Associate Director, Clinical Science

Role Summary

Associate Director, Clinical Science role reporting to the Director, Clinical Science. You will be part of a multidisciplinary team to plan, conduct, and analyze clinical trials in ongoing studies, contributing to Olema’s mission 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’s brochures, clinical study reports, and the clinical sections of regulatory documents
• Interacting with investigators and thought leaders in oncology 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 related to protocol conduct and subject safety
• Contributing to writing and/or reviewing product-specific abstracts, publications, and supporting development of presentations for scientific meetings
• Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms, and CRF instructions
• Collaborating with Clinical Operations and other team members to develop agendas, training materials, and presentations for site visits and investigator meetings
• Ensuring adherence to Olema’s SOPs and values, maintaining high ethical standards
• Maintaining clinical and technical expertise in oncology
• Attending scientific meetings pertinent to clinical science activities

Qualifications

• Knowledge:
  • Advanced degree such as a PhD or PharmD; equivalent experience may be considered
  • Experience in oncology clinical development is required
  • Ability to interact effectively within a cross-functional team
• Experience:
  • Minimum 5-7+ years’ experience as a clinical scientist in biotech/pharmaceutical industry
  • Comprehensive knowledge of oncology clinical trial implementation and drug development process
  • Understanding of the clinical drug development process to execute strategic plans and meet milestones
  • Strong knowledge of GCP, FDA, and EMEA/CHMP regulations; familiarity with other international regulatory requirements is a plus
  • Ability to identify challenges and propose urgent solutions
  • Demonstrated success motivating internal and external team members and collaborators
• Attributes:
  • Strong attention to detail
  • Excellent written and oral communication skills
  • Ability to work in a diverse, dynamic cross-functional team
  • Passionate about the drug-development process
  • Self-starter in a fast-paced environment

Skills

• Clinical trial design and implementation
• Scientific communication and publications
• Cross-functional collaboration
• Regulatory knowledge (GCP, FDA, EMEA/CHMP)

Education

• PhD or PharmD or equivalent experience

Additional Requirements

• Travel up to 15% as needed