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Senior Medical Director, Respiratory
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, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.
If this sounds like you, keep reading!
Role Summary
We are seeking a Sr. Medical Director to oversee the clinical and medical execution of studies. The individual will be responsible for seamless execution of studies and support the VP of Clinical Development and the Clinical Development team in developing the clinical strategy with a focus on protocol development and study execution for respiratory indications.
Key Responsibilities
- Oversee day-to-day clinical and medical execution of studies
- Serve as medical monitor, working closely with the CRO, clinical operations and pharmacovigilance on study execution including safety reporting
- Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents
- 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
- Build and maintain strong relationships with PIs
- Serve as primary point of contact for sites and PIs
- Support development of the overall clinical strategy for the company
- Support design of trials and develop protocols for individual studies
Ideal Candidate
- MD required
- 2-5 years clinical development experience gained working in industry as a medical monitor and/or medical director
- Proven experience in respiratory drug development, designing and managing clinical trials (Phase II, and Phase III), through investigator and regulatory interactions is preferred
- Emerging leader with a growth mindset, willing to mentor as well as learn from others
- Experience as the clinical development representative on cross functional drug development teams
- Knowledge of all phases of drug development, from early clinical development through later stage
- Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
- Experience filing Investigational New Drug applications and/or Biologics License Applications
- Ability to travel approximately 20% to All Team meetings, functional meetings, ad boards, and study-related activities.
The anticipated salary range for candidates for this role will be $325,000 to $350,000 / 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
- Flexible PTO
- Two, one-week company-wide shutdowns each year
- 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.
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