Medical Director, Clinical Development – Immunology

Apogee Therapeutics • Full-time • Remote (United States) • $270k - $310k / year • 9h ago

About the job

About Apogee Therapeutics

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 Medical Director to support clinical execution and medical monitoring of dermatology/immunology studies. As part of a growing clinical development team, you will be responsible for seamless execution of studies and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitor activities. This position will work closely with senior clinical leaders and clinical scientists. If you thrive in a fast-paced environment and seek the opportunity to advance clinical programs into later stages of development this role is for you!

Key Responsibilities

Serve as a primary Sponsor medical representative for assigned clinical trial, working closely with the CRO medical monitor and cross-functional partners, and pharmacovigilance on study execution including but not limited to safety reporting, escalation for medical issues, development and execution of the Medical Monitoring Plan
Contribute to protocol development, study documents, operational plans, and other relevant documents for individual studies
Support all the start-up activities related to the assigned clinical study including investigator training, vendor discussions, cross-functional team reviews
Oversee day-to-day clinical and medical execution of studies including direct medical review of eligibility, safety events, and clinical data
Work closely with cross-functional colleagues, including, but not limited to regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan and study milestones in alignment with business goals
Partner with clinical operations on site selection, recruitment, site relationship management and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs by participating in KOL interactions and scientific engagement activities

Ideal Candidate

Education – MD is required
Experience in clinical development and/or study design and execution within Immunology & Inflammation therapeutic areas, ideally dermatology, allergy, or rheumatology
2+ years’ pharma/biotech clinical development or medical affairs with study execution experience preferred
Experience working on phase 2 and 3 clinical studies strongly preferred
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 approximately 30% including mandatory in-person attendance at All Team meetings typically held twice per year. Travel will also be required to attend functional meetings, study-related activities, and medical conferences.

The anticipated salary range for candidates for this role will be $270,000 – $310,000 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.

What We Offer

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

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Apply