Posted to MedZilla on 1/13/2018

Novo Nordisk

US-NJ, Director- Clinical Development & Research (Multiple positions) Job 444488400A1-MZ


Requisition ID 51802BR
Title Director- Clinical Development & Research (Multiple positions)
Job Category Clinical Development
Job Description Purpose
Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.

Reports to the Executive Director- Clinical Development & Research- Diabetes & Obesity. Internal relationships include working with Headquarters, North America (NA) Clinical Medical Regulatory (CMR) including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other Novo Nordisk Inc. (NNI) skill areas. External relationships include expert advisory board members, investigators, regulators, academic and pharma associations and other consultants.

Essential Functions
Clinical Study Management: Provide regional medical & scientific input into trial planning and project strategic documents, including NNI Evidence Generation Plans and Product Development Plans. Provide regional medical & scientific input to trial outlines and trial protocols. Manage all required local protocol amendments/deviations. Assist in the recruitment of investigators for clinical studies and provide medical support to investigator meetings. Provide protocol training, disease specific training and titration training. Assure timely initiation of studies; act as liaison with Regulatory, project teams, and investigators. Support recruitment & retention activities. Provide medical monitoring and follow-up and support Risk Based Monitoring activities. Obtain expert medical community input. Regulatory Liaison: Assist in providing medical representation at Regulatory meetings. Write and/or review clinical sections of clinical trial reports, statistical reports, investigator’s brochures, investigational new drug application (INDs), new drug application (NDA) and responses to Regulatory questions. Provide medical and scientific input to advisory committee hearings when requested. Provide medical and scientific input to labelling. Assist in the interpretation of regulatory guidelines and directives to judge risk and causality. Medical and Scientific Support for Health Economics & Outcomes Research (HEOR) & Market Access Activities: Provide medical and scientific input to HEOR studies, real-world evidence (RWE) studies and value dossiers for market access. Provide medical and scientific input to Marketing/Market Access departments as needed. Project Management Liaison: Assist in developing clinical program time lines, budgets, and strategies. Through the project development team, assure timely initiation and completion of studies of qualified patients. Other essentials: Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards. Stay abreast of regulatory requirements and guidelines and current trends and medical practice in the field of endocrinology, diabetes and obesity, including reports and intelligence on key and critical new technologies or treatment advances. Represent Novo Nordisk (NN) in regulatory interactions, investigators’ and expert advisory board meetings, external professional societies, pharma associations, seminars, and conventions. Collaborates with other skill areas in Clinical Development & Outcomes Research (CDOR), CMR and NNI in general to ensure seamless collaboration across skill areas.

· M.D. required with a PhD additionally desired.
· A minimum of 6 years relevant experience required; pharmaceutical experience preferred.
· Diabetes, Obesity and/or NASH experience desired.
· Prior clinical research or related experience (e.g. monitoring of clinical studies, knowledge of drug development phases, statistical research methodology experience).
· Leadership skills; project management skills; effective communication and presentation skills.
· Strong collaborative mindset required.
· Must maintain necessary credentials and remain in good standing within the medical community and medical ethics boards.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Position Location US - Plainsboro, NJ
City Plainsboro
State/Provinces US - NJ
Job/Position Country US

At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness

With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!

Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.

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