Therapeutic Area Head - Clinical Development - Dermatology

Summary

Join Apogee Therapeutics as their Therapeutic Area (TA) Head - Clinical Development, a newly created position leading the development and execution of clinical development strategies and trial programs in dermatology. You will mentor a team of Medical Directors and Clinical Scientists, providing clinical expertise and collaborating cross-functionally. Responsibilities include leading regulatory interactions, partnering with clinical operations, building relationships with investigators, and contributing to scientific communication. The ideal candidate is a board-certified MD with immunology/dermatology expertise, 10+ years of biotech/pharmaceutical experience, and a passion for improving patient care. The position offers a competitive compensation and benefits package, including base salary, performance bonus, equity, flexible PTO, and professional development opportunities. Apogee fosters a dynamic, collaborative environment and values its C.O.R.E. principles.

Requirements

• Board certified MD with expertise in immunology and/or dermatology product development and experience across later stages of clinical development
• 10+ years' biotech or pharmaceutical industry experience
• 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

Responsibilities

• Lead and mentor a team of experienced Medical Directors and Clinical Scientists focused on bringing innovative treatments to patients
• Apply expertise in the treatment and management of dermatological 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, Clinical Strategy Office, Biometrics, Medical Affairs, Clinical Pharmacology, Regulatory Affairs, Research & Translational Medicine, Commercial and other functions to develop the overall clinical development strategy in dermatologic 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 dermatology 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

Benefits

• 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