What are the responsibilities and job description for the Executive Medical Director position at Sarepta Therapeutics?
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
The Executive Medical Director is responsible for strategic leadership within the clinical development function and may be asked to lead a therapy area spanning multiple programs. The individual is responsible for defining strategic priorities for the programs/therapy area and integrating cross-functional input in order to develop and execute the integrated development plans. The individual must have strong team leadership skills and have deep knowledge of the clinical drug development process, spanning early/translational phases through to registration. The individual engages with key stakeholders to influence clinical practices and policies, manages resources across programs, and may deputize for the Vice-President of Clinical Development in governance and strategic meetings.The Opportunity to Make a Difference
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.
More about You
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.
What Now?
We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
Salary : $304,000 - $380,000
