Role Summary

We are seeking a Therapeutic Area (TA) Head, Respiratory - Clinical Development. In this newly created position, you will be primarily responsible for developing and executing an integrated clinical development strategy and clinical trial programs in respiratory. In this leadership role, you will have the opportunity to guide and mentor a team of experienced Medical Directors and Clinical Scientists.

As part of a growing Clinical Development organization, you will be responsible for providing clinical expertise, obtaining scientific advisory input from external experts, working cross-functionally to develop clinical studies, leading clinical aspects of regulatory interactions for product advancement, and partnering with the clinical operations team to provide medical and strategic input to achieve operational excellence. The TA Head will have expertise in respiratory disease, have demonstrated effective collaborative skills to work across various phases of clinical development with an emphasis on later stages (phase 2 and beyond), and serve as a medical expert for multiple cross functional teams. Building relationships with Investigators is essential for this role including meeting with sites to foster collaboration and training. Apogee offers a dynamic, fast paced and highly collaborative approach to drug development. The Therapeutic Area Head will oversee programs across the respiratory portfolio. The position reports to the SVP, Head of Clinical Development.

Key Responsibilities

• Build, lead and mentor a team of Medical Directors and Clinical Scientists focused on Apogee’s respiratory portfolio, including monotherapy and combination therapies
• Apply expertise in the treatment and management of respiratory conditions to advance the strategy and clinical development of Apogee’s medicines for the benefit of our patients
• Work cross-functionally with Program Leadership/Management, Biometrics, Medical Affairs, Clinical Pharmacology, Regulatory Affairs, Research & Translational Medicine, Commercial and other functions to develop the overall clinical development strategy in respiratory indications
• Collaborate with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to execute and successfully complete clinical trials across development phases leading to BLA filings and approvals
• Help establish and maintain a network and relationships with respiratory experts, investigators and opinion leaders
• Contribute to the scientific communication strategy of Apogee Therapeutics via publications, manuscripts, abstracts, posters and scientific presentations
• Participate in medical review of adverse event reports and monitoring of incoming safety data in collaboration with pharmacovigilance, including evaluating and escalating safety signals
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA and government, regulatory, or partner agencies
• Present to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and key opinion leaders
• Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
• Review and edit clinical study reports

Ideal Candidate

• Board certified MD with expertise in respiratory and/or immunology drug development and experience across later stages of clinical development
• 10+ years' biotech or pharmaceutical industry experience in a leadership role building and mentoring clinical development teams (MDs and non-MDs)
• Passion for bringing better treatment options to patients and caregivers
• Knowledge of clinical development strategies and trial execution for biologics and immunology therapeutics in the US and globally
• Self-starter who will bring expertise and inspiration to the team, is able to multi-task in support of clinical development programs and has a growth mindset
• Leads and works collaboratively with cross-functional teams in a fast-paced, hands-on and dynamic environment
• Strong leadership, communication and presentation skills
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires approximately 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, as well as team meetings, medical conferences, etc.

The anticipated salary range for candidates for this role will be $395,000 to $425,000 / 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.