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
Essential Qualifications
- 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
Preferred Qualifications
- Experience for medical responsibilities on a cross-functional team preferred
- Basic statistical knowledge preferred
Company Description: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.