Associate Director, Clinical Science

About the Role >>> Associate Director, Clinical Science

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.

Your work will primarily encompass:

• 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

And will also include:

• 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

Ideal Candidate Profile >>> Self-Motivated Clinical Scientist

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• 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

Experience:

• 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

Attributes:

• 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

The base pay range for this position is expected to be $200,000 - $215,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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