Associate Director
Vor 3 Tagen
Incyte is a pioneering biotech with a research driven nature and passion for innovation, with a mindset that every challenge we face is a chance for a breakthrough opportunity to find meaningful solutions for patients.
Our talented team of more than 600 scientists is constantly strategizing to identify new molecules, decipher new pathways and develop impactful medicines for people living with cancer and immune-mediated diseases.
Join us as **Associate Director/Director, Clinical Research Scientist **in our talented and dynamic Early Clinical development team to contribute to the development of Hem/Onc programs by being responsible of clinical research activities for assigned clinical studies in close collaboration with a physicians.
**Duties and Responsibilities**
- Development of protocols for clinical studies.
- Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans.
- Drafting of clinical scientific documents such as IND, IND amendments, Clinical Study Reports, Investigator Brochures, Annual Reports and other health authorities submissions.
- Responsible for providing clinical input into eCRF design, SAP, and TLFs.
- Monitor, review and summarize clinical safety and efficacy data in ongoing studies.
- 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.
- Will lead the clinical matrix teams for assigned studies, represent clinical development on project teams and serve as liaison to project teams, CRO's and others.
- Provide clinical updates on assigned studies 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.
- Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed.
- Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
- Contribute to writing and review of study abstracts, posters, oral presentations and manuscripts for assigned studies.
- Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.
**Requirements**:
- Degree in scientific/life-sciences field, PharmD, or PhD preferred.
- Minimum of 1 - 3 years of experience in research with at least 3+ years of clinical research/drug development experience are required for Associate Director/Director level.
- Experience in Oncology field is required.
- Ability to multi-task and work in a fast-paced environment.
- Excellent written and oral communication skills.
- Strong analytical ability.
- Ability 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.
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You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).
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