[Hiring] Senior Medical Director, Gastroenterology @Apogee Therapeutics

Role Description

We are seeking a Sr. Medical Director to lead the EoE (eosinophilic esophagitis) clinical development program. In this newly created role, you will serve as the EoE subject matter expert, overseeing clinical execution and medical monitoring of EoE studies. You will be responsible for seamless execution of trials and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitoring activities. If you thrive in a fast-paced environment and seek the opportunity to advance new clinical programs into later stages of development, this role is for you!

Key Responsibilities

• Participate in the design and execution of clinical studies in a new therapeutic area (Gastroenterology)
• Contribute clinical and strategic perspective to EoE development program through BLA
• Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution, including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
• Contribute to the design of trials, and develop protocols and other relevant documents for individual studies
• Lead study start-up activities
• Direct day-to-day clinical and medical execution of studies
• Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
• Partner with clinical operations on site selection, recruitment, and CRO management
• Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards and Investigator Meetings
• Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

Qualifications

• Education – MD is required
• Board certification in Gastroenterology a plus (not required)
• 4+ industry experience as a medical monitor and/or medical director
• Experience working on phase 2 and 3 clinical studies in Gastroenterology or related immunological conditions
• Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others
• Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Requirements

• Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year and functional meetings, study-related activities, and medical conferences.
• Intermittent travel to the Apogee office in San Francisco may be required.

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve