Executive Director, Clinical Research Scientist
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.
Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs as assigned by phase or therapeutic area.
Essential Functions of the Job (Key responsibilities)Design and author protocols for clinical studiesResponsible for providing clinical input into eCRF design, SAP, and TLFs.
Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
Provide clinical updates on assigned compounds/programs to Sr.
management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committeesLead or co-lead the ICF risk language across a compound to ensure a consistent approachContribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plansMaintain alignment with the asset Global Lead, Operational Asset Lead, and Global Product Strategy LeadLead, co-lead, and contribute to the review of clinical sections of documents such as IND, IND amendments, Investigator Brochures, oncology unique CRFs, Annual Reports and other Health Authority submissionsManage relevant issue escalation to resolution, as items arise on Clinical Development ProgramsCoordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of contentAttend and present at various meetings with internal and external stakeholders (eg, investigator meetings, scientific advisory boards, etc)Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategyClinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compoundsContribute or lead process improvement initiativesProvide mentoring, leadership, guidance, and clinical science expertise to Incyte personnel to enable proper decision-makingMaintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interestLiaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as neededLiaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicableConsult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgetsQualifications (Minimal acceptable level of education, work experience, and competency)Degree in scientific/life-sciences field such as Masters, Pharm.
D, or Ph.
D/EdD degree preferredMinimum of 10 years of experience in research with at least 6 years of drug development experience are required.
Alternative drug development experience will be considered.
Prior Oncology Drug Development experience requiredGlobal oncology trial experience and Health Authority experience are highly preferredExcellent written and oral communication skillsStrong analytical and strategic abilityAbility to work independently and to multi-task large projects or compounds, ability to change pace and tasks as needed, and to work in a fast-paced environmentKnowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelinesAbility to manage direct reports a plusAbility to lead and/or be a proven leader in a line function responsibility, as well as having an ability to influence in a matrix global environmentHave proven ability to drive decisions and manage in difficult business situationsAbility to accommodate up to 20% travel or as business dictates
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your PrivacyLearn more at Recommended Skills Advertising Analytical Business Process Improvement Clinical Research Clinical Works Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs as assigned by phase or therapeutic area.
Essential Functions of the Job (Key responsibilities)Design and author protocols for clinical studiesResponsible for providing clinical input into eCRF design, SAP, and TLFs.
Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
Provide clinical updates on assigned compounds/programs to Sr.
management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committeesLead or co-lead the ICF risk language across a compound to ensure a consistent approachContribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plansMaintain alignment with the asset Global Lead, Operational Asset Lead, and Global Product Strategy LeadLead, co-lead, and contribute to the review of clinical sections of documents such as IND, IND amendments, Investigator Brochures, oncology unique CRFs, Annual Reports and other Health Authority submissionsManage relevant issue escalation to resolution, as items arise on Clinical Development ProgramsCoordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of contentAttend and present at various meetings with internal and external stakeholders (eg, investigator meetings, scientific advisory boards, etc)Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategyClinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compoundsContribute or lead process improvement initiativesProvide mentoring, leadership, guidance, and clinical science expertise to Incyte personnel to enable proper decision-makingMaintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interestLiaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as neededLiaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicableConsult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgetsQualifications (Minimal acceptable level of education, work experience, and competency)Degree in scientific/life-sciences field such as Masters, Pharm.
D, or Ph.
D/EdD degree preferredMinimum of 10 years of experience in research with at least 6 years of drug development experience are required.
Alternative drug development experience will be considered.
Prior Oncology Drug Development experience requiredGlobal oncology trial experience and Health Authority experience are highly preferredExcellent written and oral communication skillsStrong analytical and strategic abilityAbility to work independently and to multi-task large projects or compounds, ability to change pace and tasks as needed, and to work in a fast-paced environmentKnowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelinesAbility to manage direct reports a plusAbility to lead and/or be a proven leader in a line function responsibility, as well as having an ability to influence in a matrix global environmentHave proven ability to drive decisions and manage in difficult business situationsAbility to accommodate up to 20% travel or as business dictates
Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your PrivacyLearn more at Recommended Skills Advertising Analytical Business Process Improvement Clinical Research Clinical Works Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
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