HEAD OF CLINICAL OPERATIONS
Commense Health is pioneering a deep understanding of the microbiome early in life and its fundamental role in promoting a lifetime of health. Drawing insights from natural exposures to beneficial microbes, Commense is developing approaches to guide the priming, seeding, and maintaining of the microbiome in infants and children. Co-founded by PureTech Health (“PureTech,” LSE: PRTC) and working with the world’s leading microbiome scientists, physicians, and product developers, Commense is developing a novel category of products to address critical unmet needs in pediatric populations.
The Head of Clinical Operations will be a key member of Commense’s expanding development team, and will play a critical role in shaping Commense’s clinical strategy, lead the clinical programs, and manage clinically-focused partnerships with industry and academia. Candidate must have a demonstrated ability to manage important relationships with key external stakeholders, strategic partners, and vendors.
- Manage clinical programs, including study management, design, budget, communications, documentation, reports and timeline creation.
- Lead the evaluation, selection and management of clinically-focused strategic alliances (e.g., KOLs, Principal Investigators, etc.) to meet Commense’s strategic and operational goals.
- Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.
- Build, manage and lead a team of clinical operations staff.
- Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary.
- Responsible for infrastructure build for lead clinical trial programs, including inspection readiness.
- Partner with CMC/clinical suppliers to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials.
- Participate in preparation of regulatory filings (e.g., IND, clinical, etc.) as needed, with the possibility of leading or taking on a large role.
- Integrate and interpret clinical data across studies, and contributing significantly to the formulation of recommendations for response to evolving clinical, regulatory, commercial data across functions.
- As a member of the R&D Leadership team, provide oversight and guidance to all R&D activities in the company.
- Minimum of a Bachelors degree in Biomedical or Health Care related specialty.
- Minimum 5 years of experience and proven track record of leading and delivering clinical studies/programs.
- Excellent understanding of clinical study design and drug development.
- Successful product development leading to product approvals.
- Expertise in the microbiome or microbiology is a distinct advantage.
- Prior startup experience a plus.