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Turn scientific insight into life-changing oncology therapies through clinical leadership. Proclinical is seeking a Director, Clinical Research Scientist with expertise in oncology to join a dynamic team in the US. This position emphasizes leadership in clinical research and offers the opportunity to contribute to groundbreaking work in immuno-oncology.
Job Responsibility
Collaborate with physicians, clinical scientists, and cross-functional teams to support oncology clinical development, focusing on protocol development and study start-up activities.
Development of protocols for clinical studies.
Preparation of clinical development plans.
Drafting of clinical scientific documents such as IND, IND amendments, Investigator's Brochures, Annual Reports and other FDA submissions.
Monitor, perform data review, and summarize safety and efficacy data in ongoing studies.
Assist with study design for exploratory development.
Lead the clinical matrix teams for assigned compounds.
Represent exploratory development on project teams.
Develop relationships with appropriate consultants.
Write abstracts and present data at scientific meetings, both internally and externally.
Serve as liaison to project teams, CROs and others
Requirements
Degree in a scientific/life sciences field
Pharm.D. or Ph.D. preferred.
Minimum of 8 years of experience in oncology research or related field.
Demonstrated experience leading clinical development programs in oncology (preferably late-stage).
Experience with global regulatory interactions and submissions (FDA, EMA, or other agencies).
Strong understanding of oncology clinical endpoints, trial design, and statistical considerations.
Proven ability to work effectively in a cross-functional matrix environment and influence without direct authority.
Track record of scientific publications and/or conference presentations.
Excellent written and oral communication skills.
Strong analytical and scientific writing skills.
Ability to manage multiple priorities in a fast-paced environment.
Minimal travel (?15%) may be required with prior approval.