Clinical Development Senior Manager
The Clinical Development Senior Manager (CDM) is responsible for the recruitment, retention and resource assignment of the Consultants, Associates, and Assistants (study managers) managing trials in the Clinical Development (CD) organization.
The CDM provides leadership, direction, and technical/ process expertise to the study managers. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives Clinical Design, Delivery, & Analytics (CDDA) team collaboration to the achievement of goals and objectives. The CDM leads the clinical teams responsible for the execution and delivery of the clinical package.
The CDM supports execution of the integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team. To achieve this goal, the CDM uses their clinical development expertise and effectively partners with the Clinical Development Advisor (CDA), Asset Team and broader Clinical Design, Delivery, & Analytics functions.
Role Responsibilities: (For information please reach out directly)
- Recruit, develop, and retain a diverse and highly capable workforce
- Ensure robust individual training plans and timely completion of required training for direct reports.
- Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making.
- As applicable, support clinical development of assigned asset(s) from strategy and profile development through submission, inspection, approval and post-launch support.
- Demonstrate strong business acumen, problem-solving skills, and learning agility to help teams plan for contingencies, and adjust to change.
- Manage program-level activities including management of risk plans and oversight of budget planning, monitoring, and control, and supports the accountabilities of the CDA
Responsible for continuous improvement and shared learning in the following clinical development areas: study development, start-up, delivery, maintenance, and close-out processes, and collaborates with process owners in the spirit of streamlining, efficiency, and effectiveness of conducting clinical trials and non-trial work
- Bachelor’s degree, preferably in a scientific or health-related field
- Previous experience, at least 5 years in a lead role in the pharmaceutical industry and/or clinical development
- Must understand clinical development processes and the interdependencies of various tasks that require coordination among cross-functional team members and third parties
- Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines
- Strong communication skills; able to communicate clearly and succinctly with team members and leadership
- Must be capable of managing staff virtually and across geographies/cultures
- Proven ability to coach and develop others.
- Ability to embrace the diversity of thought to model innovative behaviors (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)
For a confidential discussion and more information on the role, please contact Josh Barnes.