Medical Director (R&D) Job Listing at Advance Consulting & Staffing in Parsippany, NJ

Staffing/Employment

Category : Pharmaceutical/Biotech
Location/City : NJ - Parsippany

The Medical Director, Clinical R&D, Urology will lead US specific clinical development programs in urology therapeutic areas.
This position will be responsible for:
Directing clinical staff in support of business goals Medical oversight of US urology clinical trials and US portions of global clinical trials in urology Develops and maintains a thorough and up-to-date knowledge base for assigned projects, including marketed and investigational products, through regular review of the scientific journals as well as attendance at relevant scientific congresses Interacts with colleagues in other R&D departments and functional areas as well as consultants, and regulatory authorities as needed to facilitate the clinical development process. Prepares and/or reviews clinical components of IND and NDA applications to FDA or other regulatory authorities, assuring accurate and timely reporting of information
Participates in local and global working teams Provides medical and scientific review of new chemical entities for potential in-licensing. Maintains a comprehensive knowledge of therapeutic specialty to ensure patient safety and provide optimal strategic positioning and new product evaluation
Recruit and maintain talented clinical research and development team Participate in cross functional process oriented activities as required Develop medical efficacy and safety endpoints Write protocol synopsis and full protocols as required Contribute in the regulatory process during the development and at regulatory submission Interact with global marketing
Participate in publication planning in advisory boards as required Liaise with external scientists to plan and evaluate ongoing product development Evaluate in-license projects as requested Provide clinical guidance and training to in-house Investigator meetings as required Work closely with International Project Development Teams to ensure effective global development projects Seek to continuously improve management skills
Requirements:
MD or MD/PHD with 10 + years of pharmaceutical/biotechnology experience primarily focused on global clinical development, but with strong competencies in Medical Affairs, Regulatory Affairs, PV, and NBD functions.
Multi-national company experience preferred.
Experience writing NDA's required.
Demonstrated expertise in pharmaceutical industry R & D activities
Excellent leadership skills in both vision and execution
Successful track record in an international environment. Ability to work effectively and collaboratively across the global organization
Broad drug development experience along with extensive therapeutic category experience
Strong management skills with ability to proactively institute change to accommodate for rapid organizational growth as well as industry changes
Accomplished scientist, recognized by peers as a leader
Experienced drug development operations manager
Superior interpersonal skills focusing on collaboration and influencing capabilities
Expert project and time management ability and process management skills while managing a complex workload
Skilled networking, negotiation & presentation skills
Experience in negotiating with the FDA and a strong academic background
Experience in working with and influencing management Boards
-This position offers full time benefits including med, dent, 401K, generous vacation, tuit reimb, flex time etc
If interested, please apply or send resume to: JOBS@advance-now.com