Senior Medical Director, Clinical Development

About the Role >>> Medical Director

As the Medical Director of Clinical Development reporting to the VP of Clinical Development, you’ll play an instrumental role in guiding the successful clinical development efforts for OP-1250 as the oncology physician lead.

Collaborating with project teams, you’ll plan, design, and execute clinical development research studies to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of OP-1250 programs and future therapies.

This role may be based in the San Francisco or Boston office, and will require up to 20% travel.

Your work will primarily encompass: 

Functioning as a Medical Expert 

• Serve as medical lead for clinical registration-enabling studies with OP-1250, including contributing to the design of studies, interacting with regulatory authorities and investigators, and starting up related medical/operational activities. 
• Provide consulting on the clinical perspective for various internal functions.
• Interface and lead interactions with investigators, academics, and thought leaders in a variety of settings including academic society meetings, advisory boards, and investigator meetings.
• Attend scientific meetings pertinent to clinical science activities.
• Maintain clinical and scientific awareness in area of expertise.

Designing and Executing the Studies 

• Develop related reports and resources, including additional clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts, and clinical study reports in collaboration with the clinical development team.
• Ensure data quality, summary, and writing of clinical study report in close collaboration with the clinical operations, biometrics, and CRO oversight teams.
• Evaluate the safety, pharmacology, and efficacy of ongoing and completed studies in close collaboration with the safety and clinical operations teams.
• Work on regulatory submission documents.
• Establish and implement exploratory pharmacodynamic, predictive, and prognostic biomarker plans in conjunction with pre-clinical scientists, consultants, and collaborators.
• Ensure adherence to Olema’s Standard Operation Procedures and values, maintaining the highest level of ethical behavior and leading by example.

Ideal Candidate Profile >>> Experienced Oncology Physician Lead

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: 

• MD degree or equivalent, with at least 2 years of experience in drug development required.
• Board certification in oncology is preferred (especially breast cancer specialty); strong experience in breast cancer oncology without board certification may also be considered.

Experience: 

• Designing, leading, and managing industry clinical studies in solid tumors strongly preferred; academic expert with breast cancer expertise and significant experience as PI in clinical research may also be considered.
• Demonstrated understanding of the drug development process evidenced by the ability to execute and deploy drug development strategic plans, to develop contingency plans, to provide technical and strategic advice, and to meet milestones and budgets.
• Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus.
• Effectively evaluating outside expert advice.
• Communicating and explaining oncologic technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
• Proactively identifying challenges/problems and proposing solutions with a strong sense of urgency.
• Presenting clearly using scientific and clinical terminology.
• Demonstrated success motivating both internal and external team members and collaborators, fostering and nurturing teamwork.

Attributes: 

• Excellent communicator who can represent the program and engage external business partners, academics, and regulatory bodies.
• Ability to work in a diverse and dynamic cross-functional team.
• Independent worker who can effectively head and participate in a team.

The base pay range for this position is expected to be $303,000 - $350,000 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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