Therapeutic Area Head – Respiratory
New
A
Apogee TherapeuticsBiotechnology
Location: RemoteFull-TimeManager
Salary395,000 - 425,000 USD per year
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Job Details
- Experience
- 10+ years' biotech or pharmaceutical industry experience
- Required Skills
- Leadership
Requirements
- Board certified MD
- Expertise in respiratory and/or immunology drug development
- Experience across later stages of clinical development (Phase 2 and beyond)
- 10+ years of biotech or pharmaceutical industry experience
- Proven experience building and mentoring clinical development teams
- Knowledge of clinical development strategies for biologics
- Understanding of trial execution in the US and globally
- Strong leadership skills
- Excellent communication and presentation skills
- Ability to work collaboratively in a fast-paced environment
Responsibilities
- Build, lead and mentor a team of Medical Directors and Clinical Scientists focused on Apogee’s respiratory portfolio.
- Develop and execute integrated clinical development strategy and clinical trial programs in respiratory.
- Provide clinical expertise and obtain scientific advisory input from external experts.
- Lead clinical aspects of regulatory interactions and partner with clinical operations.
- Collaborate cross-functionally with Biometrics, Medical Affairs, Regulatory, and Commercial teams.
- Establish and maintain a network of respiratory experts, investigators, and opinion leaders.
- Contribute to scientific communication strategy via publications, manuscripts, and presentations.
- Participate in medical review of adverse event reports and safety data monitoring.
- Coordinate reports for FDA, EMA, PMDA and other regulatory agencies.
- Review and edit clinical study reports.
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