Title: Head of Clinical Operations
Location: Waltham, MA
Entasis is seeking an experienced and effective leader to play a very significant role in driving innovative products from early and late-stage discovery through product approval. The Head, Clinical Operations will report to the Chief Medical Officer and will play a key hands-on leadership role in the planning and execution of all clinical development programs and studies managing personnel and activities across the organization. This will involve managing a small team and optimizing an outsourced model across a portfolio of assets spanning several infectious diseases. Primary responsibility will be to ensure that clinical operation deliverables of quality, time and budget across the portfolio are met. This will involve managing and mentoring a small multifunctional team and developing an effective outsourcing model. This role will have regular interaction with senior leaders and will communicate and influence with stakeholders across the company.
- Be a key individual in the senior leadership of the clinical development group, reporting to the CMO. Mange the clinical operations group and provide input on operational activities to support short, medium, and long term planning.
- Manage the clinical operations group to support overall set-up, execution and delivery of multiple global clinical programs, including project planning, budget and resource management, CRO and vendor management.
- Develop clinical operational plan, including timelines based on programs CDP
- Lead both internal and external clinical operations teams to ensure the successful conduct of clinical trials in accordance with state/federal regulations, CGP, ICH and internal SOPs.
- Build, support and leverage multi-functional operations team to deliver on company, department and program, and study goals. Performance management, development and optimal leveraging of team.
- Regular communication of program and study plans, status, risks and contingency plans with senior management and key stakeholders.
- Represent operations either directly or through a designee on Core Program Team and/or manage and mentor staff. Ensure Study Management Teams across the portfolio are effective in the planning and delivery of all studies in line with program and company goals of quality, timelines, and budget. Ensure robust risk mitigation plans are developed across the portfolio.
- Evaluate and implement optimal outsourcing models to deliver on the portfolio. Lead the operations team in the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution and ensure proactive management of CRO performance across the operations team and functions.
- Develop and implement processes across all operations functions and ensure proactive inspection readiness. Ensure adherence to ICH GCP and applicable guidelines and regulations.
- Ensure medical writing processes are in place for creation of good quality clinical documents. Contribute to authoring clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND submission documents, responses to Health Authorities’ questions.
- Collaborate with CMC/clinical suppliers to provide drug supply assumptions and contribute to design and packaging of supplies for clinical programs and trials.
- 5 – 7 years of experience in clinical operations in a pharmaceutical company or biotech firm. Experience across all phases of clinical development. Proven ability to lead a multidisciplinary team toward a successful outcome.
- Strong project management and communication skills. Clinically/scientifically savvy; degree in scientific or clinical field is preferred.
- Thorough understanding of country-specific, FDA (and equivalent), ICH and GCP guidelines as well as cross-functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and regulatory affairs.
- Excellent interpersonal, communication, negotiation and influencing skills.
- Experience having managed significant accelerations and challenges in clinical programs is desirable.
- Comfortable working with Senior Executive Team.