- May function as Lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist
- 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
- 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
- Utilizes 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
- Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments. 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
- 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
- Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
- 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
- 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
- Demonstrates initiative, creativity and innovation skills. Directly or indirectly contributes to the development of innovations; Identifies opportunities for process improvements
- Strong direct-line and cross-functional management, interpersonal and Resolves novel problems requiring creative application of advanced skill, training, and education
- Serve as a peer coach learning how to mentor and provides guidance to junior members of department and team members
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Associate Director, Clinical Scientist, Hematology - Bernards, United States - Regeneron Pharmaceuticals, Inc
Description
The Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology 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. Reports to the Director, Clinical Sciences Hematology, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. May be responsible to manage one or more clinical scientists.
As an Associate Director, a typical day may include the following:
This role may be for you:
To be considered for this role, a bachelor's Degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc).≥ 10 years of pharmaceutical clinical drug development experience, including basic knowledge of oncology or hematology therapeutic areas. We are seeking proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrates solid medical writing skills. We need an individual with proven leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs. Other levels considered depending on experience. #Hematology
