Requisition ID 13202BR
Title Medical Director
Job Category Medical
Job Description PURPOSE:
Assist the Sr. Medical Director in developing and implementing the medical affairs strategy for a particular brand within Diabetes. Coordinate medical activities linked to the Brand in conjunction with the Sr. Medical Director. Assist the Sr. Medical Director in managing the program for phase 3b/4 clinical trials program, defining strategies to support medical education programs, reviewing medical and scientific content of promotional materials, maintaining KOL relationships and serving as a consultant for Marketing, FMA, MC&G and Sales. Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio within the continuum of diabetes care. Review the representation of medical affairs in promotional review board (PRB) activities.
RELATIONSHIPS:
This position reports directly to the Sr. Medical Director, Medical Affairs – Diabetes and will assist the Sr. Medical Director in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Assist in driving the Brand’s Project House Team. Contribute to the Brand’s PPG and EBT.
ESSENTIAL FUNCTIONS:
COMMUNICATIONS/TRAINING: Assists in the review of educational curricula to effectively teach and assist in the training of sales representative, Drug Information specialists, Field Medical Affairs, and Investigators
In conjunction with the Sr. Medical Director may serve as a representative of Novo Nordisk Inc. Medical department in regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, seminars, and conventions
Maintains required credentials and remains in good standing within the medical community and medical ethics boards
Stays abreast of regulatory requirements and guidelines and current trends and medical practice in the field of endocrinology and diabetes, including reports and intelligence on new technologies or treatment advances
MEDICAL COMMUNICATIONS: Assists in developing brand-specific medical education strategy (CME, medical grants, AMCs/professional societies) incorporate into 5 year plans and assess impact
Assists in the development of brand-specific publications strategy (primary, secondary and HEOR), with input from Medical Operations, and Global Publications.
Assists the Director of Medical Education in overseeing NNI support to external medical educations programs
Provides medical input to manuscripts based on clinical trial results and on general diabetes topics
Reviews all brand-specific promotional materials (finalized medical input for PRB)
Supports Medical Information and Field Medical Affairs units
REGULATORY AND SAFETY ACTIVITIES: Assists in assuring the ongoing safety and adequacy of labeling of the Brand from a medical perspective
Assists in the interpretation of regulatory guidelines and directives to judge risk and causality
Assists the Sr. Medical Director in ensuring quality execution by collaborating closely with CTM and FMA in selection investigators/sites, ensuring screening and accuracy, and guiding interpretation.
Assumes primary accountability as representative in Promotional Review Board (PRB) activities. This role requires full knowledge of diabetes product portfolio and understanding of various Federal and Pharma regulations and guidelines as well as in depth knowledge of diabetes disease state.
Supports the definition and implementation of the Brand’s labeling strategy.
SALES AND MARKETING SUPPORT: Assists the Sr. Medical Director in presenting the Brand’s clinical data at regional and national advisory boards
Assists the Sr. Medical Director in providing medical input to the Brand’s market shaping strategy, marketing plans and promotional campaigns
Participates in advisory boards, speaker training, Medical Marketing meetings, and other marketing activities as needed
Participates in the development of medical product support and development plans for the Brand in concert with Sales and Marketing
Supports ongoing sales and marketing objectives by assisting the Sr. Medical Director in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and P&T committees
Works closely with Medical Information to assure that communication from Novo Nordisk is scientifically accurate and clinically appropriate
STRATEGY AND PROTOCOL DEVELOPMENT: Assist the Sr. Medical Director in developing and executing brand–specific phase 3b/4 trial strategy including prioritization criteria, with input from Marketing and Global, and incorporate into annual and five-year plans, formalizing template and process to streamline protocol design, and developing brand-specific IIS strategy, including prioritization criteria, and support its execution.
Assists Sr. Medical Director in providing NNI medical input on the Brand’s global clinical development plan.
Collaborate closely with HEOR group on brand-related activities (providing input into early economic models/endpoints for phase 1-3, phase 3b/4, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications)
In collaboration with the Sr. Medical Director, build relationships and maintain a strong KOL network
Participate in Medical Marketing discussions regarding local and global clinical trials and assists with the preparation of Local Trial Proposal form as needed
Participates in global publication planning team for the brand, along with NNI Medical Operations.
Provide medical/scientific input into the Brand’s development and marketing strategies in consultation with the Sr. Medical Director
Provides content and ideas for publications run by Medical Operations.
Reviews brand-specific IIS proposals
PHYSICAL REQUIREMENTS:
Must be able to travel and work on weekends 20-30% of the time.
DEVELOPMENT OF PEOPLE:
Not Applicable
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An MD or DO and 5 years’ experience, with clinical and prior direct patient care experience
Research or pharmaceutical industry experience in the field of endocrinology and metabolism 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 (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, IIS, med ed).
