Associate Director, Clinical Science

Role Summary

Associate Director, Clinical Science role at Olema Oncology with responsibility within ongoing clinical studies, collaborating across multi-disciplinary teams to plan, conduct, and analyze clinical trials. Based in San Francisco, CA or Cambridge, MA with up to 15% travel.

Responsibilities

• Assisting in writing clinical documents including protocols, amendments, investigator’s brochures, CSR, and regulatory clinical sections
• Interacting with investigators and thought leaders to design clinical synopsis and protocols
• Participating in ongoing clinical data review with cross-functional teams
• Ensuring trial implementation per protocol and analyzing information to assess conduct and subject safety
• Contributing to writing/review of product abstracts, publications, and developing presentations for scientific meetings
• Collaborating to develop Informed Consent Forms, Case Report Forms, and CRF instructions
• Developing agendas, training materials, and presentations for site visits and investigator meetings
• Ensuring adherence to Standard Operating Procedures and upholding ethical behavior
• Maintaining clinical and technical expertise in oncology
• Attending scientific meetings relevant to clinical science activities

Qualifications

• Knowledge: Advanced degree such as PhD or PharmD; oncology clinical development experience required; ability to interact effectively within a cross-functional team
• Experience: 5-7+ years as a clinical scientist in biotech/pharmaceutical industry; comprehensive knowledge of oncology trial implementation and drug development; understanding of clinical drug development processes and milestones; strong knowledge of GCP, FDA, and EMEA/CHMP regulations; ability to identify challenges and propose solutions; demonstrated teamwork and leadership
• Attributes: Strong attention to detail; excellent written and oral communication; ability to work in a diverse, dynamic cross-functional team; passion for drug development; self-starter in a fast-paced environment

Skills

• Clinical trial design and protocol development
• Regulatory documentation and pharmacovigilance understanding
• Cross-functional collaboration and stakeholder management
• Scientific writing and presentations for meetings
• Data review and safety assessment

Education

• PhD or PharmD (or equivalent combination of education and experience)

Additional Requirements

• Travel up to 15% as needed