Medical Director - Clinical Development & Research

6+ years

Not Disclosed

Plainsboro

10 Nov. 11, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Director, Clinical Research & Development

Location: [Location]
Company: Novo Nordisk

About the Department:

The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is one of the most dynamic and collaborative teams within the organization. CMR is at the heart of advancing patient care, from engaging healthcare providers and developing regulatory strategies with the FDA, to supporting medical education and gathering data for new product development. Our unified purpose is to improve the lives of patients worldwide by evolving alongside their needs, using innovation and evidence-based solutions to enhance their quality of life. At Novo Nordisk, we are committed to changing lives for the better — are you ready to be part of this transformative journey?

The Position:

We are looking for a Medical Director to bring medical and clinical expertise to the design, implementation, and monitoring of clinical studies (Phase 1 to Phase 4) as part of a highly skilled team. This role will also provide key medical and scientific support across various activities in the assigned therapeutic area.

As a Medical Director, you will work closely with internal teams, including Clinical Trial Management, Medical Affairs, and Regulatory Affairs, while fostering relationships with external stakeholders such as expert advisory board members, investigators, and regulatory bodies. You will play a crucial role in ensuring that clinical trials and related activities align with Novo Nordisk’s mission and standards for excellence.

Key Responsibilities:

Evidence Generation Planning:
Provide regional medical and scientific input to the evidence generation planning process, including Product Development Plans and Evidence Generation Plans.
Clinical Study Management:
- Develop and provide input on trial protocols, feasibility, and site selection.
- Ensure timely study initiation and act as a liaison with Regulatory Affairs, project teams, and investigators.
- Support recruitment and retention activities and provide medical support during investigator meetings.
- Assist in the development of study-specific training, including disease-specific and titration training.
- Review and provide input on protocol amendments, medical monitoring plans, and deviations.
Regulatory Liaison:
- Review and contribute to clinical trial reports, statistical reports, investigator brochures, INDs, NDAs, and responses to regulatory questions.
- Provide medical and scientific input to advisory committee hearings and labeling efforts.
- Assist in interpreting regulatory guidelines to assess risk and causality.
Medical and Scientific Support:
- Stay up-to-date with current trends, guidelines, and medical practices in the assigned therapeutic area.
- Represent Novo Nordisk at investigator meetings, professional societies, and scientific conferences.
- Contribute to Health Economics and Outcomes Research (HEOR) studies, Real World Evidence (RWE) studies, and market access dossiers.
- Provide medical input to Marketing/Market Access teams as required.
Project Management Liaison:
- Assist in developing clinical program timelines, budgets, and strategies to meet project goals.

Qualifications:

M.D. required; a PhD is a plus but not required.
A minimum of 6 years of relevant experience, with a preference for academic research or pharmaceutical development experience.
Board certification or relevant experience in the therapeutic areas of diabetes, cardiovascular (CV), or obesity is required.
Proven experience in clinical research, including monitoring clinical studies and knowledge of drug development phases.
Strong leadership, project management, and communication skills, with the ability to manage complex projects and collaborate across functions.
Ability to maintain necessary medical credentials and remain in good standing with medical ethics boards and the medical community.

Physical Requirements:

10-20% overnight travel required.

Why Novo Nordisk?

At Novo Nordisk, we recognize that being the best company in the world is no longer enough — we strive to be the best company for the world. We are committed to fostering a culture that celebrates diversity, inclusion, and a shared vision to improve the lives of patients globally. Together, we are driving change, transforming healthcare, and empowering patients.

Equal Opportunity Employer:

Novo Nordisk is an equal opportunity employer. We consider all qualified applicants for employment without regard to race, ethnicity, religion, gender, sexual orientation, disability, protected veteran status, or any other characteristic protected by law.

How to Apply:

If you are ready to contribute to our mission of changing lives, submit your CV through our online application portal. Should you require assistance or accommodations during the application process, please call 1-855-411-5290. This number is for accommodation requests only and cannot be used for status inquiries.