Sr. Medical Director, Clinical Development, Therapeutics - Newark, CA | Biospace
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Sr. Medical Director, Clinical Development, Therapeutics

Revance Therapeutics, Inc.

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Location:
Newark, CA
Posted Date:
9/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Development, Medical Director,

Job Description


Reporting to the Vice President, Clinical Development, the incumbent will be an integral member of the Revance drug development organization and will contribute significantly as the Company advances its lead programs through the clinic. Revance is at an exciting stage with leadership committed to bringing to market a focused portfolio of products that achieve multiple strategic objectives. This individual will join the Company in a role surrounded by opportunity, and will be in a position of high impact as the Company advances its mission of becoming a global leader in both the underserved therapeutic specialties such as, neurology, urology, dermatology and ophthalmology, as well as aesthetic medicine. The successful applicant will be a member of senior leadership teams, and also perform as a hands-on leader who is both collaborative, a self-starter, and who has the ability to work in a matrixed environment.

The incumbent will contribute significantly to program strategies, decisions and program transition recommendations. This individual will provide direction for the Company’s therapeutic programs and will oversee the design, execution and completion of plans for clinical studies and regulatory filings. He/she will also assume major responsibility for planning and execution of clinical trials for earlier stage programs, organize and lead protocol steering committees, and will perform as a critical member of the leadership team as the Company identifies and drives select programs through clinical development. Additionally, he/she will represent the Company in scientific organizations, industry associations, standards organizations, and regulatory group meetings regarding clinical and regulatory expertise. The individual hired for this role will, therefore, have significant influence on shaping the future of the Company.

The successful finalist for this role will have a Medical Degree (with US or UK/EU Board Certification highly desirable) and must consider the best interests of patients and products as their key objective. They will have a reputation for possessing: (a) personal integrity and a deep seated appreciation for science and medicine (b) a sound reputation within the scientific community and with key opinion leaders in the field of Neurology or related specialty, (c) experience within global biological clinical research and development including in-depth experience in dealing with FDA and international regulatory agencies, (d) experience with  trials involving neurotoxins, (e) previous success with direct responsibility over complex clinical research/development programs as evidenced by successful product development, and (f) a minimum of 5 years’ experience in design, execution, and evaluation of clinical trials and new product submission documents, either in the specialty pharmaceutical or biopharmaceutical industry.

Essential Functions:

•   Establish and approve scientific methods underlying the design and implementation of clinical protocols.
•   Organize and lead protocol steering committees.
•   Represent clinical research through membership on trial teams.
•   Accountable for all study protocols in collaboration with the Biometrics, Clinical Operations, and Medical Affairs groups.
•   Recruit, guide, and motivate clinical investigators.
•   Act as Medical Monitor for Revance sponsored clinical trials and provide adverse event safety monitoring and reporting.
•   Author relevant sections of Clinical Study Reports, BLA/NDA reports, investigator brochures, and other clinical/regulatory/safety documents.
•   Regularly report to the executive management team. If necessary, make recommendations for those studies which need to be re-evaluated, including the decision to halt/terminate a study.
•   Ensure study compliance by understanding and applying all relevant SOPs and GCPs.
•   Present technical information to internal teams; represent Revance externally through publications, presentations at scientific meetings and congresses.
•   Participate in long range strategic product planning for current and future products.

Requirements


Preferred Experience:

•   Minimum 7 years’ experience in the design, execution and evaluation of clinical trials, with an emphasis on phases 2-3.
•   Experience with trials involving neurotoxins
•   Responsibility for physician sponsored or commercially sponsored clinical trials is a plus.
•   In-depth understanding of pharmaceutical regulatory requirements and their impact on development of clinical trials and BLA/NDA.
•   An active network in key CNS therapeutic areas. This will include KOLs, key research centers, patient advocacy groups and a variety of patient care organizations.
•   Able to write clearly and succinctly in a variety of communication settings.
•   Open, transparent and succinct communication skills.
•   Experience working with corporate and academic partners is a plus.

Preferred Education:

•   MD. or M.D./Ph.D is required. U.S. Board certification and/or clinical training in neurology preferred.