JOB SUMMARY
KEY RESPONSIBILITIES
- Provide clinical and medical expertise in strategic planning for clinical stage and IND ready pipeline programs
- Prepare clinical sections of relevant regulatory documents including INDs, study protocols, investigator brochures, clinical study reports, and briefing documents
- Provide medical oversight for clinical trials including medical monitoring, participation on safety review committees, and responding to questions from regulatory agencies, institutional review boards, and ethics committees
- Work closely with other functional areas within Research and Development (clinical operations, regulatory sciences, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials and ensure that high standards of study conduct are met
- Establish strategic partnerships with KOLs, centers of excellence, and patient advocacy organizations
- Develop content for advisory board meetings
- Prepare abstracts and presentations for scientific symposia and manuscripts for publication in high impact peer reviewed journals
- Keep up to date on standard of care and experimental therapies in relevant clinical areas through familiarity with literature, attendance at meetings, conventions and professional associations
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Experience in designing and executing on clinical studies, including interactions with regulatory agencies
- Expertise in the development of HER2 targeted treatments is highly desirable
- Excellent written and verbal communication skills
- Ability to work effectively in cross functional teams with internal and external partners
- Excellent organizational and time management skills with strong attention to detail, and proven ability to handle multiple tasks efficiently and effectively.
- Creative problem-solving skills with proven ability to act in a proactive manner
QUALIFICATIONS AND EXPERIENCE
- MD or equivalent, with a minimum of 3 years of biotech or pharmaceutical experience in oncology drug development. Oncology fellowship training and ABIM Oncology certification preferred.
Salary range: $204,030-$357,052