Strategist, Operational Strategy / Stratège de la stratégie opérationnelle (Canada)

Reporting to the Sr. Director, Operational Strategy, the Strategist, Operational Strategy is responsible, in concert with the assigned Project Director, for defining the operational strategy (countries/sites/timelines/key project success factors, outsourcing vendor needs, risk identification, and mitigation strategies, etc.), preparation and review of commercial proposals for new studies, as well as for preparing the operational strategy content for presentations in bid defense meetings. This involves interacting with all key internal and external stakeholders to define requirements and demonstrate knowledge of the indication landscape.

The Strategist, Operational Strategy will collaborate with the Sr. Director, Operational Strategy to identify the requirements to support the definition of the operational strategy.

More specifically, the Strategist, Operational Strategy must:

• Responsible, in concert with the assigned Project Director and key collaborators, to define the operational strategy (i.e. key operational success factors, gaps from both vendors and internal factors, risk identification and mitigation, project timeline, target countries, number of sites, outsourcing vendor needs, etc.) in proposals sent to prospective clients for new business opportunities
• Review and understand the RFP and related synopsis and documents received by clients to identify project requirements
• Research and understand information on past trial performance metrics by country / site, competing landscape, clinical development, patient path, regulatory strategy, etc to support the definition of the operational strategy for each engagement
• Engage in discussions with external KOLs and expert investigators on the field as needed, as well as with clients to gather all information required to operationalize the prospective project most efficiently and under required scope
• Engage with the Innovaderm CEO, CMO, Medical and Scientific team, and key Operational Leaders to understand the significant components of the protocol design, impact on enrollment, as well as the major challenges to study success
• Request Site Selection team to collect results of pre-feasibility to adjust operational strategy as needed. Reviews pre-feasibility questionnaires and analyzes results
• Confirms with Vendor Management Innovaderm’s recommendations for the set of vendors that will be proposed to the client for the planned trial.
• Recommends to relevant internal decision makers (CEO, CMO, COO, BE, CBO) the defined operational strategy
• Defines final operational strategy to Proposal & Contract Manager to generate the budget and proposal and act as knowledgeable resource internally for operational teams, vendor management, etc
• Define resourcing needs to Project Delivery for various new projects awarded, business proposals and BID defense meetings
• Creates content and reviews proposals to ensure it is in line with the defined strategy prior to sending to the client and ensure appropriate reviewers based on expertise review the final proposal.
• Responsible in guiding the assigned Project Director, Project Manager and other key collaborators, for developing, organizing, and presenting the content for presentations in BID defense meetings
• Maintains knowledge and high familiarity with tools that inform operational strategy such as Power BI or external tools such as GlobalData, ClinicalTrials.gov, Pubmed, EU Clinical Trials Register, and clinical trial competitive intelligence
• Upon award, attend BD hand over meeting and provide background and rationale for operational strategy, client expectations as well as share with the project team an initial risk assessment
• Acts as a resource to the project team during the conduct of the clinical trial, to help them make informed decisions to address operational study challenges and need for revised project strategies.

Education

• B.Sc. in a field relevant to clinical research and/or equivalent experience

Experience

• Experience in dermatology is a must;
• Minimum of 5 years of combined experience in clinical operations and/or project management in the biotechnology, pharmaceutical, or CRO industry, including a minimum of 2 years in a leadership capacity in project management/clinical research; 
• Experience in a CRO is a requirement

Skills and knowledge

• Excellent understanding of all services offered by a CRO in a clinical project (medical and scientific writing, clinical trial management, clinical monitoring, data management, statistics, regulatory affairs, medical monitoring, and pharmacovigilance) as well as overall risk management process;
• Profound knowledge of ICH-GCP standards and applicable regulatory requirements;
• Excellent oral and written English skills. Knowledge of French is an asset;
• Ability to work in a fast-paced evolving environment and establish good relationships with colleagues and sponsors;
• Quick learner, good adaptability and priority management;
• Strong organizational, communication, time management and multi-tasking skills;
• Excellent leadership, judgment, soft and problem-solving skills