Subspecialty training in endocrinology and metabolism preferred
Department CMR - MEDICAL AFFAIRS DIABETES (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%
Title Medical Director
Job Category Medical
Job Description PURPOSE:
Assist the Sr. Medical Director in developing and implementing the medical affairs strategy for a particular brand within Diabetes. Coordinate medical activities linked to the Brand in conjunction with the Sr. Medical Director. Assist the Sr. Medical Director in managing the program for phase 3b/4 clinical trials program, defining strategies to support medical education programs, reviewing medical and scientific content of promotional materials, maintaining KOL relationships and serving as a consultant for Marketing, FMA, MC&G and Sales. Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio within the continuum of diabetes care. Review the representation of medical affairs in promotional review board (PRB) activities.
RELATIONSHIPS:
This position reports directly to the Sr. Medical Director, Medical Affairs – Diabetes and will assist the Sr. Medical Director in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ. External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Assist in driving the Brand’s Project House Team. Contribute to the Brand’s PPG and EBT.
ESSENTIAL FUNCTIONS:
COMMUNICATIONS/TRAINING: Assists in the review of educational curricula to effectively teach and assist in the training of sales representative, Drug Information specialists, Field Medical Affairs, and Investigators
In conjunction with the Sr. Medical Director may serve as a representative of Novo Nordisk Inc. Medical department in regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, seminars, and conventions
Maintains required credentials and remains in good standing within the medical community and medical ethics boards
Stays abreast of regulatory requirements and guidelines and current trends and medical practice in the field of endocrinology and diabetes, including reports and intelligence on new technologies or treatment advances
MEDICAL COMMUNICATIONS: Assists in developing brand-specific medical education strategy (CME, medical grants, AMCs/professional societies) incorporate into 5 year plans and assess impact
Assists in the development of brand-specific publications strategy (primary, secondary and HEOR), with input from Medical Operations, and Global Publications.
Assists the Director of Medical Education in overseeing NNI support to external medical educations programs
Provides medical input to manuscripts based on clinical trial results and on general diabetes topics
Reviews all brand-specific promotional materials (finalized medical input for PRB)
Supports Medical Information and Field Medical Affairs units
REGULATORY AND SAFETY ACTIVITIES: Assists in assuring the ongoing safety and adequacy of labeling of the Brand from a medical perspective
Assists in the interpretation of regulatory guidelines and directives to judge risk and causality
Assists the Sr. Medical Director in ensuring quality execution by collaborating closely with CTM and FMA in selection investigators/sites, ensuring screening and accuracy, and guiding interpretation.
Assumes primary accountability as representative in Promotional Review Board (PRB) activities. This role requires full knowledge of diabetes product portfolio and understanding of various Federal and Pharma regulations and guidelines as well as in depth knowledge of diabetes disease state.
Supports the definition and implementation of the Brand’s labeling strategy.
SALES AND MARKETING SUPPORT: Assists the Sr. Medical Director in presenting the Brand’s clinical data at regional and national advisory boards
Assists the Sr. Medical Director in providing medical input to the Brand’s market shaping strategy, marketing plans and promotional campaigns
Participates in advisory boards, speaker training, Medical Marketing meetings, and other marketing activities as needed
Participates in the development of medical product support and development plans for the Brand in concert with Sales and Marketing
Supports ongoing sales and marketing objectives by assisting the Sr. Medical Director in making presentations as appropriate to external groups such as academic and community medical departments, professional associations, and P&T committees
Works closely with Medical Information to assure that communication from Novo Nordisk is scientifically accurate and clinically appropriate
STRATEGY AND PROTOCOL DEVELOPMENT: Assist the Sr. Medical Director in developing and executing brand–specific phase 3b/4 trial strategy including prioritization criteria, with input from Marketing and Global, and incorporate into annual and five-year plans, formalizing template and process to streamline protocol design, and developing brand-specific IIS strategy, including prioritization criteria, and support its execution.
Assists Sr. Medical Director in providing NNI medical input on the Brand’s global clinical development plan.
Collaborate closely with HEOR group on brand-related activities (providing input into early economic models/endpoints for phase 1-3, phase 3b/4, guiding trial design, assimilating HEOR input, and supporting data review for secondary publications)
In collaboration with the Sr. Medical Director, build relationships and maintain a strong KOL network
Participate in Medical Marketing discussions regarding local and global clinical trials and assists with the preparation of Local Trial Proposal form as needed
Participates in global publication planning team for the brand, along with NNI Medical Operations.
Provide medical/scientific input into the Brand’s development and marketing strategies in consultation with the Sr. Medical Director
Provides content and ideas for publications run by Medical Operations.
Reviews brand-specific IIS proposals
PHYSICAL REQUIREMENTS:
Must be able to travel and work on weekends 20-30% of the time.
DEVELOPMENT OF PEOPLE:
Not Applicable
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An MD or DO and 5 years’ experience, with clinical and prior direct patient care experience
Research or pharmaceutical industry experience in the field of endocrinology and metabolism 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 (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, IIS, med ed).
Subspecialty training in endocrinology and metabolism preferred
Department CMR - MEDICAL AFFAIRS DIABETES (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%