Associate Medical Director/Medical Director

Job Description

Job Description

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.  The individual in this position will report to the Senior Medical Director.  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. This role is site-based or hybrid.

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

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

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 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 the equivalent, PharmD or PhD with a minimum of 3 years of biotech or pharmaceutical experience in oncology drug development.

Clinical oncology experience preferred.

ABOUT IAMBIC THERAPEUTICS

Founded in 2019 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.

MISSION & CORE VALUES

The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.

ALSO

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and unlimited 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.