Director, Clinical Science

Olema Oncology•San Francisco, CA

19h•$220,000 - $245,000•Hybrid

About The Position

As the Director, Clinical Science reporting to the Vice President, Clinical Science, you will play a key role in one of our ongoing clinical studies. You will work collaboratively in a multi-disciplinary team setting including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory and Program Management, in the planning, conduct and analysis of 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 is based out of our San Francisco, CA or Cambridge, MA office and will require up to 20% travel.

Requirements

Advanced degree such as a PhD or PharmD is required
Experience in oncology clinical development is required
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
A minimum of 8 years’ experience in biotech/pharmaceutical industry is required
Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines
Proactively identifying challenges/problems and proposing 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
Ability to interact effectively within a cross functional team
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

Nice To Haves

familiarity with other international regulatory requirements is a plus

Responsibilities

Writing of technical and clinical documents including protocols, amendments, investigator’s brochures, and the clinical sections of regulatory documents
Working with the study team to identify and track any potential safety events within a given trial
Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols
Evaluate the safety, pharmacology, and efficacy of ongoing studies in close collaboration with the medical monitor and the safety, pharmacology and clinical operations teams
Organizing and performing the study level and individual subject level analysis of the clinical trial data to gain insights and develop strategies for the clinical study report (CSR) writing
Contributing to the writing and/or review product specific abstracts, publications and supporting the development of presentations for scientific meetings
Maintaining clinical and technical expertise in the therapeutic area of oncology
Attending scientific meetings pertinent to clinical science activities
Collaborating with the Medical Monitor on review of enrollment packets, clinical development plans and scientific presentations
Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions
Participating in ongoing clinical data review in collaboration with a cross functional team
Collaborating with Clinical Operations and other team members in the development of agendas, training materials and presentation 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