Principal Clinical Research Scientist/Manager
Cangene Corporation is seeking a Principle Clinical Research Scientist Manager who has a passion for excellence and a desire to maximize their potential in our Clinical Research Department.
As a key member of the Department’s leadership team, the Principal Clinical Research Scientist Manager will lead and mentor a talented group of Clinical Research Scientists and Biostatisticians as they work towards accomplishing the objectives for Cangene’s clinical research programs.
What sets us apart?
Our Clinical Research Department is comprised of a strong team of Clinical Research Scientists, Biostatisticians, Statistical Programmers, a Data Management Group and a Clinical Operations team. We support the Clinical Trial phase of drug development as well as post licensure requirements for our products. We work as a team to achieve corporate goals and this often has us collaborating with members of our Toxicology, Preclinical, Pharmacovigilance, Regulatory Affairs and even our Manufacturing groups. It is this collaboration between departments that truly sets us apart. We learn from each other, celebrate our big wins together and are proud of each other’s accomplishments.
- Responsible for clinical development plans, trial design, protocol development, data review, analysis and interpretation
- Responsible for clinical research studies from trial design to final study report
- Provide direction to the clinical science and biostatistics team responsible for clinical drug development programs
- Review and provide guidance on drug development documents and strategies, study designs and various report documents
- Lead efforts to author clinical sections of regulatory documents including IND and BLA/NDS, investigator’s brochure, developmental safety update reports, clinical overview and summaries
- Ensure trials are designed to meet desired clinical endpoints and with appropriate methods and measurements
- Review, maintain and develop SOP’s
- Responsible for department compliance with regulations, guidelines, GCP and procedures
- Track progress of clinical development programs and addresses problems as necessary
- Ensure appropriate, comprehensive and professional scientific/medical communications both internally and externally
- Develop, prioritize and meet measurable short and long term objectives for clinical research programs
- Liaise with other internal groups including Research & Development, Regulatory Affairs and corporate project management groups to ensure common goals are met
- Oversee financial and human resource management including work assignments, forecasting, planning and tracking
- Build, coach and mentor clinical science and biostatistics team
- Manages identification and relationships with clinical consultants
Our ideal candidate will meet or exceed these qualifications:
- Achieved an advanced degree in Life Sciences or Medicine (PhD, PharmD or MD preferred)
- Encompasses extensive knowledge and understanding of Health Canada, FDA and ICH regulatory requirements and procedures applicable to Clinical Research and Product
- A minimum of five years experience in the pharmaceutical industry with proven experience leading high quality, successful teams.
- Experience in biostatistics and data management is an asset.
- Demonstrated ability to set and communicate goals, and to drive efforts, overcome obstacles and achieves results within budget and timeline specifications.
- Experience presenting in public or regulatory settings.
- Excellent organizational, analytical, leadership, problem solving and interaction skills.
- Ability to coordinate a variety of tasks in a highly diverse and fast paced, team environment.
- Excellent written/verbal communication and interpersonal skills as well as excellent computer skills required.
As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. This position will be located in Winnipeg, Manitoba Canada. Relocation assistance is available. Please email your resume and cover letter to hr @cangene.com. Resumes will be reviewed as received.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and...