The Senior Director, Clinical Development Sciences will provide medical input to Global Program Teams (GPTs), serve as medical expert for the study team and medical monitor for phase 1-2 clinical trials.
The Senior Director is typically responsible for 1 or more medium sized clinical development programs under the supervision of either an Executive Director or a VP Clinical Development TA Head. In addition, she/he may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target). This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.
Job Duties & Responsibilities
Medical input to the Global Development Team / Subteam
Medical Expert for clinical study team
Protocol development from concept to final protocol
Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
Scientific interpretation of data from clinical studies
May supervise other medical monitors on individual studies
Strategic guidance to phase I/II/III development programs and oversight of global clinical trials/trial team (s) on assigned programs
Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
Presentation at academic congresses, investigator meetings and advisory meetings
Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
Providing medical/scientific input to evaluate potential business opportunities
MD/PhD with adequate experience; Board Certification preferred
5-10 years of clinical experience preferably within industry (minimum of 3 years of industry experience may be acceptable for outstanding candidates)
Translational clinical trials
Experience as a medical monitor for clinical trials required
Regulatory experience preferred
Publication in peer reviewed journals
Excellent written / oral communication skills
Attention to detail and ability to think strategically
Willingness to take on new responsibilities
Interest and ability to learn about new therapeutic areas
Interest in career progression and ability to take on a more senior roles in 1-3 years
Experience for medical responsibilities on a cross-functional team preferred
Basic statistical knowledge preferred
Our Client is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies.
Since its founding in 1992, they have given hope to people who had none and shined a light on those who felt isolated and alone. But we know that fighting rare diseases takes so much more than hope. It requires persistence, dedication, and a relentless pursuit of the highest levels of medical innovation. Their goal is to deliver medical breakthroughs where none currently exist. They are driven because we know people's lives are at stake.
Our Client has 2,500 passionate and dedicated employees serving patients in 50 countries around the world.