Vice President, Clinical Development in Parsippany, NJ

$250K - $500K(Ladders Estimates)

Ferring Pharmaceuticals, Inc.   •  

Parsippany, NJ 07054

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 52 days ago

Job Description:

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology) and orthopaedics. Ferring's US operations employ approximately 800 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:

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Responsibilities:


  • Provide leadership and oversight of US clinical development strategy to support the development of the US and overall company clinical portfolio
  • Responsible for guiding the clinical development medical team on the preparation of US (or global) clinical development plans, providing medical input to Investigator's Brochures, study protocols, study reports, regulatory briefing packages and the clinical part of the NDA/BLA dossier
  • Coordinate medical team activities and resources in accordance with budget and agreed time scales to deliver Phase I - Phase IV clinical trials
  • Provide medical expertise to research, non-clinical and translational teams and support in all development phases
  • Liaise with US Development functions (Product Development, Development Operations, Project Management, Regulatory Affairs and Medical Affairs) to ensure input from these functions into clinical development plans
  • Participate in FDA meetings and interactions with other organization to support clinical development projects to be conducted in the US
  • Ensure the development and maintenance of scientific relationships and cooperation with academic external bodies and partners
  • Responsible for administrative aspects, for preparation of individual development plans and for mentoring of the medical team
  • Ensure the team members have the appropriate scientific skills and medical experience and are deployed effectively to meet the development priorities
  • Member of the US Development Leadership Team (DLT) and contribute to strategic and execution of initiatives championed by this group

Requirements:


  • MD degree with a minimum of 10 years of hands-on experience in clinical drug development in either a pharmaceutical or contract research organization
  • High level of knowledge of one or more Ferring core therapeutic areas with a documented track record of conducting trials or publications in one or more of these areas
  • Experience in the design, implementation, and management of clinical trials in all phases of drug development
  • Experience in negotiating with the FDA, with significant number of documented experiences in INDs and NDAs
  • Experience in effectively working within a global organization and at least 5 years in leadership positions
  • Skilled networking, negotiation, communication and presentation abilities
  • Strong team management skills


Valid Through: 2019-10-17