Director, Clinical Science

About the role

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.

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

Requirements

• A minimum of 8 years’ experience in biotech/pharmaceutical industry
• Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
• 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
• Advanced degree such as a PhD or PharmD 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

Qualifications

• 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

Skills

• Expertise in oncology clinical development
• Technical and clinical document writing
• Safety event tracking and management
• Collaboration with cross-functional teams
• Study level and individual subject level data analysis
• Product specific abstracts and publication development
• Regulatory compliance and guideline adherence

Benefits

Not specified

Pay

$220,000 - $245,000 annually

Schedule

Not specified