JOB SUMMARY
Iambic Therapeutics is seeking an Associate Medical Director or Medical Director to join its growing Clinical Development team. This position will be responsible for study execution and oversight of a clinical program currently in phase 1, as well as supporting pipeline programs that are in the preparation phase for IND submission. In addition to providing medical oversight for the phase 1 clinical trial, ensuring patient safety, regulatory compliance and scientific integrity, this individual will also contribute to the clinical program strategy and execution.
KEY RESPONSIBILITIES
- Serve as the medical monitor for assigned clinical trials, providing medical and scientific expertise throughout the study lifecycle.
- 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
- Ensure participant safety by reviewing adverse events (AEs), serious adverse events (SAEs) and protocol deviations collaborate with pharmacovigilance to assess safety signals across the study
- Provide guidance on patient eligibility and protocol adherence
- Contribute to preparation of study-related documents including study protocols and amendments, Investigator Brochures (IBs), informed consent forms (ICFs), and clinical study reports (CSRs)
- Review and interpret clinical trial data, ensuring accuracy and consistency in the safety, efficacy and other data
- Support interactions with regulatory agencies, including preparation of documents for submission and participation at regulatory meetings
- 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
QUALIFICATIONS
- MD or PharmD with clinical oncology experience as well as experience in biotech/pharma oncology drug development is preferred. PhD with a minimum of 3 years of biotech or pharmaceutical experience in oncology drug development.
- Experience as a medical monitor on a clinical trial, including patient eligibility review, site interaction to oversee protocol adherence, protocol deviation review, clinical data review and cleaning activities, coding
- Experience in executing on clinical studies, including interactions with regulatory agencies
- 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
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
