Director, Clinical Scientist, Immune/Inflammatory

Regeneron Pharmaceuticals•Warren, MI

About The Position

The Director Clinical Scientist 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. The Director 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 Director reports to the Senior Director Clinical Scientist and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Director, a typical day may include the following: May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist Member of the Clinical Study Team and Global Clinical SubTeam 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 advanced 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 Applies advanced 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 independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of clinical data review plan and medical monitoring plans; ensures execution where appropriate for assigned studies/program Identifies areas of potential inconsistent data review across assigned clinical research program(s) and implements solutions and/or escalates as appropriate May serve as a peer coach and/or mentor and provides guidance to junior members of department and cross-functional team members as appropriate This role may be for you if: 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 department and may influence across functionally Demonstrates exceptional initiative, creativity and innovation skills. Directly contributes to the development of innovations. Identifies opportunities to initiate operational changes Uses professional concepts to evaluate novel problems and develop novel solutions for critical organization-wide issues and broad design matters Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs Strong cross-functional management, interpersonal and problem-solving skills Considerable organizational awareness, including significant experience working cross-functionally

Requirements

BS/MS/PhD/PharmD and ≥ 10 years of pharmaceutical clinical drug development experience.
Demonstrates advanced knowledge of the global drug development process, Good Clinical Practice, complex study design, clinical research methodology & medical writing skills.
We are seeking extensive knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
Proven track record in clinical trial process improvements.
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 department and may influence across functionally
Demonstrates exceptional initiative, creativity and innovation skills. Directly contributes to the development of innovations. Identifies opportunities to initiate operational changes
Uses professional concepts to evaluate novel problems and develop novel solutions for critical organization-wide issues and broad design matters
Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs
Strong cross-functional management, interpersonal and problem-solving skills
Considerable organizational awareness, including significant experience working cross-functionally

Nice To Haves

Experience in managing cardiovascular and/or metabolic and/or immune/inflammatory related clinical trials is preferred.

Responsibilities

May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist
Member of the Clinical Study Team and Global Clinical SubTeam
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 advanced 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
Applies advanced 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 independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently
Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders
Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of clinical data review plan and medical monitoring plans; ensures execution where appropriate for assigned studies/program
Identifies areas of potential inconsistent data review across assigned clinical research program(s) and implements solutions and/or escalates as appropriate
May serve as a peer coach and/or mentor and provides guidance to junior members of department and cross-functional team members as appropriate

Benefits

comprehensive benefits, which vary by location
health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)
reasonable accommodation to the known disabilities or chronic illnesses