Duchesnay Inc., located in Blainville, Quebec, in the Lower Laurentians, is a specialty pharmaceutical company with a long-standing commitment to women’s health. Until recently, the company focused on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding.
Today, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives.
Duchesnay offers its employees state-of-the-art facilities and a stimulating and safe work environment.
Role and Responsibilities
- Lead operational aspects of the assigned clinical trial (s) to ensure that milestones and key targets are determined and met
- Actively manage and oversee CROs, vendors, contractors and collaborators involved in the operations of the clinical trial program(s)
- Ensure clinical trial compliance with applicable regulations, guidelines (ICH and GCP), and corporate policies for trial activities
- Ensure the development and maintenance of project-specific tracking systems to enable proper trial management and monitoring activities, as required
- Manage timelines, resource projections and clinical trial budgets for the clinical trial program(s)
- Identify obstacles to the successful completion of the clinical trial and develop contingency plans to mitigate risk
- Integrate all clinical trial related activities and timelines, as well as provide status reports and updates on a routine basis
- Facilitate and encourage the development and recognition of all our businesses in Canada and the US: Duchesnay Inc. and Duchesnay USA, Medunik Canada & USA products
- Provide scientific expertise regarding products in the therapeutic areas concerned, namely to the Sales, Business Development, Market Access and Regulatory Affairs teams (e.g. review documents required for regulatory submissions, validate medical and scientific content of promotional materials, conduct clinical evaluations of potential products, etc.)
- Act as resource person for MSL training
- Review the scientific literature and synthesize findings for internal teams (e.g. produce summaries, clinical presentations or histories of the natural evolution of a disease)
- Contribute to the creation of reimbursement files (explanation/comparison of therapy or product cost, review “Common Drug Review” evaluator/reviewer reports)
- Develop and implement publication plans, in collaboration with clinical research partners and the communication and commercial teams, to optimize awarness of medical conditions and product attributes
- Participate in medical education for healthcare professionals by presenting at research meetings, advisory boards or other forums to promote knowledge of the product or the illness
- Coordinate and develop medical education programs and provide training to the teams responsible for product promotion
- Maintain scientific expertise by participating in conferences and scientific workshops and by reviewing scientific publications
- Review the scientific content of Med-Info response to requests beyond information contained in product monographs, full prescribing information, etc.
- Collect, analyze and report scientific information that could influence product development plans
- Identify, establish and maintain collaborative relationships with key opinion leaders (KOLs) and strategic organizations for the development of our products
- Collaborate with targeted institutions and relevant KOLs to implement research or training activities
- Develop scientific material for distribution to KOLs
- Participate in the preparation of R&D tax files and annual reports for Revenue Canada and Revenue Quebec
- Respect the policies and procedures established by Duchesnay
- Perform any other tasks related to the position
- Minimum of five years’ experience involving Phase II or III multi-centre clinical trials both directly and with assistance from a CRO
- Solid working knowledge of guidelines and regulations: includes ICH, FDA and Health Canada for clinical trials, quality assurance and safety
- Proven experience leading project teams through the start-up, trial conduct, data management, close-out and reporting of clinical trials
- Demonstrated successful project management skills, adhering to project timelines and setting milestones for a clinical trials
- Ability to synthesize and analyze scientific information in a marketing, regulatory and commercial context
- Demonstrated ability to develop and promote peer-to-peer relationships with key opinion leaders and decision makers
- Team player
- Strategic thinker with strong analytical and decision-making skills
- Strong leadership skills and highly autonomous
- Solid interpersonal, communication and presentation skills
- Ability to build cooperative and trusting relationships that promote a healthy work environment
- Relevant graduate degree (PhD, MD or Pharm D)
- Minimum of 5 years of experience involving multi-centre clinical trials in the pharmaceutical, biotechnology or CRO industry, with an interest to transition towards a medical role in the next year or two
- Minimum of 2 to 3 years of experience in a similar position in the pharmaceutical and/or biotechnology industry is an asset
- Knowledge of women’s health is an asset; however, the ability to acquire expertise in other therapeutic (or product) areas according to changing business priorities is essential
- Experience in coordinating multidisciplinary teams, projects and initiatives
- Experience in setting up and/or managing clinical/scientific trials
- Strong verbal and written communication skills in French and English (medical writing experience is an asset)
- Excellent knowledge of Microsoft Office applications
- Availability to travel approximately 30% of the time
We offer a competitive salary and a full range of fringe benefits. This is a permanent position and available immediatly.
If you are interested and have the required qualifications, please submit your resume.
- By e-mail: firstname.lastname@example.org
We thank all applicants for their interest; however, only selected candidates will be contacted.
Duchesnay Inc. is an equal opportunity employer.