Director, Clinical Scientist, General Medicine Late Development
The Director, General Medicine will lead and manage the General Medicine Therapeutic Area Functional Center of Excellence for Clinical Scientists. This role provides functional supervision to Clinical Scientists which includes skill development within the four pillars of Medical/Scientific, Operational, Resource Management and People Management. This role identifies and implements best practices in trial management and execution. It is a key contact for General Medicine trial management and execution within the General Medicine TA, and representative of TA Clinical Scientists to GCD organization. This role will be accountable for functional talent and career development of the other Clinical Scientists within General Medicine, including performance management, in collaboration with operational supervisor.
The incumbent will lead a group of Clinical Scientists that work alongside the Medical Directors, and navigate the balance of ensuring projects are delivered at the highest level while allowing scientific mentorship and supervision to emanate primarily from the project clinical lead/study physician. This person will be responsible for setting standards for scientific and operational excellence, forming, building and developing a group of talented and committed Clinical Scientists, collectively delivering timely, scientifically rigorous and high-quality work to meet the needs of the department. The role holder will also be taking on their own projects, modeling best practices with light supervision, and will report to the VP, General Medicine.
- Drive efficient and transparent allocation and assignment of activities to Clinical Scientists according to program priorities and program/trial deliverables to ensure timely completion in accordance with TA objectives.
- Accountable for overall management of Clinical Scientists in collaboration with operational supervisors. Establish annual objectives according to TA priorities and define functional and people objectives.
- Responsible for the development of Clinical Scientist hiring strategic plan, by establishing priority and overseeing the hiring process to ensure talent continuity.
- Participate in the hiring, on-boarding, training and mentoring of new Clinical Scientists. Identify individual training needs to foster high levels of performance, support career development through quality development plans and proactively manage performance issues.
- Serve as knowledge source for clinical trial staff on processes related to trial deliverables and coordinate knowledge sharing. Contributor/reviewer for clinical SOPs and ensure alignment with GCD organization.
- Perform skill-gap analysis and provide recommendation for soft skills training to Talent Management or develop specific training programs for the needs of the TA to improve the medical/scientific, operational and resource management capabilities of staff.
- Develop and implement process standards and tools to achieve excellence in trial operations and management. In collaboration with Global Clinical Operations and key stakeholders, drive implementation globally in a manner that creates consistency, efficiency and with a high level of compliance within GCD across programs.
- May participate in or lead cross-functional GCD process improvement initiatives.
- Advanced degree or equivalent education/degree in life science/healthcare required (PhD/MD/PharmD preferred).
Experience and Required Skills:
- ≥10 years of combined academic and industry scientific experience, with at least 6 years of industry clinical research/development experience.
- ≥4 years people management including leadership/mentoring and talent development experience required, this may include management in a matrix environment.
- Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs.
- Strong management, interpersonal and problem-solving skills.
- Strong communication skills, both verbal and written.
- Extensive knowledge of clinical development process, regulatory requirements and GCP.
- Able to rapidly review and contribute to study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals.
- Proven track in clinical trial process improvements.
- Considerable organizational awareness, including significant experience working cross-functionally and responsibility for internal resource estimation/allocation.