Associate Director, Clinical Science

Olema Pharmaceuticals•San Francisco, CA

62d•$200,000 - $215,000•Hybrid

About The Position

As the 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-including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory, and Program Management-to plan, conduct, and analyze clinical trials. Your job contributes to and supports Olema's mission of developing therapies that offer the potential to improve outcomes for women living with cancer. This role may be based out of our San Francisco, CA or Cambridge, MA office and will require up to 15% travel.

Requirements

Advanced degree such as a PhD or PharmD; equivalent combination of relevant education and experience may also be considered
Experience in oncology clinical development is required
Ability to interact effectively within a cross-functional team
5-7+ years' experience working as a clinical scientist in the biotech/pharmaceutical industry
Comprehensive knowledge of oncology clinical trial implementation and drug development process
Demonstrated understanding of the clinical drug development process to execute drug development strategic plans and meet milestones
Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
Ability to proactively identify challenges/problems and propose solutions with a strong sense of urgency
Demonstrated success motivating both internal and external team members and collaborators, fostering and nurturing teamwork
Strong attention to detail
Excellent written and oral communication skills
Ability to work in a diverse and dynamic cross-functional team
Passionate about the drug-development process
Self-starter who thrives in a fast-paced environment

Responsibilities

Assisting in writing clinical documents including protocols, amendments, investigator's brochures, clinical study report (CSR), and the clinical sections of regulatory documents
Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopsis and protocols
Participating in ongoing clinical data review in collaboration with a cross functional team
Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety
Contributing to the writing and/or review product specific abstracts, publications and supporting the 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, investigator meetings and other study related activities
Ensuring adherence to Olema's Standard Operation Procedures and values, and maintaining the highest level of ethical behavior by leading by example
Maintaining clinical and technical expertise in the therapeutic area of oncology
Attending scientific meetings pertinent to clinical science activities