Sr. Dir, Medical Affairs

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4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY

The Senior Director, Medical Affairs, Ophthalmology will contribute to the development and execution of the medical affairs strategy in Ophthalmology. This role will collaborate with clinical development, clinical development operations, scientific communications, external engagement, biometrics, data management, regulatory affairs, drug safety, commercial, and alliance partners.

The Senior Director will develop and/or substantially contribute to the implementation of the portfolio strategy and life cycle management planning across indications. The successful candidate will be responsible for cross-functional communication and collaboration across the organization to ensure the execution of global medical affairs strategy across all geographic regions ensuring a cohesive approach for the franchise. This role will lead medical affairs activities ensuring partnership within the team (medical strategy, scientific communications and publications) and across all key Medical Affairs functions (Medical Excellence, HEOR, Field Medical, Medical Information) to ensure alignment and one 4DMT approach. This role will also be the key medical affairs lead for scientific and clinical training initiatives.

Reporting to the VP, Medical Affairs, this individual contributor role will serve as a subject matter expert to internal and external stakeholders. Depending on location, this role may be fully remote or hybrid.

*Experience in retinal disease is required as well as strong Phase III study support and launch preparedness.

MAJOR DUTIES & RESPONSIBILITIES:

• Assist in development of the medical strategy for entry into new indications and across indications ensuring this fits within the overall company strategy and maintaining cross functional alignment.
• Deliver on critical identified milestones.
• Provide input for cross functional partners including clinical development and commercial to ensure that there is a strong medical voice represented.
• Demonstrate strategic thinking to translate medical/clinical insights of treatment paradigms into growth opportunities, while driving competitive advantage.
• Act as scientific reviewer, contribute to company sponsored medical affairs research programs and external research, and lead the creation of a robust scientific education plan for healthcare professionals and other stakeholders as well as internal for global medical training, field medical leadership across all regions and HEOR.
• Build external relationship network for existing and new indications to help drive trial enrollment, launch prep, and gain advice.
• Provide direction into publication planning and review, medical backgrounders, FAQ and standard responses, internal training approach, and data dissemination.
• Develop full thought leader engagement strategic approach and ensuing plan and provide insight to the cross functional medical engagement plans.
• Deliver high quality educational presentations internally and externally, as required.
• Ensure a comprehensive and synergistic approach by collaborating across Medical Affairs, Regions, and other functions incl