Director, Clinical Scientist, ImmuneInflammatory

Warren, OH - USA

Monthly Salary: $ 205000 - 341600

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

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

To be considered for this role you must have a BS/MS/PhD/PharmD and 10 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. Experience in managing cardiovascular and/or metabolic and/or immune/inflammatory related clinical trials is preferred. 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.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include 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 and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex nationality national or ethnic origin civil status age citizenship status membership of the Traveler community sexual orientation disability genetic information familial status marital or registered civil partnership status pregnancy or parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$205000.00 - $341600.00

Required Experience:

Director

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