Senior Medical Director - Ophthalmology

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

Essential Functions

• 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.

Minimum Requirements

Education / Experience / Skills:

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

• Boarded in Ophthalmology 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.

Organizational Relationship/Scope:

• 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.

Working Conditions:

• 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.