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Executive Medical Director
Company | Sarepta |
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Location | Cambridge, MA, USA |
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Salary | $304000 – $380000 |
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Type | Full-Time |
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Degrees | PhD, MD |
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Experience Level | Expert or higher |
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Requirements
- MD or PhD required, subspecialty training in neurology or gene therapy is preferred.
- 10+ years of hands on pharmaceutical or biotech experience in clinical development; Rare/orphan diseases preferred, but not required.
- Prior IND/CTA and/or NDA/MAA filing experience.
- In depth knowledge of drug development process and oversight of clinical trials.
- Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics.
- Excellent skills in engaging with internal and external stakeholders, including regulatory agencies, industry partners, and senior corporate leadership.
- Excellent interpersonal, written, verbal and visual communication skills.
- Proven ability to successfully manage multiple tasks and prioritize accordingly.
- Proven ability to interact cross-functionally with strong presentation skills.
- Willingness to travel.
- Recognized by former peers, colleagues, managers, and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.
Responsibilities
- Functioning as a strategic leader within the function, overseeing multiple programs and/or a therapy area.
- Leading a team to create and execute integrated development plans across these programs that provide strategic priorities and solutions to program challenges.
- Partner with cross-functional leaders and governance bodies to provide leadership and direction to support the integrated development plan and drive cross-functional decision making.
- Establish and maintain positive relationships with clinical trial investigators/physicians, KOL’s and clinical advisors through independent collaborations and scientific meetings.
- Provide expertise and leadership to support protocol development, regulatory agency engagements, and documents including INDs and BLAs.
- Supports key business initiatives including providing strategic input on compounds in development and assessment of their development strategies.
- Provide medical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development.
- Maintain responsibility for the clinical development budget related to their programs or therapy area.
- Lead innovative initiatives to enhance the company’s competitive edge in clinical development.
Preferred Qualifications
- Subspecialty training in neurology or gene therapy is preferred.
- Rare/orphan diseases experience preferred, but not required.