Requisition ID 5691BR
Title Executive Director - Hemostasis
Job Category Medical
Job Description To provide medical leadership including the assessment and support of product development and extension, and professional services for Biopharmaceutical marketed products.
RELATIONSHIPS:
This position reports to the Vice President, Clinical Development & Medical Affairs, BioPharm and manages the Clinical Development and Medical Affairs, Hemostasis Team. It is accountable for managing multiple internal relationships within NNI and NNAS. External relationships include working with the medical community and customers.
ESSENTIAL FUNCTIONS:
PROTOCOL DEVELOPMENT
•Conduct needs assessment for therapeutics in healthcare, the risks of intervention and the potential market for intervention.
•Review, refine, prioritize and manage the Hemostasis Clinical Trials Program.
•Develop medical affairs capabilities.
•Manage core project teams between NNI and NNAS to integrate clinical /medical core programs.
PRODUCT SUPPORT AND SAFETY
•Evaluate reports of adverse outcomes, apply clinical medical acumen and interpret regulatory guidelines and directives to judge risk and causality.
•Participate in meetings and the Promotional Review Board (PRB).
•Assure the ongoing safety and adequacy of labeling of NNI's marketed products from a medical perspective.
SALES AND MARKETING
•Provide medical input to marketing plans, promotional campaigns and new product launch platforms.
PRODUCT DISCOVERY AND DEVELOPMENT
•Coordinate Medical Department strategic review of in-licensing candidates and external development projects for NNI’s existing in-line product franchises.
MEDICAL AND PATIENT COMMUNITY
•Must have (and continue to build) relationships with key thought leaders in the hemophilia community.
•Develop educational curricula to effectively teach.
•Serve as an expert in hematology.
•Maintain necessary credentials and remains in good standing within the medical community and medical ethics boards.
DEVELOPMENT OF PEOPLE:
•Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
•Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way •Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
•MD and 5 plus years Industry experience. Pharmaceutical development or
research experience, including expertise in clinical trial methodology and medical product support, and medical affairs.
•Hematology experience specializing in bleeding disorders is required.
•Experience in development 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-IIIB and IV clinical trials experience required.
•Some clinical and previous patient care experience required.
•Strategic/Tactical planning experience within a pharmaceutical environment is required.
•Able to assess a clinical outcome and relate it to a drug.
Department CMR - HEMOSTASIS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 30 - 40%
Title Executive Director - Hemostasis
Job Category Medical
Job Description To provide medical leadership including the assessment and support of product development and extension, and professional services for Biopharmaceutical marketed products.
RELATIONSHIPS:
This position reports to the Vice President, Clinical Development & Medical Affairs, BioPharm and manages the Clinical Development and Medical Affairs, Hemostasis Team. It is accountable for managing multiple internal relationships within NNI and NNAS. External relationships include working with the medical community and customers.
ESSENTIAL FUNCTIONS:
PROTOCOL DEVELOPMENT
•Conduct needs assessment for therapeutics in healthcare, the risks of intervention and the potential market for intervention.
•Review, refine, prioritize and manage the Hemostasis Clinical Trials Program.
•Develop medical affairs capabilities.
•Manage core project teams between NNI and NNAS to integrate clinical /medical core programs.
PRODUCT SUPPORT AND SAFETY
•Evaluate reports of adverse outcomes, apply clinical medical acumen and interpret regulatory guidelines and directives to judge risk and causality.
•Participate in meetings and the Promotional Review Board (PRB).
•Assure the ongoing safety and adequacy of labeling of NNI's marketed products from a medical perspective.
SALES AND MARKETING
•Provide medical input to marketing plans, promotional campaigns and new product launch platforms.
PRODUCT DISCOVERY AND DEVELOPMENT
•Coordinate Medical Department strategic review of in-licensing candidates and external development projects for NNI’s existing in-line product franchises.
MEDICAL AND PATIENT COMMUNITY
•Must have (and continue to build) relationships with key thought leaders in the hemophilia community.
•Develop educational curricula to effectively teach.
•Serve as an expert in hematology.
•Maintain necessary credentials and remains in good standing within the medical community and medical ethics boards.
DEVELOPMENT OF PEOPLE:
•Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
•Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way •Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
•MD and 5 plus years Industry experience. Pharmaceutical development or
research experience, including expertise in clinical trial methodology and medical product support, and medical affairs.
•Hematology experience specializing in bleeding disorders is required.
•Experience in development 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-IIIB and IV clinical trials experience required.
•Some clinical and previous patient care experience required.
•Strategic/Tactical planning experience within a pharmaceutical environment is required.
•Able to assess a clinical outcome and relate it to a drug.
Department CMR - HEMOSTASIS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 30 - 40%