Requisition ID 16549BR
Title Director - Hemostasis
Job Category Medical
Job Description PURPOSE:
Within Clinical Development & Medical Affairs, Biopharmaceuticals, this Director functions as a
clinical/medical advisor for NNI and key external customers to further scientific exchange. Incumbent provides product and field scientific support to Clinical, Medical and Marketing by using academic credentials and scientific expertise to communicate with health care providers and organizations. The Director will also provide leadership and direction for the conduct and reporting of ongoing local Phase I-IV clinical trials. The Director will provide support to Medical Information, Marketing and Regulatory Departments as needed and will be responsible for overseeing the publication of data and review articles in the hemostasis therapeutic area. The Director will also play a major role in the establishment and function of expert advisory panels in the areas of hemostasis and hemophilia. In addition, the Director will work with and influence medical and scientific aspects of global clinical development projects.
RELATIONSHIPS:
Position reports to the Executive Director, Hemophilia. The Director will work closely with Headquarters, the Clinical Trial Management organization, Medical Writing department, The Regulatory Affairs department and Medical Affairs and Marketing organizations Additional key internal relationships are with the regional medical liaisons and directors, research clinicians and clinical project managers, marketing, MCT&G, and Sales personnel. External relationships include key opinion leaders (KOL’s), academic institutions, managed care organizations, physicians, nurse practitioners, and pharmacists.
ESSENTIAL FUNCTIONS:
- Provide monthly (or more frequent, when required) report on all activities to Executive Director
- Identify, contact, develop and maintain relations with health care providers to establish and/or support the use of NNI products; when necessary, assist in resolving issues pertaining to that use.
- Responsible for establishing and coordinating the scientific activities of consultant and advisory boards.
- Maintain a thorough working knowledge of NNI, its products, current scientific research and publications associated with same. Provide medical review for hemophilia related promotional materials.
- Provides leadership for scientific support activities and supports CTO personnel as needed.
- Provides support to Medical Affairs, conduct needs assessment for therapeutics in healthcare, the risks of intervention and the potential market for intervention.
- Scientific support for marketed products and development projects focusing on NovoSeven® in the hemophilia/congenital bleeding disorder area.
- Support the drug information unit, by providing timely review of materials developed for communication with customers, as well as responding to inquiries where specific professional expertise in hemostasis/hemophilia clinical science is required.
- Works with the Executive Director, Hemostasis, the Director, Marketing and the Project Manager(s) to identify scientific needs and research opportunities and implements tactics to support scientific and business needs in the U.S.
-Assist in the development of timelines, and budgets, relevant to the management of ongoing local trials and registries.
- Ensure timely publication of clinical trial results.
- Helps to support and analyze clinical trial and registry data relating to Phase I-IV studies.
- Identify academic centers and investigators to initiate and/or participate in clinical trials and identify key areas of future research.
- Obtain expert medical community input as required to design high quality studies.
- Provide regional medical input on the global clinical development plans related to hemophilia.
- Serve as an advisor to clinical research teams for projects in early stage development.
- Write, review, and/or approve and ensure quality Phase I-IV clinical trial protocols.
- Assist with training of field personnel on product knowledge and use of technical information in selling situations.
- Design, develop, and deliver scientific presentations to individuals and groups of strategic importance to NNI.
PHYSICAL REQUIREMENTS:
Approximately 30% overnight travel.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An M.D. degree with completed residency program required, preferably in hematology, critical care or related field.
Clinical trial experience desirable.
Minimum of 5 years’ experience in a pharmaceutical company, preferred hemostasis, hemophilia, bleeding
and clotting disorders experience strongly preferred
Strong strategic mindset, understanding of market needs, resource allocation, etc.
Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools
Department CMR - HEMOSTASIS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%
Title Director - Hemostasis
Job Category Medical
Job Description PURPOSE:
Within Clinical Development & Medical Affairs, Biopharmaceuticals, this Director functions as a
clinical/medical advisor for NNI and key external customers to further scientific exchange. Incumbent provides product and field scientific support to Clinical, Medical and Marketing by using academic credentials and scientific expertise to communicate with health care providers and organizations. The Director will also provide leadership and direction for the conduct and reporting of ongoing local Phase I-IV clinical trials. The Director will provide support to Medical Information, Marketing and Regulatory Departments as needed and will be responsible for overseeing the publication of data and review articles in the hemostasis therapeutic area. The Director will also play a major role in the establishment and function of expert advisory panels in the areas of hemostasis and hemophilia. In addition, the Director will work with and influence medical and scientific aspects of global clinical development projects.
RELATIONSHIPS:
Position reports to the Executive Director, Hemophilia. The Director will work closely with Headquarters, the Clinical Trial Management organization, Medical Writing department, The Regulatory Affairs department and Medical Affairs and Marketing organizations Additional key internal relationships are with the regional medical liaisons and directors, research clinicians and clinical project managers, marketing, MCT&G, and Sales personnel. External relationships include key opinion leaders (KOL’s), academic institutions, managed care organizations, physicians, nurse practitioners, and pharmacists.
ESSENTIAL FUNCTIONS:
- Provide monthly (or more frequent, when required) report on all activities to Executive Director
- Identify, contact, develop and maintain relations with health care providers to establish and/or support the use of NNI products; when necessary, assist in resolving issues pertaining to that use.
- Responsible for establishing and coordinating the scientific activities of consultant and advisory boards.
- Maintain a thorough working knowledge of NNI, its products, current scientific research and publications associated with same. Provide medical review for hemophilia related promotional materials.
- Provides leadership for scientific support activities and supports CTO personnel as needed.
- Provides support to Medical Affairs, conduct needs assessment for therapeutics in healthcare, the risks of intervention and the potential market for intervention.
- Scientific support for marketed products and development projects focusing on NovoSeven® in the hemophilia/congenital bleeding disorder area.
- Support the drug information unit, by providing timely review of materials developed for communication with customers, as well as responding to inquiries where specific professional expertise in hemostasis/hemophilia clinical science is required.
- Works with the Executive Director, Hemostasis, the Director, Marketing and the Project Manager(s) to identify scientific needs and research opportunities and implements tactics to support scientific and business needs in the U.S.
-Assist in the development of timelines, and budgets, relevant to the management of ongoing local trials and registries.
- Ensure timely publication of clinical trial results.
- Helps to support and analyze clinical trial and registry data relating to Phase I-IV studies.
- Identify academic centers and investigators to initiate and/or participate in clinical trials and identify key areas of future research.
- Obtain expert medical community input as required to design high quality studies.
- Provide regional medical input on the global clinical development plans related to hemophilia.
- Serve as an advisor to clinical research teams for projects in early stage development.
- Write, review, and/or approve and ensure quality Phase I-IV clinical trial protocols.
- Assist with training of field personnel on product knowledge and use of technical information in selling situations.
- Design, develop, and deliver scientific presentations to individuals and groups of strategic importance to NNI.
PHYSICAL REQUIREMENTS:
Approximately 30% overnight travel.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An M.D. degree with completed residency program required, preferably in hematology, critical care or related field.
Clinical trial experience desirable.
Minimum of 5 years’ experience in a pharmaceutical company, preferred hemostasis, hemophilia, bleeding
and clotting disorders experience strongly preferred
Strong strategic mindset, understanding of market needs, resource allocation, etc.
Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools
Department CMR - HEMOSTASIS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%