Director, Clinical Operations

Publicly Traded Biopharmaceutical company in Watertown, MA is expanding for their high profile clinical development trials.The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). The Director will be a leader in the organization who knows how to manage a team internally, at our clinical sites, and with our vendors.Responsibilities:

Lead and oversee the strategic planning, implementation and execution of clinical trials across a key immunology program in accordance with project timelines, budget, and quality standardsDevelop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategiesCollaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestonesProvide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the programServe as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standardsEnsure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conductOversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrityContribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reportsIn collaboration with the Head of Clinical Operations, hire, train and develop the Clinical Operations team, fostering a culture of collaboration, accountability, continuous improvement, and operational excellenceWhat skills and experience you’ll bring:BA/BS preferably in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field10+ years of experience in clinical operations within the pharmaceutical or biotechnology industryPrior experience building and leading a team is a plusExpertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GCPAbility to manage multiple competing priorities and adapt to changesStrong communication, interpersonal, and problem solving skillsMust be comfortable working in a fast-paced environmentUnless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.

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