his position will lead one or more Clinical Affairs teams dedicated to clinical development of Exact Sciences’ products. This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Director will manage, execute and report on clinical study progress; and will provide leadership to members of multidisciplinary project teams, internally and externally.
Essential Duties and Responsibilities
Include but are not limited to the following:
- Act as a customer advocate throughout the product lifecycle.
- Understand and support global study goals including site recruitment, patient recruitment, marketing and PR for clinical development programs, as appropriate.
- Oversee implementation of approved clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies.
- Lead the coordination with Clinical Operations, Marketing, Research & Development and Operations management to identify goals and scope of clinical study projects and programs. Accountable for clinical program scope and timelines.
- Leads and manages resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, central IRBs, and contractual agreements.
- Identify, operationalize and oversee vendor relationships. Accountable for vendor performance.
- Assume primary accountability for assigned clinical research programs and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities.
- Ensure the development, maintenance and adherence to clinical processes. Contribute to the identification of gaps and solutions.
- Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required.
- Ensure operational and regulatory integrity of studies and participates in FDA or other regulatory authority inspections, as needed.
- Lead the efforts to ensure that team members are trained appropriately to ensure proper study conduct.
- Accountable for department resource planning, FTE and contractor allocation.
- Oversight of monthly, quarterly and annual study and department budgets, partnering with Finance and Accounting as appropriate.
- Manage the tasks that are not associated with in-life component of studies including, but not limited to: development of study specific databases, statistical analysis and report writing.
- Serve as a liaison between clients and internal teams to ensure project specific information and ongoing updates are proactively communicated.
- Serve as the primary leader for a diverse team with specialized expertise.
- Lead initiatives to improve systems, processes, procedures to drive quality into Clinical Affairs strategy.
- Utilize strong coaching/counselling skills to support performance management.
- Able to work effectively cross-functionally in project team situations, influence and collaborate with stakeholders as well as work independently leading teams forward with a clear vision.
- Able to make decisions based on data and lead the teams through ambiguous situations. Attend off site-meetings and conferences, as needed.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to sit for an extended period of time.
- Ability to stand for extended periods of time and up to 6 hours at a time.
- Ability to travel (by land and air), both domestically and internationally, on occasion.
- Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
- Constant walking or motion to coordinate work and interact with co-workers.
- Ability to lift and move up to 40 pounds on an occasional basis.
- Bachelor’s degree in health sciences, or a related field preferred.
- 12+ years of experience in clinical research.
- 10+ years of clinical project/study management experience.
- 10+ years of experience managing direct reports or project team members in a clinical research environment.
- Certification preferred, CCRC, CCRA, CCRP.
- Demonstrated experience leading and managing project team personnel.
- Experience with CTMS, EDC, eTMF, and sample management systems.
- Experience in IVD studies and lab site management preferred.
- Experience leading clinical study teams through the start-up, study conduct, close out, data management, and report writing of clinical studies.
- Experience writing, reviewing and editing protocols and clinical study reports.
- Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process including IDE, PMA, and 510(k).
- Demonstrates problem-solving and interpersonal Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
- Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.
- Ability to effectively communicate to all levels within the company and thrive in a fast-paced, ever changing environment.
- Ability to comprehend procedures, processes and experimental designs to provide guidance and support to teams.
- Excellent analytical skills.
- Ability to course correct when issues arise with strong tactical and clear execution plans.
- Ability to work independently and manage multiple timelines, while maintaining the team focus.