Sr. Medical Director - Gene Therapy (18-221)

Sarepta Therapeutics Cambridge , MA 02138

Posted 4 months ago

The Company:

Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit www.sarepta.com.

The Position:

The Executive Medical Director is responsible for assisting with the advancement of assigned gene therapy clinical development programs. The Executive Medical Director supports the strategic, clinical and regulatory aspects of assigned programs and serves as the Medical Monitor for assigned clinical trials in DMD, ensuring compliance with ICH/GCP and federal regulations.

Primary responsibilities include:

  • Provide Medical and Clinical Development expertise and leadership to assigned gene therapyclinical development programs

  • Design and draft clinical development plans, protocol synopses, clinical trial protocols and protocol amendments. Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues

  • Partner with Clinical Operations and provide leadership and direction to clinical project teams

  • Establish and maintain positive relationships with clinical trial investigators/physicians, KOL's and clinical advisors through independent collaborations and scientific meetings

  • Support Data Monitoring Committee's during the conduct of clinical trials

  • Provide clinical development support for regulatory agency engagements and documents including INDs and BLAs

  • Provide strategic input on compounds in development and propose clinical development strategies

  • Provide medical expertise as needed for business development initiatives

  • Provide medical and scientific expertise to preclinical discovery groups for compounds that are in preclinical development

Education and Skills Requirements:

  • MD required, subspecialty training in neurology or pediatrics is preferred

  • 8+ years of hands on pharmaceutical or biotech experience in clinical development. Rare/orphan diseases preferred, but not required

  • Strong immunology and/or gene therapy background is highly preferred

  • 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 interpersonal, written, verbal and visual communication skills

  • Proven ability to successfully manage multiple tasks and prioritize accordingly

  • Professional and pleasant demeanor

  • 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

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director/ Sr Director Global Marketing Gene Therapy (Duchenne Muscular Dystrophy) (18256)

Sarepta Therapeutics

Posted 1 week ago

VIEW JOBS 12/5/2018 12:00:00 AM 2019-03-05T00:00 The Company: Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit www.sarepta.com. The Position: Join Sarepta's team by contributing to the overall success of our novel gene therapy division. The Director, Global Marketing: Gene Therapy reports to the Executive Director, Global Strategic Marketing and will be responsible for the development of the Global Brand Strategy and plan for Gene Therapy global strategic disease awareness communications for HCP and patients/caregivers to ensure market preparation. The Director, Global Marketing: Gene Therapy will work closely with the Gene Therapy Global Asset Leads (GAT) and will lead the Brand Team (GBT) working closely with Medical Affairs, Market Access, Commercial Operations, Patient Advocacy, Market Insights and the European and International Heads, to develop and execute clear, concise and actionable strategic and tactical plans to optimize the launch and commercial success of Sarepta's Gene Therapy in Duchenne Muscular Dystrophy (DMD) and additional disease areas. This is an opportunity to work with Sarepta, realizing the promise of precision genetic medicines for the treatment of rare diseases. Primary Responsibilities Include: * Develop strategic and tactical plan in collaboration with the global commercial lead and gene therapy brand team * Lead the Gene Therapy Global Brand Team. * Build a global brand including concept/category nomenclature development, competitive analysis, and global segmentation, brand positioning, verbal and visual branding development. * Lead message platform development to drive disease awareness and education efforts in DMD unmet need and improved in time diagnosis * Design and implement multi-channel communications and programs * Drive global market researches to define objectives to understand and provide insights into launch preparation efforts as it relates to the global market landscape for DMD and other indications * Lead competitive tracking efforts to keep the team current on emerging competitors and related data and positioning * Lead strategy and content for HCP, patient, and digital (including e-marketing and social media) channels and manage external agencies in this effort for Disease Education * Support the development and adaption of gene therapy messaging for patients across all Sarepta gene therapies – ensuring the science is accessible and easily understood. * Liaise with Regional teams to coordinate execution and ensure local insights are integrated into global materials/ core brand assets * Manage agency partners on market research efforts, creation of marketing materials, and channel strategy for optimal execution of communication materials * Drive development of disease awareness and marketing materials through the medical, regulatory, legal review process and integrate feedback accordingly to ensure compliant execution * Interact with key opinion leaders, the patient community, and other relevant stakeholders such as our centers of excellence in collaborations with Medical Affairs, Patient Advocacy and Opinion Leader Marketing. * Manage timelines, budgets, and resources: includes ensuring timelines, budget, and resources square up to commercial and corporate objectives Education and Skills Requirements: * Bachelors degree in a life science; MBA, or advanced degree, preferred * 6-8 years' experience in a strategic / global marketing role * Must be able to see and communicate the big picture from lots of data and information and drive to actionable insights * Experience in high science, competitive market required. * Global product launch experience preferred * Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities * Enthusiasm for working in a high-science environment * Solutions-oriented, strong analytical and presentation skills * Excellent verbal and written communication skills * Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Sarepta Therapeutics Cambridge MA

Sr. Medical Director - Gene Therapy (18-221)

Sarepta Therapeutics