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.
- 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.
- Ensure study manager competencies are present and continuously improving.
- Manage study manager workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies.
- Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development and models inclusivity to ensure diverse voices and ideas are heard and considered
- Serves as mentor for study managers and others in the CDDA.
- 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
- Works closely with the CTPMs to ensure efficient and on-time execution of trials and enables aggregation / roll-up of key trial metrics to track the status of the portfolio.
- Understands and applies core project management capabilities, including impact chain methodology and usage of its functionality to manage program/trial
- Partners across the CDDA to ensure effective transition of the complete clinical trial package (scope, timeline, budget and risk management) through trial execution and clinical delivery.
- Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution.
- Utilize regulatory and process knowledge to drive decision-making
- Establishes and manages expectations of external partner relationships, performance and delivery (i.e. CRO, Alliances and Joint Ventures).
- Align CDDA resources based on portfolio prioritization while demonstrating flexibility across therapeutic areas.
- Ensure a compliance culture and state of inspection readiness of TMF records created, maintained and finalized by CD personnel.
- Models judgement-based decision making to navigate compliance and quality requirements
- 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.
- Bachelors 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)
- Project Management certification (e.g., PMP)
- Prior experience in working with external business partners (e.g., CRO, Alliance, Joint Venture)
- Prior submission and inspection experience
- Prior experience with the management of business plans
- Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
- Able to influence others without direct authority
- Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence
- Travel may be required