Senior Director, Clinical Development

Cambridge, MA - USA

Yearly Salary: $ 216000 - 270000

Posted on: 15 days ago

Vacancies: 1 Vacancy

Job Summary

Why Sarepta Why Now

The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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: Importance of the Role

Reporting to the Head of Clinical Development the individual in this role will work on multiple late stage clinical programs within Sarepta Therapeutics to provide scientific and strategic leadership for activities in clinical development including multiple anticipated regulatory addition this individual will lead projects under the direction of the Head of Clinical Development assist as needed to support business development and foster innovation and external collaboration. The ideal candidate has a doctorate degree (MD PhD or PharmD) and proven success in clinical development through industry experience and a passion to further the Sarepta pipeline.

The Opportunity to Make a Difference

Supervises one or more direct reports and leads the clinical development team for a product
Leads the design and execution of projects conducted in support of clinical research programs
Leads the clinical study team in protocol development protocol monitoring study reports training documents and other clinical and regulatory documents
Leads the clinical development product team to facilitate clinical development goals and achievement of study quality metrics
Contributes to the organization preparation and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders
Can effectively work across multiple projects and teams
up to date on current information regarding regulations and guidelines for their therapeutic area and scientific advances in the relevant field both internal and external to Sarepta
Cultivates relationships with external partners such as clinical investigators clinicians and scientists in support of innovation and business development
Will assist with the due diligence process as it pertains to business development opportunities
May require travel to field sites internal and external meetings and conferences

More about You

Doctorate degree: MD Ph.D. or Pharm D in a related area
At least 15 years of clinical/research experience including 5 years of industry experience
Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics GCP and regulatory requirements for clinical studies
Ability to make independent timely and appropriate decisions
Ability to work collaboratively in a fast-paced team-based matrix environment
Excellent written and verbal communication skills
Intellectual curiosity flexibility and persistence
High level of organizational and project management skills
Experience interacting with development operations (clinical operations regulatory QA) and clinical investigators

What Now

Were always looking for solution-oriented critical thinkers.

So if youre 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.

#LI-Hybrid

#LI-CM1

This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $216000 - $270000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas compensation philosophy and considers factors including but not limited to education training experience external market conditions criticality of role and internal equity.

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.

Required Experience:

Director

Why Sarepta Why Now The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth thera...

Why Sarepta Why Now

Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

Physical and Emotional Wellness
Financial Wellness
Support for Caregivers

For a full list of our comprehensive benefits see our website: Importance of the Role

The Opportunity to Make a Difference

Supervises one or more direct reports and leads the clinical development team for a product
Leads the design and execution of projects conducted in support of clinical research programs
Leads the clinical study team in protocol development protocol monitoring study reports training documents and other clinical and regulatory documents
Leads the clinical development product team to facilitate clinical development goals and achievement of study quality metrics
Contributes to the organization preparation and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders
Can effectively work across multiple projects and teams
up to date on current information regarding regulations and guidelines for their therapeutic area and scientific advances in the relevant field both internal and external to Sarepta
Cultivates relationships with external partners such as clinical investigators clinicians and scientists in support of innovation and business development
Will assist with the due diligence process as it pertains to business development opportunities
May require travel to field sites internal and external meetings and conferences

More about You

Doctorate degree: MD Ph.D. or Pharm D in a related area
At least 15 years of clinical/research experience including 5 years of industry experience
Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics GCP and regulatory requirements for clinical studies
Ability to make independent timely and appropriate decisions
Ability to work collaboratively in a fast-paced team-based matrix environment
Excellent written and verbal communication skills
Intellectual curiosity flexibility and persistence
High level of organizational and project management skills
Experience interacting with development operations (clinical operations regulatory QA) and clinical investigators

What Now

Were always looking for solution-oriented critical thinkers.

So if youre 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.

#LI-Hybrid

#LI-CM1

This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

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.

Required Experience:

Director

Key Skills

Fundraising
Management Experience
Biotechnology
Clinical Development
Clinical Trials
Research & Development
Training & Development
Grant Writing
Economic Development
Leadership Experience
Public Speaking
Product Development

Apply Now

About Company

Sarepta Therapeutics

We are focused on the development of precision genetic medicines to treat rare neuromuscular and central nervous system diseases. Learn more about Sarepta.

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click