Sr. Medical Director, Clinical Development - Respiratory
We are seeking an experienced Sr. Medical Director to contribute to the strategy and oversee the clinical and medical execution of the respiratory programs. The individual will be responsible for driving study design, path to registration, and seamless execution of studies, supporting the VP of Clinical Development and the Clinical Development team. For candidates with prior management experience, you will oversee a small team (Medical Director and Clinical Scientist).
Key Responsibilities
- Contribute to the clinical development plan from proof-of-concept studies through BLA
- Lead study design
- Oversee day-to-day clinical and medical execution of studies, supporting medical monitors, working closely with the CRO, clinical operations and pharmacovigilance on study execution including safety reporting
- 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 and KOLs
- 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, training in pulmonology and/or allergy strongly preferred
- At least 3 years industry experience as medical monitor and/or medical director, working in clinical development
- Respiratory clinical development experience is required, experience in other inflammatory and immunological therapeutic areas a plus
- Knowledge of all phases of drug development, particularly phase 2 and beyond clinical development
- Experience leading and managing teams 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
- 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
- Position requires up to 20% travel including multiple offsite meetings, congresses, and ad boards throughout the year
The anticipated base salary range for candidates for this role will be $320,000 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.
- 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
Apply for this job
*
indicates a required field