Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Associate Director reports to the RGM CDU Senior Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.
As an Associate Director, a typical day may include:
1. May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist
2. Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
3. Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
4. Applies proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature
5. Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
6. Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support
7. Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
8. Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators
9. Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
10. Applies proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
11. Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program
12. May serve as a peer coach learning how to mentor and provides guidance to junior members of department and cross-functional team members as appropriate
This role may be for you if:
13. Ability to lead activities within a matrix environment; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to Influence within team and may influence across functionally
14. Demonstrates initiative, creativity and innovation skills. Directly or indirectly contributes to the development of innovations; Identifies opportunities for process improvements
15. Resolves novel problems requiring creative application of advanced skill, training, and education
16. Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs
17. Strong cross-functional management, interpersonal and problem-solving skills
18. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
19. Proven track in clinical trial process improvements
20. Considerable organizational awareness, including substantial experience working cross-functionally
To be considered, you must have a Bachelor’s Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) and ≥ 10 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. Demonstrate proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrates solid medical writing skills.