Sr./Director, Clinical Operations

Position Summary
We are looking for a driven and experienced Sr./Director of Clinical Operations to join our team! S/he will be responsible for providing strategic and hands-on support for Fractyl’s clinical trials during various phases of the company’s growth and expansion. The Sr./Director will be innovative and solutions oriented, and will advise the organization on clinical operations and the related regulatory undertakings, ensuring compliance. S/he will bring to the team an understanding of the clinical and regulatory processes, strong functional expertise, and ability to implement new product registration worldwide. The Sr./Director will successfully lead the clinical team to align the internal activities in support of timely market introduction and competitive positioning for Fractyl’s programs. S/he will also bring to the team sound decisionmaking skills and independent action in support of exceeding business objectives, collaborating closely with crossfunctional groups. S/he will represent the Fractyl team with external parties regularly. A hands-on leader, s/he will manage a team and be experienced at solving complex problems within a high-growth, highly-technical, product-centric environment.

Primary Responsibilities
  • As the subject-matter expert, work closely with the management team on strategic undertakings and plans, directing, implementing and managing all the related clinical operations, outsourcing and direction to ensure
    compliance, scalability and commercialization;
  • Successfully plan, launch and execute clinical studies to meet/exceed business goals;
  • Procure and manage outsourced/external partners (eg. CRO, Labs, Consultants, IRB/ECs) as needed;
  • Oversee and manage overarching patient recruitment plans and related activities in close collaboration with Medical Affairs team;
  • Support the analysis and interpretation of clinical data;
  • Provide clinical input for regulatory strategies and assist in interactions with domestic and global Health
  • Authorities for updates and reporting on clinical trial results;
  • Interact with academic thought leaders, investigators, consultants, and other clinical stakeholders to ensure comprehensiveness and currency in the clinical/medical aspects of programs, advising the company on
    necessary changes, recommending and implementing modifications as appropriate;
  • Build, lead and develop clinical teams, ensuring scalability for future expansion;
  • Prepare and communicate periodic status reports and submission metrics with emphasis on potential impact on product introduction and other business operations timelines;
  • Prepare presentations, and present, internally and externally, inclusive of BOD, investor, and other discussions;
  • Develop appropriate structures for maintaining complete and well-organized records, and direct teams to execute accordingly;
  • Develop and implement programs and SOPs in compliance with GCP regulations and requirements;
  • Oversee and actively manage the clinical financial forecasting and budgets on an ongoing basis;
  • Bring a “can do” spirit to work and deliver on other responsibilities as assigned

Education or Certification Requirements
  • BS in a related business or scientific field
  • Advanced degree a plus

Professional Work Experience
  • A minimum of 8 years clinical operations experience within the biotech industry
  • 3+ years of experience managing clinical operations teams
  • Experience in metabolic disease space ideal
  • Thorough knowledge of clinical operations concepts, practices, and GXP & ICH Guidelines
  • Hands-on experience with procurement and management of external vendors
  • Knowledge of managing through various clinical operations stages (INDs/IDEs filings, regulatory submissions, preparation for commercialization, etc.)
  • Experience in biotech, pharmaceutical and/or medical device industries preferred
  • Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.)

Qualifications and Skills
  • Working knowledge of global medical device development regulations and compliance requirements (US, EU, APAC, etc.) ideal
  • Working experience with regulatory agencies (authorities, staff, etc.)
  • Successful leadership, team building and employee development skills
  • Proven track record of being an effective team player who can engender credibility and confidence internally and externally
  • An able leader who is an effective collaborator working within small environments
  • Flexible and open to change, with an ability to shift priorities and effectively manage change

Other Essentials and Key Success Factors:
  • Successful track record of working in high-growth and dynamic organizations
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
  • Highest levels of professionalism, confidence, personal values and ethical standards

Travel
  • Ability to travel up to 20% globally

The description and requirements outlined above are general; additional requirements may apply.

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