|
WHAT
IN
Executive Director Clinical Pharmacology Research
Job
Novo Nordisk
US
-
Princeton,
New Jersey
Job Code - 2559BR
Position - FULL TIME
Job First Active on: Wednesday, October 28, 2009
APPLY TO THIS JOB (You will be applying directly to Novo Nordisk for this position!)
JOB DESCRIPTION: Executive Director Clinical Pharmacology Research
Scientific leader serving as mentor, overseeing training of Novo Nordisk CPR clinicians involved in early development projects including Princeton IMOs and clinical pharmacologists. Interface with NNA/S clinical development to facilitate and advance global development by sharing best practices, attaining consistency across regions and across projects, and optimizing resource utilization. Interface with discovery, marketing, and regulatory counterparts to develop the overall global development strategy for the Novo Nordisk diabetes portfolio. Responsible for developing clinical and scientific expertise of Diabetes Clinicians and Clinical Pharmacologists.
RELATIONSHIPS:
Reports to the Associate Vice President of Clinical Research, Medical Affairs and Endocrinology. With a dotted line to VP, Developments Project Management (in Denmark).
ESSENTIAL FUNCTIONS:
•Challenge the scientific, regulatory, and marketing assumptions and objectives of developmental plans and clinical trials through direct reports and as a member of the CDP challenge board and PRC
•Participate in GPTs and Medical and Science sub teams as an ad hoc member in order to move projects forward through the regulatory process with high scientific and ethical standards
•Coordinate Novo Nordisk medical input into global regulatory agencies for early development projects
•Oversee the development, implementation, and medical oversight of the NACDC clinical studies from the CPR section
•Build on the Novo Nordisk medical, science, and regulatory expertise for the CPR section by attending relevant scientific meetings, conferences, and courses
•Member of discovery task forces for early projects
•Oversee Novo Nordisk due diligence as assigned
•Chair Novo Nordisk medical protocol review (MPR)
•Chair Novo Nordisk monthly drug development forum meeting (DDF)
•Co-chair annual Novo Nordisk development advisory board meeting
•Serve as member of Novo Nordisk CMR management team
•Foster development of relationships with US and global KOLs
•Help bring Novo Nordisk closer to it’s goal of being a “Center of Excellence” in global clinical development
•Identify individual to assume role as Senior Director, Clinical Pharmacology and Research and mentor that individual to facilitate assumption of these duties.
Facilitating Global Cooperation
•Maintain quarterly meetings to discuss global development strategy, resources, and operational issues; VC/TC as appropriate and as needed
•Monthly Novo Nordisk project updates from Novo Nordisk clinicians, including IMOs and clinical pharmacologists to RIRE and then to the line.
•Annual meeting of NNAS/NNI clinical development groups to discuss projects, resources, sharing of best practices, and other selected topics
•Establishment of the global experimental medicine group
•Global virtual participation in Novo Nordisk monthly drug development forum meetings
•One GPT meeting per year in Princeton for each development project
•Novo Nordisk clinicians to attend GPT and/or Medical & Science team meetings for their assigned projects in Copenhagen at least twice per year
•Access to cross-project GPT and Medical & Science team minutes through a restricted website
DEVELOPMENT OF PEOPLE:
•Identifies competencies and training needs of Clinicians and Clinical Pharmacologists and provides their managers input for development plans, goals, and ratings.
•Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management. Ensures training of SOPs for self and Clinicians.
•Ensure training of Clinicians in accordance with their IDP forms include completed Learning and Aspiration plans to enable the achievement of goals and capability to assume increased levels of responsibility.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•MD 7 plus years Industry experience. Pharmaceutical development or
research experience, including expertise in clinical trial methodology and medical product support, early product development and/or medical affairs.
•Diabetes expertise required.
•Experience in research and regulatory areas required.
•Previous supervisory experience required.
•Administrative responsibilities in an institutionalized setting required.
•Must maintain necessary credentials and remain in good standing within the medical community and medical ethics boards.
•Previous Phase I, IIa, IIb, IIIa, IIIb and IV clinical trials experience required.
•3+ years Clinical and previous patient care experience required.
•Strategic/Tactical planning experience within a pharmaceutical environment is required.
•Demonstrated ability to assess a clinical outcome and relate it to a drug.
REQUIREMENTS - QUALIFICATIONS: Executive Director Clinical Pharmacology Research
See Information Above
Novo Nordisk
Back To Results
Apply to this job!
View Company Jobs
Free Career Test
Your Resume on 75 Job Sites
|
