Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
Has overall responsibility for monitoring the integrity of clinical studies, and review, interpretation, and discussion of accumulating data pertaining to safety and efficacy of the drug.
Oversees the work of medical staffs, and of clinical scientists working on the same or related programs.
Collaboratively prepares and reviews scientific content of study protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
Hands-on involvement in the design and writing of clinical study protocols from first-in-human phase I to phase II-III pivotal studies that will support regulatory approvals.
Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, pharmacovigilance standards, local regulations and laws.
Leading regular teleconferences with academic clinical investigators.
Works closely with Pharmacovigilance from CRO on development of Risk Management Plans. Act as Medical Monitor for sponsored clinical trials and provide adverse event safety monitoring and reporting. Supports adverse event reporting and patient safety.
Medical monitor for clinical trials, including evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase I, and assessing early pharmacodynamics.
Provides medical review, assessment and interpretation of clinical and safety data to ensure that the data are correct and presents with the appropriate medical interpretation.
With Principal Investigators (PIs) and CRO team, assesses patient eligibility, discusses safety concerns, provides rational and feasible advice, and manages ongoing protocol issues.
If necessary, makes recommendations for those studies which need to be re-evaluated, including the decision to halt/terminate a study.
Works closely with R&D team, regulatory affairs, and Clinical Operations to assure timely filing of all clinical applications.
Collaboratively prepares manuscripts and presentations for external meetings, and clinical sections of regulatory documents (IND and NDA sections).
M.D. or PHD degree with experience in oncology.
At least 10 years of clinical trial experience in the biotechnology or pharmaceutical industry.
Strong leadership skills and proven biopharmaceutical industry experience including planning, designing and executing clinical trials in phase I-III. Extensive experience is highly desired in high-complexity first-in-human studies.
Knowledge of global regulatory and compliance requirements and experience in development of clinical strategy and the design of study protocols.
Strong scientific, medical and analytical abilities with innovative, solution-oriented style.
Strong understanding of the drug development process from IND to NDA, including novel clinical study designs, patient selection, and pharmacovigilance.
Demonstrates extensive successful experience leading the clinical aspects of interactions with Regulatory Authorities, such as FDA.
Strong interpersonal, communication and collaboration skills to connect with internal and external CROs.