Sr. Director, Clinical Operations
HAYS

Job Info

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Biopharmaceutical Company is seeking a Sr. Director, Clinical Operations in Cambridge, MA.

Role Description
The Sr. Director, Clinical Operations Study Management is an operational and drug development subject matter expert accountable for the delivery of trials within their assigned portfolio of clinical trials. He/she will partner with other Clinical Operations and Expertise Area leaders. He/she must be able to collaborate, influence and lead discussions with key leaders/stakeholders to determine program priorities and will define and implement resourcing and execution strategies. He/she will provide strategic and operations leadership across clinical projects and contribute to defining the overall program strategy. He/she may also provide strategic program direction and oversight of clinical research activities, including clinical development plans, study design, protocol development, study and operational feasibility and risk assessment, key CRO relationships, KOL relationships, throughout all phases of clinical development. The Sr. Director, Clinical Operations Study Management is an effective team leader. He/she is responsible for the talent development, provides line management and supervision of team members in his/her group. He/she is responsible for building clinical operations, therapeutic area and technical skills within his/her group to ensure patient safety, quality clinical trial execution and effective delivery of trials. He/she is also a member of the Clinical Operations Leadership team and as such supports and influences the direction of the Clinical Operations group.

Sr. Director, Clinical Operations Study Management is accountable for the delivery of clinical trials within his/her assigned portfolio and for ensuring appropriate management of study vendors/CROs. He/she will collaborate with internal stakeholders on the oversight of vendors/CROs. He/she will assist in resolving or escalating issues as needed. He/she is responsible to ensure the clinical trials in their group are adequately resourced, sets priorities, manages operational plans and budgets. The Sr. Director, Clinical Operations Study Management serves as an expert in clinical operations processes and is responsible for developing and sharing best practices within his/her team and across the Clinical Operations organization. He/she will work with other Clinical Operations and Expertise Area leaders to formulate strategies, standards, processes and best practices to be implemented for the benefit across Clinical Operations. The Sr. Director, Clinical Operations Study Management ensures strong interaction with local country, medical affairs teams/regional medical groups and other strategic partners as needed for the successful delivery of clinical trials

Skills & Requirements
• Partners directly with or guides internal staff along with the CRO team(s) to collaborate with preclinical (pharmacology, toxicology, drug safety and metabolism), regulatory affairs, medical monitoring, biometrics, medical affairs, pharmacovigilance, and/or medical writing to develop drug development strategies, protocol and study designs, and other key study and program deliverables. Has overall accountability for the development of the Clinical Operations study/project strategy for assigned projects.
• Communicates program strategy, goals and priorities across a wide range of audiences ensuring that they are understood and supported
• Active participation as a member of the Clinical Operations Leadership Team in driving strategy and team execution.
• Participates in protocol, IB, ICF, Regulatory submission documents, CRF, CSR, abstract and publication development and review and provides direction to junior staff to manage the content and process, as necessary.
• Effectively discusses and presents study data across the company and with development partners; collaborates with clinical scientists, medical writers and investigators to write, present and/or publish data.
• Maintains appropriate therapeutic area technical and working knowledge of scientific and clinical operations developments.
• Responsible for the guidance of clinical staff, including hiring, performance management and ongoing coaching. If UK based, participates as member of UK office leadership team under UK General Manager (GM) supporting the development and continue growth of the UK team whilst also ensuring alignment with UK HQ counterparts.
• Develops and implements strategies to maximize study management competency and skills related to clinical operations trial delivery.
• Responsible for shaping the Clinical Operations team culture including the retention and engagement of team members.
• Leads teams towards departmental and project productivity and quality metrics and provides financial and management accountability.
• Manages the recruitment and performance of junior staff to support and guide them to improved strategic drug development operational efficiency, effectiveness at prioritization, and problem identification and solving.
• Acts as point of contact for leadership including resolution or escalation of issues as appropriate.
• Participates in and provides direction on development of Clinical Operations Plans, Clinical Research Organization (CRO) outsourcing strategy, and key performance indicators (KPIs) with CRO and reviews KPIs during projects.
• Oversees the development of tracking tools and guides staff on effective management of project teams, project budgets, study timelines, and deliverables.
• Guides teams and identifies and reports potential program issues and resource deficiencies effectively and in a timely manner and implements corrective action.
• Accountable to deliver excellence in clinical operations study management for a portfolio of clinical trials, ensuring the trials progress in accordance with agreed plans.
• Collaborates with vendor/CRO partners, internal groups in the development of and compliance with robust inspection readiness plans to ensure high quality clinical trial conduct and data integrity.
• Partners with Quality Assurance and Clinical Operations Oversight teams to ensure team, vendor/CRO partners consistently deliver data which supports regulatory requirements.
• Actively participates and/or leads in the development of the Clinical Operation department's vision, standards and successful implementation of process improvements and change.
• Instills a culture of continuous improvement; acts as a change champion and effectively leads change
• Maintain awareness of biopharmaceutical business, operational trends and external organizational developments to help define future strategic direction.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

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Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information. #1115901