Director, Analytical Development

Olema Oncology is a biotech company dedicated to developing better medicines for breast cancer and beyond. The Director, Analytical Development role is responsible for driving progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation.

Requirements

• 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
• 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
• 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

Benefits

• Competitive compensation and benefits package
• Equity, bonus, and benefits