The Director - Contract - Wilmington, DE
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.
Primary Responsibilities:
The successful candidate will collaborate with physicians, clinical scientists, and cross-functional teams to support oncology clinical development, focusing on protocol development and study start-up activities.
Skills & 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.
The Director's responsibilities will be:
- 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
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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