Job Description

Job Description

Job Description

About the position:

The Associate Director/Director of Clinical Research, in collaboration with the Medical Monitor, is responsible for the design, conduct, analysis, and reporting of clinical trials. This individual will assume a lead role in trial planning and execution, working with a multi-disciplinary team to ensure clinical, scientific, and regulatory issues are appropriately addressed throughout the clinical trial. This individual will act as the clinical development lead for 1-2 clinical trials, inclusive of study start-up, management, and close-out activities. This person will work closely with the cross-functional team to ensure that clinical programs are executed and delivered in accordance with the overall clinical development strategy.

• Author relevant study documents including clinical protocols/amendments, informed consent forms, and contribute to relevant study documents including eCRF design, clinical study reports, annual updates, investigator brochures, study reference manuals, etc. Co-ordinate the preparation and publication of reports, ensuring that they meet regulatory and contractual requirements. Address questions from IRB/EC for clinical issues.
• In collaboration with the Medical Monitor, prepare content, draft minutes and coordinate safety monitoring committee meetings. Monitor trial progress to ensure compliance with and adherence to the project plan and proactively identify, evaluate, and rectify problems.
• Participate in the selection of investigator sites and vendors for clinical trials. Work closely with the clinical study lead to maintain frequent and meaningful contact with sites and CROs, providing oversight and guidance as needed.
• Perform instream clinical data review in collaboration with data manager and medical monitor and contribute to safety and efficacy signal interpretation, identify trends in protocol deviations, and ensure GCP compliance.
• Work closely with the medical monitor, translational medicine and biostats to perform analysis of pharmacokinetic and pharmacodynamic studies.
• Author presentations of clinical data for conferences, advisory boards, and roundtables with investigators or external KOLs. Author clinical study manuscripts, abstracts, and presentations.
• Provide or facilitate training of study team members and investigator site personnel on protocol-specific topics.
• Create and iteratively update clinical development plans to be aligned with a Target Product Profile. Follow changes in the clinical landscape and competitors for specific indications and/or molecular targets of interest.

Qualifications/requirements

• BS/MS in science or healthcare. PhD, PharmD, or nursing background preferable.
• Minimum of 8 years of clinical research experience, including at least 3 years at a pharmaceutical or biotechnology organization.
• Oncology experience required; immuno-oncology experience is preferred.
• Knowledge of clinical drug development, with experience in Phases I-III. IND and BLA/NDA experience preferable.
• Thorough understanding of ICH GCP and FDA guidelines.
• Ability to author key clinical documents and or relevant clinical sections, including protocols, Investigator Brochures, Data Safety Update Reports, Clinical Study Reports, clinical safety narratives, Informed Consent Forms, conference abstracts, etc.
• Experience performing clinical data review, with solid understanding of the data collection and compilation processes.
• Strong interpersonal skills with demonstrated ability to effectively work with internal cross- functional as well as external groups.
• Well-developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
• Candidate must be sharp, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.
• Strong computer skills with demonstrated experience in working with the MS Office platform.

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