent Analytical Chemistry at internal and external scientific team meetings as needed
• Remain current with state-of-the‑art approaches and applicable global regulations and industry standards

• PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late-stage clinical development and preparation for product registration
• Minimum of 5 years direct leadership experience on managing internal and external teams
• Expertise of cGMP, ICH, and FDA regulations/guidance
• Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
• Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones
• Experience in partnering with cross‑functional teams providing analytical development leadership across programs and projects
• Demonstrated interpersonal skills, including strong oral and written communication abilities

• A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this role
• Aspires to the highest of scientific and ethical standards
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Keen to improve processes and overcome inefficiencies

The base pay range for this position is expected to be $215…