Sr. Medical Director, Gastroenterology
TLDR
Lead the eosinophilic esophagitis clinical development program, serving as the subject matter expert and overseeing execution of trials in a fast-paced, dynamic biotech environment.
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
If this sounds like you, keep reading!
Role Summary
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
Ideal Candidate
- 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
- 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.
The anticipated salary range for candidates for this role will be $350,000 to $375,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
- 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
Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics designed to deliver differentiated efficacy and dosing in the expansive immune and inflammatory (I&I) markets. We cater to patients and healthcare providers seeking innovative treatment options that can address unmet medical needs.