Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
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 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. Direct clinical experience in ophthalmology (MD/OD) preferred.
Experience:
- 7+ years of medical affairs experience in the pharmaceutical industry, academia, or equivalent. Deep ophthalmology therapeutic area expertise strongly preferred.
- 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.
Other Qualifications/Skills:
- 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 strong plus
Travel: up to 60%, domestic and international
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $276,000/yr - $337,000/yr
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
