Director, 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 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 Director is will contribute to the development and 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 execute 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.

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.

RESPONSIBILITIES:

• Adhere to 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 key strategic input into publication planning and review, medical backgrounders, FAQ and standard responses, internal training approach,​ and data dissemination.
• Execute on 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 including Commercial and Development.
• Operate in a fully compliant manner in all internal and external interactions.
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time 

QUALIFICATIONS: 

Education: 

• Advanced degree required (PharmD/PhD/OD/MD) or equivalent degree with relevant therapeutic specialty in the pharmaceutical industry, community, academic or hospital environment required.

Experience: 

• 5+ years of medical affairs experience in the pharmaceutical industry, academia, or equivalent for those holding an advanced degree such as PharmD/OD,etc. Deep therapeutic area expertise strongly preferred.
• 8+ years for those holding a master-level degree.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
• Must possess excellent oral and written English communication skills.
• Ability to exercise judgment and address complex problems and create solutions across multiple projects.
• Pre-launch preparation and launch experience strongly preferred
• Retina experience required, candidates with existing relationships within the retina community strongly preferred
• Global medical affairs experience a plus

Travel: up to 60%, domestic and international

Base salary compensation range: $222,000 - $264,000

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Apply