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Senior Director, Clinical Research Scientist
Senior Director, Clinical Research Scientist
Senior Director, Clinical Research Scientist
Posted 9 days ago
- London, Greater London
- Any
- External
Senior Director, Clinical Research Scientist - Oncology
Global Pharma company
This position is responsible for collaborating with physicians in Clinical Development to deliver clinical research support for assigned programs, based on phase or therapeutic area.
Essential Functions of the Job
1. Develop protocols for clinical studies.
2. Contribute to the development of program strategy for assigned compounds/programs, including participating in the preparation of clinical development plans.
3. Draft and review clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, and other Health Authority submissions.
4. Provide clinical input into eCRF design, SAP, and TLFs.
5. 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.
6. Represent clinical development on project teams.
7. Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
8. Act as the clinical lead for study abstracts, posters, oral presentations, and manuscripts for assigned studies.
9. Serve as a liaison to project teams, CROs, Clinical sub-teams, and others.
10. Maintain updated knowledge of the competitive landscape in regard to assets with similar mechanisms of action (MOA) and/or evolving standards of care for indications of interest.
Qualifications:
Degree in a scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
A minimum of 8 years of experience in research, with at least 5 years of drug development experience required. Alternative drug development experience will be considered.
Prior experience in IAI and/or Dermatology Drug Development is preferred.
Ability to work independently, multitask, 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.tten and oral communication skills.
Strong analytical ability.
Ability to accommodate up to 20% travel or as business dictates.
Global Pharma company
This position is responsible for collaborating with physicians in Clinical Development to deliver clinical research support for assigned programs, based on phase or therapeutic area.
Essential Functions of the Job
1. Develop protocols for clinical studies.
2. Contribute to the development of program strategy for assigned compounds/programs, including participating in the preparation of clinical development plans.
3. Draft and review clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, and other Health Authority submissions.
4. Provide clinical input into eCRF design, SAP, and TLFs.
5. 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.
6. Represent clinical development on project teams.
7. Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
8. Act as the clinical lead for study abstracts, posters, oral presentations, and manuscripts for assigned studies.
9. Serve as a liaison to project teams, CROs, Clinical sub-teams, and others.
10. Maintain updated knowledge of the competitive landscape in regard to assets with similar mechanisms of action (MOA) and/or evolving standards of care for indications of interest.
Qualifications:
Degree in a scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
A minimum of 8 years of experience in research, with at least 5 years of drug development experience required. Alternative drug development experience will be considered.
Prior experience in IAI and/or Dermatology Drug Development is preferred.
Ability to work independently, multitask, 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.tten and oral communication skills.
Strong analytical ability.
Ability to accommodate up to 20% travel or as business dictates.