Senior Medical Director - Respiratory

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Apogee Therapeutics

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Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.

Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• 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. • 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 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.

Requirements

• 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.

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 • 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