Associate Director, Clinical Science

Role Summary

Associate Director, Clinical Science. Reporting to the Director, Clinical Science, you will play a key role in one of our ongoing clinical studies. You will collaborate within a multi-disciplinary team to plan, conduct, and analyze clinical trials, contributing to Olema’s mission of developing therapies to improve outcomes for women living with cancer. This role may be based in San Francisco, CA or Cambridge, MA, with up to 15% travel.

Responsibilities

• Assisting in writing clinical documents including protocols, amendments, investigator‚Äôs brochures, clinical study reports (CSR), and clinical sections of regulatory documents
• Interacting with investigators and thought leaders to facilitate design of clinical synopsis and protocols
• Participating in ongoing clinical data review in collaboration with a cross-functional team
• Ensuring trial implementation according to the protocol and analyzing information to assess issues relating to protocol conduct and subject safety
• Contributing to writing and/or reviewing product-specific abstracts, publications, and supporting the development of presentations for scientific meetings
• Collaborating to develop Informed Consent Forms, Case Report Forms, and CRF instructions
• Collaborating to develop agendas, training materials, and presentations for site visits, investigator meetings, and other study-related activities
• Ensuring adherence to Olema‚Äôs SOPs and values, and maintaining ethical behavior
• Maintaining clinical and technical expertise in oncology
• Attending scientific meetings pertinent to clinical science activities

Qualifications

• Knowledge: Advanced degree such as PhD or PharmD; equivalent combination of relevant education and experience
• Experience: Minimum 5-7+ years as a clinical scientist in biotech/pharmaceutical industry; oncology clinical development experience required
• Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations; familiarity with other international regulatory requirements is a plus
• Ability to interact effectively within a cross-functional team
• Attributes: Strong attention to detail; excellent written and oral communication; ability to work in a diverse cross-functional team; passionate about drug development; self-starter in a fast-paced environment

Skills

• Cross-functional collaboration
• Clinical trial design and data interpretation
• Regulatory document development
• Scientific communication and presentations

Education

• PhD or PharmD preferred; relevant experience considered