Senior Medical Director
2 weeks ago
Senior Medical Director - Nephrology
Requisition
JR000015353 Senior Medical Director - Nephrology (Open)
Location
Bridgewater, NJ
Additional Locations
Job Description Summary
The Senior Medical Director Nephrology will serve as a critical member of the Global Medical Affairs team. They are responsible for leading and driving the overall medical strategy taking into consideration the medical, scientific, regulatory and commercial issues and opportunities for assigned portfolio products. The Medical Director Nephrology leads a multi-disciplinary, matrix team through highly complex decisions. The individual has ultimate responsibility for assessing and integrating input from various disciplines to create and execute a Medical Strategic and Tactical Plan.
The Senior Medical Director will provide expert medical/scientific advice and guidance to support the needs of non-medical internal partners within the Nephrology indications (e.g., clinical operations, marketing, Field Medical, Compliance, etc.) and plays a critical role in the Promotional Review Committee. They support the Nephrology strategy and planning through collaboration with external parties and internal leaders. They continually seek to increase market awareness and expertise by fostering relationships with outside organizations/experts to support research programs, clinical development programs and licensed product maintenance and optimization. This includes leading Medical Advisory Board and Expert Panel meetings, Medical Education Grants, External Collaborative Research and Medical Publications.
Job Description
Essential Functions
- Possesses deep specialty/scientific knowledge and in-depth knowledge of medical affairs and clinical development within the Nephrology specialty.
- Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific objectives and business objectives of the Nephrology specialty.
- Represents the company with outside groups. Works to understand the evolving healthcare environment (provider/expert) and payer landscapes and translates that working knowledge into a plan.
- As the Nephrology expert, the incumbent may author/review/approve content used for publications and promotions.
- Contributes to grant strategy and participates in internal and external events/forums to advance business.
- Leads development and implementation of the annual Nephrology Medical Strategic & Tactical Plan. Develops a product strategy for Medical Advisory Boards and Expert Panel meetings, Medical Grants, and Medical Publications.
- Determines the scientific objectives and ensures creation of content for Field Medical teams, ensuring staff are appropriately trained and informed of brand goals and strategy for the Nephrology indications.
- Collaborates with Scientific Communications, Field Medical, Clinical Development and Operations, ensuring the Company is collecting the appropriate information/data, monitoring, analyzing and translating this data into an actionable plan with measurable objectives.
- Provides strategic direction and scientific support for developing standard response letters and responses to HCP inquiries working with Medical Information Services. Develops IIR/ECR research objectives and serves as a member of the IIR/ECR review team evaluating submitted proposals.
- Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and Annual NDA and IND Report submissions.
- Participates in the Promotional Review Committee, Medical Review Committee, Grant Review Committee and Scientific Review Committee.
- Develops and executes the Nephrology phase IV plan and is directly responsible for protocol development, analysis plan, study execution, data read out and interpretation.
Education / Experience / Skills:
- Doctoral degree from an accredited institution (e.g. PhD, MD, and DO) or Doctoral degree in Pharmacy required.
- Boarded in Nephrology preferred.
- Extensive industry experience in US Medical Affairs.
- Minimum 10 years' healthcare experience.
- Minimum 7 years pharmaceutical industry experience (5 years as Medical Director).
- Clear record of successfully planning and executing Medical Affairs and/or Clinical Development strategy, clinical trials, and a demonstrated ability to function at a program.
- Experience in an Academic Medical environment with an established record of clinical investigation preferred.
- Experience in conducting phase IV clinical research.
- Ability to work effectively in a multidisciplinary team.
- Exhibits flexibility in working collaboratively across internal and external stakeholders
- Demonstrated business acumen with ability to balance need for maintaining high scientific standards with business relevance and impact.
- Excellent communication skills.
- Ability to quickly and comprehensively learn about new subject areas and environments and effectively communicate that information.
- Demonstrated ability to establish strong customer relationships
- Focus on patient and external customers
- Must be committed to full compliance with company SOPs, all applicable laws and regulations including ICH-GCP, FDA Guidance Documents for the Industry, PhRMA and ADVAMED guidelines.
- This position reports to the Head of Global Medical Affairs. The Senior Medical Director will interact with internal colleagues in the Global Medical Department, Marketing, Sales, Research and Development, strategy/portfolio management, Regulatory Affairs, and Pharmacovigilance. External collaboration includes trade associations, professional societies, payers, clinicians, and policy thought leaders, and various government personnel and agencies. Collaboration across a matrix organization is critical.
- Hybrid work schedule at our Bridgewater, NJ office preferred. Open to considering remote based with committed travel schedule to our NJ location.
- National travel 10-15% of time.
The expected base pay range for this position is $215K - $280K. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.
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