Clinical Scientist

Zymeworks Inc.•Vancouver, BC

17d

About The Position

With appropriate supervision, manages the design and implementation of study protocols for a clinical development program, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues. Oversees project-related education of investigators, study site personnel, and study staff. Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the asset. Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area Support database design and contribute to case report form (CRF) completion guidelines Educate internal study team members, clinical sites on protocol requirements. Collaborate with the Clinical Trial Manager (CTM) to support study start-up, conduct, and close-out activities Provide scientific input into vendor scope of work (SOW), contracts, and study charters Partner with vendors to ensure delivery of high-quality data and scientific integrity of services Perform ongoing clinical data review, including protocol deviations, to ensure data quality, accuracy, and scientific validity Identify data trends, summarize findings, and escalate clinical or medical concerns to the Medical Monitor as appropriate Review MedDRA and WHODRUG coding to ensure consistency and accuracy Represent Clinical Development on cross-functional study teams and at internal or external meetings May be asked to contribute to regulatory responses and discussions. Contribute to continuous improvement of clinical processes and study execution Perform other duties as assigned

Requirements

Advanced degree in life sciences or a clinical field (e.g., RN, NP/ARNP, PharmD, Physician Assistant, PhD, MD, or equivalent) required
Minimum of 2+ years of relevant experience in the biopharmaceutical industry or a comparable clinical research setting preferred
Strong ability to interpret and analyze clinical data with a focus on scientific rigor
Solid understanding of clinical development processes, GCP, and regulatory requirements
Proficiency in medical terminology
Demonstrated ability to assimilate complex scientific information quickly
Excellent analytical, problem-solving, and critical thinking skills
Strong written and verbal communication skills, with the ability to clearly convey scientific information
Highly collaborative with the ability to work effectively in cross-functional teams
Strong organizational skills, attention to detail, and commitment to data accuracy
Ability to manage multiple priorities in a fast-paced environment and adapt to changing needs
Proficiency with Microsoft Office Suite

Nice To Haves

Oncology experience strongly preferred

Responsibilities

Manages the design and implementation of study protocols for a clinical development program
Oversees project-related education of investigators, study site personnel, and study staff.
Has responsibility for oversight of clinical studies, monitoring overall study integrity
Review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the asset.
Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area
Support database design and contribute to case report form (CRF) completion guidelines
Educate internal study team members, clinical sites on protocol requirements.
Collaborate with the Clinical Trial Manager (CTM) to support study start-up, conduct, and close-out activities
Provide scientific input into vendor scope of work (SOW), contracts, and study charters
Partner with vendors to ensure delivery of high-quality data and scientific integrity of services
Perform ongoing clinical data review, including protocol deviations, to ensure data quality, accuracy, and scientific validity
Identify data trends, summarize findings, and escalate clinical or medical concerns to the Medical Monitor as appropriate
Review MedDRA and WHODRUG coding to ensure consistency and accuracy
Represent Clinical Development on cross-functional study teams and at internal or external meetings
May be asked to contribute to regulatory responses and discussions.
Contribute to continuous improvement of clinical processes and study execution
Perform other duties as assigned