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Senior Medical Director, Clinical Development, Ophthalmology
- Job Title
- Senior Medical Director, Clinical Development, Ophthalmology
- Job ID
- 27695461
- Work Remote
- Yes
- Location
- Remote, East Coast - USA,
- Other Location
- Description
-
Mission
Senior Medical Director, Clinical Development, Ophthalmology supports the clinical, scientific, and strategic aspects of AGTC’s ongoing clinical programs. As a Medical Director, you will lead the development of transformational gene therapies to treat ophthalmic diseases, playing a key role in shepherding the drug candidate though development stages. You will be responsible for providing innovative scientific knowledge, skill and technical expertise for assigned clinical programs and projects.
Reporting Relationship
• The Senior Medical Director, Clinical Development, Ophthalmology will report directly to the Global VP, Clinical Development or designee.
Duties and Responsibilities
• Accountable for clinical strategy, including the clinical development plan and coordination of cross-functional execution of clinical strategy by the clinical sub teams.
• Work in collaboration with external and internal experts to generate innovative development plans that create the best balance of time, resource and risk while ensuring the proposed plans align with the overall corporate strategy.
• Represents clinical on the cross-functional program team(s).
• Accountable for clinical input and clinical sections of the Product Development Plan.
• Accountable for clinical project timelines
• Integrate the scientific rationale, regulatory requirements, and commercial goals to build a solid strategic framework for the current and upcoming clinical trials.
• Provide innovative scientific knowledge, skill and technical expertise for clinical programs.
• Work in collaboration with the Global VP, Clinical Development , or designee, internal cross-functional teams, and external experts to develop innovative study designs, and design and draft clinical synopses, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials adequately and appropriately.
• Provide input and guidance on scientific and clinical issues.
• Review medical and clinical data to support patient eligibility decisions.
• Interpret, develop, and prepare medical and scientific data for presentations and study milestones including meetings for Executive Team, Board of Directors, Advisory Boards and Data and Safety Monitoring Committees [DSMC]) and other audiences.
• Accountable for overseeing medical monitoring to clinical studies.
• Leads and/or participates in clinical/medical advisory panels and investigator meetings.
• Contributes as author and provides clinical review of protocols, clinical study reports and publications.
• Remains up to date with current information on regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
• Represents the company in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
• Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
• Accountable for the adherence to Good Clinical Practice, data integrity principles and other key AGTC policy requirements by external and contract partners
• Serve as a key point of contact for the clinical operations personnel, clinical trial sites and CROs for clinical science questions.
• Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions.
• Support the Global VP, Clinical Development in the publication strategy planning and execution including coordinating and overseeing medical writing and statistics vendors, and KOL and Investigator speaker preparation for presentation of AGTC data results.
• Assist the Safety & Pharmacovigilance team with the design and execution of the Safety Management Plan, medical coding, and relevant safety data reviews and queries as appropriate.
• Have extensive knowledge of the pharmaceutical/biotech industry and FDA IND, and ICH, regulations. Maintain active involvement in biotechnology, medical, and clinical organizations to ensure up-to-date knowledge of current and future relevant disease indications, treatment guidelines, and industry trends.
• May have direct reports
• Other duties as assigned.
• This job description is subject to change at any time.
Educational Qualifications
• Advanced degree required (PharmD, PhD, DO, or MD)
Additional Qualifications
• Ten (10) plus years of relevant scientific, clinical and/or drug development experience, seven (7) plus years of progressive responsibilities in drug development, and a proven track record for clinical and scientific leadership in drug development are ideal. Ophthalmology and gene therapy experience strongly preferred.
• Excellent leadership skills including ability to lead directly and by influence.
• Strong problem solving, conflict resolution, and analytical skills.
• Ability to synthesize and interpret complex information
• High level of integrity, autonomy, and motivation
• Quality focused and well-organized
• Excellent written and verbal communication skills
• Demonstrated strategic and critical thinking
• Experience working with biotechnology products and previous experience in ophthalmology clinical trials preferred
• In-depth understanding of GCP and FDA IND regulations
• Ability to effectively manage multiple tasks and projects and adapt to the changing needs of the organization.
• Innate collaborative attitude, with demonstrated ability to work effectively in a fast-paced, small company environment.
• Understanding/working knowledge of Zoom, and Microsoft Word, Excel, PowerPoint
Physical Requirements
• Physical demands: (check one)
☒ sedentary (< 10 lbs.)
☐ light work (< 20 lbs.)
☐ medium work (< 50 lbs.)
☐ heavy work (< 100 lbs.)
☐ very heavy work (> 100 lbs.)
• Physical activity: (check all that apply)
☒repetitive motion
☐ balancing
☐stooping
☐lifting
☐climbing
☐kneeling/crouching
☐crawling
☐reaching
☒standing
☒ typing/grasping
☒walking
☐pushing/pulling
☒hearing
• Visual acuity: reading, writing, preparing/analyzing data
• Working conditions: indoor office environment
Supervisor Responsibilities
• This position requires previous supervisory experience.
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