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Senior Medical Director, Clinical Development Jobs

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Senior Medical Director, Clinical Development
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Lead clinical development for innovative cell therapies in autoimmune diseases at Cabaletta Bio. This hands-on Senior Medical Director role in Philadelphia requires an MD/PhD with 7+ years in biotech/pharma clinical trials. Provide medical oversight from early to late-stage studies, collaborating...
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United States , Philadelphia
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Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
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Until further notice
Pursue a pivotal leadership role at the forefront of medical innovation by exploring Senior Medical Director, Clinical Development jobs. This high-level executive position sits at the strategic and scientific heart of a biopharmaceutical or biotechnology company, responsible for the medical and scientific integrity of clinical programs from early-stage research through to regulatory submission and beyond. Professionals in this role are physician-scientists who translate promising laboratory discoveries into viable, evidence-based therapies for patients, shaping the future of medicine. The core mission of a Senior Medical Director is to provide comprehensive medical oversight and strategic direction for clinical trials. This involves designing robust clinical development plans, authoring and refining study protocols, and setting the scientific vision for an asset or entire therapeutic portfolio. They serve as the ultimate medical authority for ongoing trials, reviewing and interpreting safety and efficacy data, and making critical decisions that impact study direction. A significant part of the role is acting as the company's key external scientific voice, building relationships with Key Opinion Leaders (KOLs), advising clinical investigators at trial sites, and presenting data at major scientific congresses. Furthermore, they play an indispensable role in regulatory strategy, directly interacting with Health Authorities like the FDA and EMA to guide successful drug development and support marketing applications. Typical responsibilities for these leadership jobs encompass a wide spectrum of strategic and operational activities. These include leading cross-functional teams comprising clinical operations, regulatory affairs, biometrics, and pharmacovigilance to ensure flawless trial execution. They are deeply involved in data analysis, contributing to clinical study reports, scientific publications, and regulatory documents such as Investigator Brochures and Biologics License Application (BLA) modules. Risk management and patient safety are paramount, requiring continuous monitoring of trial data to uphold the highest ethical standards and compliance with Good Clinical Practice (GCP). Candidates for Senior Medical Director, Clinical Development jobs must possess an M.D. or M.D./Ph.D. degree, often complemented by board certification or significant clinical experience in a relevant therapeutic area such as oncology, immunology, or neurology. The role typically requires 7+ years of direct industry experience in clinical research within a pharma or biotech setting, including a proven track record of designing and leading complex global trials. Essential skills extend beyond deep therapeutic expertise to include exceptional leadership and communication abilities, capable of influencing both internal teams and external stakeholders. Strategic thinking, a results-driven mindset, and the agility to thrive in a dynamic, fast-paced environment are critical. For those seeking to leverage their clinical acumen to drive therapeutic breakthroughs and lead high-impact teams, Senior Medical Director, Clinical Development jobs represent the pinnacle of a career in drug development.

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