The Director of Clinical Science, within the Vitreous and Retina Therapeutic Area Strategy department, will be experienced in Drug Development and Medical Science, and possess leadership competencies and the perspective needed to develop strategy around new medicines. This individual will be responsible for strategic clinical oversight for products in specific ocular disease areas. S/he will be responsible for the design, implementation, monitoring, analysis and reporting of studies conducted within one or more programs. The Associate Director or Director will also participate in developing long-range strategic plans for the molecule(s). The position includes extensive involvement with global, regional and local Research & Development colleagues, Translation Research group, Business Development, Marketing and Sales, Pharmacovigilance, Regulatory and Health Authorities, Healthcare providers, Key Opinion Leaders, Clinical Data Sciences/ Analytics, Study Investigators.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
Provide strategic input and leadership for clinical development (all phases), pre-registration, label extension, pre-market, launch and post launch strategies and life cycle management.
Serve as a Clinical Scientist and Medical Monitor to support the safety of subjects during studies.
Work with cross functional colleagues to develop product protocol synopsis and provide scientific input into protocol development.
Work in, and enable a positive team environment and interact with global clinical, scientific, and marketing teams.
Work with independent Data Monitoring Committee and Steering Committee for assigned product as applicable
Work with cross-functional groups including Clinical Operations, Pharmacovigilance, Data Sciences, and Medical Affairs to contribute medical input during the product development lifecycle from Phase 1 to Phase 4 studies.
Collaborate with Translation Research and Non-Clinical groups for early research-stage programs.
Facilitate and merge strong science into commercially viable products utilizing aggressive timelines; integrate scientific rigor, medical need and commercial value into compelling clinical plans culminating in successful registration and marketing.
Contribute to the evaluation and due diligence activities of Business Development opportunities
Contribute to the develop and implement reliable and high-value publication strategies for new and existing products.
Keeps all partners abreast of projects throughout all applicable intervals.
Cultivate and maintain relationships with Key Opinion Leaders to leverage expertise in optimizing successful clinical programs, obtain insights into trial data and strategies as well as create advocacy to support corporate and program objectives.
Organize, lead and present during Scientific Advisory Boards.
Present clinical study results during Marketing, Publications and other Advisory Boards.
Provide Senior Management with medical evaluation of developing data during the conduct of the study.
Serve as a source for interpretation of clinical study results in conjunction with other medical directors.
Perform other duties as necessary as assigned by management
Core competencies, education, and experience.
MD, MD/PhD, MB or equivalent degree; ophthalmology experience preferred.
Minimum 5 years of relevant work experience in the pharmaceutical/biotech industry.
Experience in managing and medical monitoring of clinical trials is required.
Medical device experience is a plus
Firm working knowledge of scientific and clinical methodology, protocol design, project management for clinical studies.
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
Sound scientific and clinical judgment.
Demonstrated success in the ability to influence decision makers and key stakeholders both internally and externally.
Excellent written/oral communication and presentation skills; demonstrated ability to write clear and concise text on highly technical/scientific topics.
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