Senior/Executive Director, Clinical Research Scientist jobs in United States
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Incyte · 5 hours ago

Senior/Executive Director, Clinical Research Scientist

Incyte is a biopharmaceutical company focused on developing novel medicines for oncology and inflammation. The Senior/Executive Director, Clinical Research Scientist will provide clinical research support for assigned programs, collaborating with physicians and study teams to design protocols and manage clinical data.

BiotechnologyHealth CareMedicalMedical DevicePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Design and author protocols for clinical studies
Responsible 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 committees
Lead or co-lead the ICF risk language across a compound to ensure a consistent approach
Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
Maintain alignment with the asset Global Lead, Operational Asset Lead, and Global Product Strategy Lead
Lead, 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 submissions
Manage relevant issue escalation to resolution, as items arise on Clinical Development Programs
Coordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of content
Attend 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 strategy
Clinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compounds
Contribute or lead process improvement initiatives
Provide mentoring, leadership, guidance, and clinical science expertise to Incyte personnel to enable proper decision-making
Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest
Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed
Liaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicable
Consult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgets

Qualification

Oncology Drug DevelopmentClinical Research ProtocolsFDA RegulationsGlobal Oncology TrialsAnalytical SkillsMulti-taskingClinical Science ExpertiseLeadershipCommunication SkillsTeam Management

Required

Degree in scientific/life-sciences field such as Master's, Pharm.D, or Ph.D/EdD degree preferred or equivalent experience
Minimum 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 required
Excellent written and verbal communication skills
Strong analytical and strategic ability
Ability to work independently and to multi-task large projects or compounds, ability to change pace and tasks as needed, and to work in a dynamic environment
Knowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelines
Ability 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 environment
Have proven ability to drive decisions and manage in challenging business situations
Ability to accommodate up to 20% travel or as business dictates

Preferred

Global oncology trial experience and Health Authority experience are highly preferred
Experience in managing team members is a plus

Company

Incyte is a drug discovery and development company which hopes to build a proprietary product pipeline of novel small molecule drugs.

H1B Sponsorship

Incyte has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (34)
2023 (32)
2022 (39)
2021 (36)
2020 (24)

Funding

Current Stage
Public Company
Total Funding
unknown
1996-01-16IPO

Leadership Team

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Bill Meury
President & CEO
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Jim Lee
Group Vice President, Head Inflammation and AutoImmunity Group
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Company data provided by crunchbase