Executive Medical Director, Clinical Development - Ophthalmology

Job Description

Reporting to the Head of Therapeutics Development Unit,the Executive Medical Director, Clinical Development - Ophthalmology will lead Biogen’s Clinical Development efforts in Ophthalmology. We have an industry-leading portfolio focused on retinal diseases – both inherited and acquired, targeting major mechanisms underlying retinal degeneration. Success in this role will require world-class expertise and vision in clinical development, from innovative trial design to the discovery of novel endpoints and biomarkers, and accelerated execution through to pivotal studies and filing. He/she will be accountable company-wide for the design and execution of our clinical development pipeline in ophthalmology, specifically retinal disorders and degenerative diseases. Moreover, he/she will play a key leadership role determining strategy, collaborating cross-functionally across Biogen and with external medical experts, presenting to senior leadership, and will be responsible for talent development

• Provides medical leadership and clinical development expertise and oversight for Biogen’s portfolio of assets in Ophthalmology from R2D transition through label-enabling lifecycle management development
• Works closely with the ophthalmology medical directors, ophthalmology research and preclinical teams, to create a seamless, innovative and industry-leading pipeline from idea through marketing and design disease area strategy
• Manages and develops a team of medical directors and clinical scientists responsible for Clinical Development Programs in Ophthalmology, including gene therapies for inherited and acquired retinal disorders
• Presents programs and strategy at governance committees including the R&D Leadership Team, the R&D Governance Committee, Executive Committees, and the Board of Directors
• In collaboration with PDC lead and team, EEPC and R&D cross functional representatives, builds current state assessment, future state vision, and prioritized disease area roadmaps for creation of a winning and durable pipeline for ophthalmologic disorders
• Represents Ophthalmology clinical development for external collaborations & initiatives and clinical development in Biogen R&D and cross-functional initiatives
• Represents Biogen as clinical development at regulatory agencies (FDA, CHMP, PMDA, and others) for both individual programs and portfolio discussions
• Represents the Development Unity (DU) Head in all circumstances as required and member of the DU leadership team to drive DU strategy and execution

Qualifications

The ideal candidate will have the following mix of professional and personal characteristics:

• Post Graduate degree, MD orPhD preferred. Neurologist or Ophthalmologist backgrounds area plus.
• At least twelve (12)years of overall relevant experience within pharmaceutical/biotech industry and a background of clinical research is required.Experience or knowledge of orphan or genetic rare disease drug development a plus.
• A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s)
• Extensive knowledge of basic and clinical science, broad understanding of the ophthalmicdisease areas, established links with the medical community around the world
• Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence; demonstrated strategic and critical thinking
• The ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills
• Able to facilitate discussions among groups with diverse technical expertise and drive decisions on complex issues

Additional Information

The Executive Medical Director, Clinical Development - Ophthalmologywill provide leadership and direction for the pipeline of clinical development programs in Inherited Retinal Diseases. The successful candidate will be responsible for developing and implementing the overall clinical strategy for the company.