Senior Medical Director, Clinical Development

This is a fully remote position, open to applicants in California.

📋 Description

• Lead and manage clinical trials at both early and late stages for oncology products currently in development.

• Contribute to the design and planning of clinical studies while interpreting the results of those studies.

• Establish and validate scientific methodologies for clinical protocol design, data collection systems, and final reports.

• Recruit clinical investigators for research studies as necessary.

• Oversee adverse event reporting and monitor safety events.

• Organize and generate reporting information for FDA submissions.

• Ensure adherence to protocols and assess study completion.

• Support clinical trial strategies for oncology products.

• Design, prepare, and initiate study protocols and necessary documentation in accordance with project plans, federal regulations, GCP, and good medical practices.

• Serve as the medical monitor for company-sponsored trials, covering eligibility and safety-event assessments, data reviews, protocol writings, investigator and committee presentations, DMC reviews, clinical study reports, and publication reviews.

• Provide project teams with specialized information pertinent to therapeutic areas.

• Collaborate with the internal safety team to analyze and report safety data from clinical trials.

• Analyze and interpret clinical trial data, preparing reports for regulatory agencies and publication purposes.

• Engage with key opinion leaders and investigators in relevant disease-specific fields.

• Ensure alignment of scientific and development strategies.

• Maintain a high standard of scientific and clinical knowledge in the pertinent disease-specific area.

• Directly supervise team members.

⛳️ Requirements

• MD with a minimum of 8 years of relevant post-residency experience, or a suitable combination of education and experience.

• Board certification or eligibility in Oncology or Hematology/Oncology is preferred but not mandatory.

• At least eight years of experience in drug development within the biotechnology or pharmaceutical industry, or a combination of academic and industry experience.

• Practical experience in the design, execution, medical monitoring, and reporting of controlled clinical trials in oncology.

• Involvement in clinical oncology studies utilizing molecular targeted or immunological therapies.

• Knowledge of basic scientific principles related to clinical oncology, including biochemistry, immunology, molecular biology, and/or genetics.

• Ability to function effectively in a cross-functional or matrix environment.

• Extensive expertise or unique skills that support company objectives.

• Capability to devise technical and/or business solutions for complex challenges.

• Ability to recognize and implement methods, techniques, procedures, and evaluation criteria.

• Experience in leading or managing the work of others.

• Proficiency in developing and sustaining relationships with key opinion leaders.

• Strong written and verbal communication, influencing, and presentation skills.

• Excellent organizational and time management abilities.

🏝️ Benefits

• 401k plan featuring generous company contributions.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance benefits.

• Flexible spending accounts available.

• Discretionary annual bonus program.

• Opportunity to acquire company stock.

• Long-term incentives offered.

• 15 accrued vacation days in the initial year.

• 17 paid holidays, including a company-wide winter shutdown in December.

• Up to 10 sick days per calendar year.

• Provision of necessary equipment, such as dual monitors and ergonomic chairs.