Senior Medical Director - Ophthalmology

Mallinckrodt Pharmaceuticals•Bridgewater, NJ

12d•Hybrid

About The Position

The Senior Medical Director Ophthalmology 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 Ophthalmology 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 Ophthalmology indications (e.g., clinical operations, marketing, Field Medical, Compliance, etc.) and plays a critical role in the Promotional Review Committee. They support the Ophthalmology 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.

Requirements

Doctoral degree from an accredited institution (e.g. PhD, MD, and DO) or Doctoral degree in Pharmacy required.
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.
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.

Nice To Haves

Boarded in Ophthalmology preferred.
Experience in an Academic Medical environment with an established record of clinical investigation preferred.
Experience in conducting phase IV clinical research.

Responsibilities

Possesses deep specialty/scientific knowledge and in-depth knowledge of medical affairs and clinical development within the Ophthalmology 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 Ophthalmology 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 Ophthalmology 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 Ophthalmology 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 Ophthalmology 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 Ophthalmology phase IV plan and is directly responsible for protocol development, analysis plan, study execution, data read out and interpretation.