Qualifications
Key Responsibilities:Develop and implement the medical strategy for designated oncology programs.Draft clinical protocols for Phase 1-2 trials and contribute to essential documentation such as investigator brochures, IND/CTA submissions, and clinical study reports.Act as the Medical Monitor for clinical trials, overseeing patient eligibility, safety measures, and adherence to protocols.Analyze clinical trial data, focusing on safety, efficacy, pharmacokinetics, and pharmacodynamics, translating findings into strategic development actions.Ensure compliance with Good Clinical Practices (GCP), regulatory requirements, and company Standard Operating Procedures (SOPs).Serve as the key clinical contact for internal teams, external investigators, and regulatory bodies.Foster collaborative relationships with medical experts and investigators in the relevant therapeutic areas.Work closely with cross-functional teams including Translational Science, Clinical Operations, Regulatory Affairs, and Biostatistics.Prepare publications and present data and strategic insights to governance committees and at external conferences.
About the job
At AbCellera, we understand that the need for innovative medicines is paramount. Our mission is to consistently defy expectations by delivering groundbreaking therapies to patients who need them most. Driven by a commitment to scientific integrity and a willingness to explore the unknown, we are seeking a talented Medical Director to join our Clinical Development team, focusing on our oncology pipeline.
In this pivotal role, you will lead the medical and scientific strategy for early oncology programs, guiding them from pre-IND/CTA stages through Phase 1 and 2. Your expertise will be essential in the design and execution of clinical studies, ensuring rigorous medical monitoring, and delivering insightful interpretations of clinical trial data while adhering to the highest standards of safety and regulatory compliance.
About Abcellera
AbCellera is at the forefront of biopharmaceutical innovation, dedicated to transforming the way we discover and develop new therapies. Our team passionately strives to bring forward the next generation of medicines, driven by a culture of scientific excellence and collaboration.