Therapeutic Area Head - Respiratory

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 expe

Additional Information

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: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at "good enough". If this sounds like you, keep reading! 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.

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