Medicago inc. Senior director – clinicals studies Full Time in Quebec City, QC

Medicago inc.

Branch Quebec City QC CA

Senior director – clinicals studies
Quebec City, QC

Minimum of 7 years of experience in clinical operations in biotech, pharmaceutical or medical device, CMO or CRO;…

Reporting to the Executive Vice-President Scientific & Medical Affairs, the Senior Director Clinical Studies is responsible for the conduct of clinical studies in compliance with GCPs and according to corporate objectives and SOPs.

Principal functions and responsibilities:
Responsible for the conduct of Phase I-III clinical studies in collaboration with selected partners;

Plan the evaluation and selection of clinical sites;

Participate in the development of clinical protocols;

Participate in the writing of documents required for the conduct of clinical trials such as: Investigator’s brochure (IB), Study Laboratory Manual etc.;

Revise statistical analysis plans and clinical study reports;

Coordinate activities between the clinical department and the other departments;

Participate in the writing of regulatory dossier;

Ensure that clinical studies are conducted in compliance with Good Clinical Practices (GCP), internal Standard Operating Procedures (SOP) and other regulations;

Ensures adherence to governmental regulations;

Collaborate with the clinical team to ensure proper management of contracts and regulatory documents;

Play a role in the departmental growth and recommend/prepare budgets according to corporate objectives;

Ensure compliance with budgets, schedules and performance requirements;

Contribute to the compilation, analysis and reporting of study results;

Coach, mentor and develop roles and responsibilities of managers under his/her supervision;

Any other duties as required.

M.Sc. degree in life science;

Minimum of 7 years of experience in clinical operations in biotech, pharmaceutical or medical device, CMO or CRO;

Extensive knowledge of FDA, ICH and GCPs regulations;

Ability to lead, influence, create and work within a cross-functional team environment;

Strong personal presence with the ability to command respect through exercise of sound business judgment and clear decision-making;

Excellent communication skills with the ability to efficiently and productively communicate both orally and in writing;

Experience in budget management and contract negotiation;

Strong ability to manage multiple tasks with priorities in a fast-paced matrix environment;

Interpersonal skills and ability to work both in a team and autonomously;

Bilingual, French and English (both oral and written);

Good knowledge of Office Suite and applications, software related to statistics and clinical activities ;

Available to travel for business purposes.

or proceed with Standard Application Form.

Employment Type: Full Time
Location: Québec City, QC, CA
Posted on: 2017-10-30
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