Clinical Development Lead

DURATION – Permanent

SALARY- HIGHLY COMPETITIVE

LOCATION- England, hybrid

SUMMARY:

I'm currently supporting an exciting and innovative biotech who are leaders in working with antibodies and have a technology toolbox that is constantly expanding. They are now looking for a talented individual to join their late stage Clinical Development team. This individual will be will supporting the Clinical Development physicians and clinical study team to design and scientifically conduct clinical trials. With a growing team of 300 employees globally, they are looking forward to welcoming this clinical professional on a hybrid basis.

YOUR RESPONSIBILITIES:

• Identifies study and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD.
• Performs review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
• Writes content for program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
• Develops presentations and communicates study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
• Maintains current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Serves as clinical science representative on cross-function teams as assigned.

YOUR BACKGROUND:

• Clinical or science degree (e.g. RN, NP, MSN, PharmD, PhD, MD) in a clinical discipline
• Extensive experience in hematology/oncology clinical research experience in planning, executing, reporting and publishing studies within the pharmaceutical industry.
• Demonstrated ability to review and summarize oncology study data, including experience in preparing and presenting data.
• Thorough understanding of the oncology drug development process from pre-IND through registration and post-registration required.
• Broad understanding of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences ideal
• Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.