Summary of the Essential Functions of the Job :

• Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality

• Ensure operational activities and tactical execution are linked to Program strategy

• Implement strategies and tactics to proactively identify, monitor and resolve project and program risks. Collaborate with cross-functional teams and senior management to resolve complex issues promptly and effectively

• Provide a continuously updated and balanced appraisal of the project and program status, including risk, cost, and value to stakeholders and senior management. Evaluate, highlight, and escalate unresolved issues, potential barriers to program progression and resource constraints

• Assists in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report, and other regulatory documents

• Oversee the development of trial(s) timelines, budget, and priorities

• Establish key performance indicators and metrics for the Clinical Operations 

department and use Change Management skills to ensure they are translated into standards

• Ensure robust Sponsor oversight of Service Providers and compliance with FDA regulations, GCP, ICH, and Company SOPs for all clinical operations activities 

• Serve as a member of the Clinical Operations Leadership Team (COLT), working in partnership with peers and the VP, Clinical Operations to set the strategy and direction for the department

• When needed, serve as the delegate for the VP, Clinical Operations at strategic meetings. Serve as Signatory coverage, assuming the VP’s Grant of Authority for signing contracts and Agreements

• Support business planning as needed, including demand and resource management. Set appropriate and rational headcount/manpower forecasts to support the portfolio of clinical trials

• Support annual Strategic Planning exercise, as needed, including setting internal and external (clinical trial) budget forecasts

• Participate in prioritization exercises to rationalize the clinical projects and non-project initiatives managed on an annual basis

• Collaboratively work with other Functional Areas, as well as cross-functional teams to ensure timely delivery of project deliverables with consistent high performance and quality of work

• Lead the development and optimization of processes for Clinical Operations. Proactively assess and evaluate the need for new/updated processes and manage implementation of process improvement initiatives

• Provide input into strategies for outsourcing partnerships. Participate in the vendor selection and review process. Lead vendor and Site contracting and manage change order processes as needed

• Strong vendor management to hold Service Providers accountable for performance. Serve as key contributor on Sponsor/Service Provider Operational Governance Committee

• Ensure management of clinical study budgets and specifications so that project/study goals are achieved within scope. Assure study priorities are satisfied and budgets are adhered to. Ensure tracking, financial, and resourcing tools are effectively utilized. Support identification and resolution of budget and resourcing issues

• Participate in the development of training programs and manage training initiatives for direct reports. Collaborate with training resources. Document requirements and report completion

• Responsible for objective setting and performance review for direct reports. Identify and address performance issues and training needs at a functional and departmental level. Serve as a resource and mentor to direct reports and other less experienced staff. 

Minimum Requirements:

• BS/BA degree or a relevant degree with strong emphasis on science

• Minimum of four years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials

• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience 

• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

• Demonstrated leadership and problem-solving skills

• Experience in executing a wide range of clinical trial activities (from initiation to clinical study report) 

• Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment

• Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently

• Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships

• Minimum of a BSN/RN/BA or BS in a related field. MBA or advanced degree in a scientific discipline is desirable

• 10 years of progressive R&D Clinical Operations experience at a biotech, pharmaceutical company or clinical CRO; 7 years leading teams; 5 years in a Leadership/Strategic role

• Phase 1-4 clinical trial experience required. Experience running pivotal, multi-regional/global clinical trials. Experience leading project operational teams through all stages of the trial (forecasting/planning, start-up, conduct, close-out). Previous monitoring, study coordination, data management and/or clinical project management experience, including vendor/CRO management is required

• Previous supervisory/line management experience

• Strong knowledge of the end-to-end pharmaceutical drug development and commercialization process, including hands-on experience in the successful planning and execution or contribution to complex Health Authority interactions such as End-Of-Phase 2, Advisory Committee meetings, IND, sNDA/NDA submissions, and approvals

• Scientifically and clinically astute with learning agility, translating to a demonstrated ability to develop a deep understanding of therapeutic areas and optimal development strategies

• Advanced knowledge of cGCP, ICH, FDA and EMEA regulatory requirements

• Strong project management, analytical and problem-solving skills.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.