Ocular Therapeutix, Inc Director, Medical Affairs Strategy and Operations in Bedford, Massachusetts
A unique opportunity to become an integral part of a rapidly emerging and innovative ophthalmic biopharmaceutical company. Ocular Therapeutix is seeking an experienced Medical Affairs Director who thrives in a fast-paced environment and shares our passion for transforming the industry in developing and commercializing first-of-a-kind therapies. The successful candidate will be responsible for defining Medical Affairs Strategy and ensuring the successful execution of the strategy to achieve the corporate and/or product vision. This includes leading the articulation of a Medical Affairs plan for each asset.
The Director will work in close collaboration with the Clinical and Commercial teams to define and drive the execution of brand strategies within the Medical Affairs function. The individual will also work closely with other members of the Medical Affairs team as well as cross-functional colleagues to ensure insight sharing and efficient execution of strategic tactics and programs.
The role will be accountable for the development and execution of multi-year medical strategy for all product areas, appropriately aligned with overall strategy and incorporate R&D functional strategies (clinical, regulatory, health economics & outcomes research, pharmacovigilance, compliance); including strategy for in-line R&D lifecycle management, publications, congress s, customer interaction, and the scientific communication platform for the disease area/brand(s), aligned with product strategy. This includes pre and post-launch planning/strategy. In addition to supporting the development of the in-year medical tactical plan and the management of the budget for tactical initiatives, the Director of Medical Affairs will collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution of brand initiatives. This individual will also participate in development of product strategy, providing medical affairs and R&D inputs for product(s) to relevant product strategy team(s). The Director of Medical Affairs is also responsible for monitoring and communicating progress against medical plan; proposing and launching initiatives as needed to adjust to disease area requirements.
The successful candidate will act as a company representative, interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities when necessary. This will include, but is not limited to, planning, designing and managing national, regional, and local medical Advisory Boards; providing medical review of Investigator Initiated Research (IIT) proposals and other grants through the grant approval process; managing design and execution of clinical studies (phase IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with therapeutic area clinical development and clinical operations; managing completion of regulatory obligations. The Director, Medical Affairs will represent Medical Affairs at internal and external meetings, present data on product/disease areas, serve as a key medical resource for the disease areas and specific products, and maintain a high level of expertise on the disease areas. Additionally, this role will establish appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest. In alignment with medical strategy, establish and/or enhance partnerships with key academic institutions, develop relationships with key thought leaders, and act as a company representative with external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities.
The Director, Medical Affairs will provide leadership for scientific communications, including standard responses and publications; as needed, provide Medical review of promotional and non-promotional materials; assist with preparation, medical review and approval of promotional and meeting materials, and serve as medical representative on standing and project-based cross-functional teams. This individual will develop and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and company policies related to all medical activities and develop, conduct, or participate in therapeutic training programs for internal departments. They will build and supervise a team per the department functional plan.
Strategy Development and Leadership
Lead the development of brand and pipeline medical strategy and plans, including launch plans when applicable
Facilitate processes to develop and gain approval on medical strategy and plans
Collaborate with cross-functional teams to drive brand strategy, ensure alignment across teams, and provide compliant medical input
Define the medical life cycle strategy
Develop scientific conference strategy and support the implementation of scientific conference plans
Drive the development of the scientific communication platform
Develop training plans for Medical Affairs stakeholders, and content where needed, based on scientific communications platform
When appropriate, represent Ocular Therapeutix at external meetings with stakeholders per medical strategy
Assimilate field derived insights to actionable plans addressed within the medical strategy
New Product Development
Participate in development of product strategy; provide strategic medical affairs insight to early-stage, mid-stage, and in-line products through cross-functional partnership
Support business development efforts through the delivery of medical insight
Conduct secondary research and present data on product/disease areas of interest as needed; serve as a key medical resource for the disease areas and specific products and maintain a high level of expertise on relevant and related disease areas
Data Generation and Dissemination
Drive the development of a post-market data generation strategy (including but not limited to Phase 4 and investigator-initiated trial, IIT research initiatives)
Collaborate with clinical and/or contracted Clinical Research Organizations (CROs) to ensure management of these trials as appropriate
Work with Regulatory to design and implement post-approval clinical studies
Medical Affairs Operations
Write and update SOPs for Medical Affairs ensuring compliance with all relevant external guidelines
Facilitate key processes including grant review and IIT review committees
Manage Medical Affairs department budget
Track and communicate progress against plans and goals
Management of critical vendors as needed
May oversee the work of external consultants and manage multiple vendors
Oversee Manager Medical and Scientific Communications, Manager Late Phase Research & Grants, Medical Affairs Operations, Medical Affairs Biostatistician
5+ years’ experience in Medical Affairs or related fields
Advanced degree with health science background (PharmD, MD, PhD, or OD) preferred
Experience in the ophthalmic pharmaceutical space preferred
Knowledge of eye care preferred
Knowledge and understanding of the pharmaceutical commercialization process
Experience with the medical publications process
Management of consultants and vendors
Ability to lead complex processes
Ability to navigate complex discussions
Excellent verbal & written communication skills
Ability to work with and collaborate will all levels and groups
Ability to travel 30%
External Company Name: Ocular Therapeutix, Inc.
External Company URL: http://www.ocutx.com/
Street: 24 Crosby Drive