## Strategist, Operational Strategy / Stratège de la stratégie opérationnelle (Canada)Canada (remote) · Permanent · Professional#### About The PositionReporting 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.#### Requirements**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#### Our company**The Work Environment****At Indero**, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.In this position, you will be eligible for the following perks:* Flexible work schedule* Home-based position* Ongoing learning and development opportunities**About Indero****Indero** is a CRO specialized in **dermatology and rheumatology**. Since its beginnings in 2000, our organization has built a strong reputation for delivering high-quality research and services that exceed client expectations. Based in Montreal, Indero continues to grow and expand across North America and Europe.**Indero** is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.**Indero** only accepts applicants who can legally work in Canada.#### Description de posteSous la responsabilité du directeur principal de la stratégie opérationnelle, le stratège de la stratégie opérationnelle est chargé, de concert avec le directeur de projet désigné, de définir la stratégie opérationnelle (pays/sites/calendriers/facteurs clés de réussite du projet, besoins des fournisseurs d'externalisation, identification des risques et stratégies d'atténuation, etc.), de préparer et d'examiner les propositions commerciales pour les nouvelles études, ainsi que de préparer le contenu de la stratégie opérationnelle pour les présentations lors des réunions de défense de l'offre. Cela implique d'interagir avec toutes les principales parties prenantes internes et externes pour définir les besoins et démontrer la connaissance du paysage des indications.Le stratège, stratégie opérationnelle, collaborera avec le directeur principal, stratégie opérationnelle, afin d'identifier les besoins pour soutenir la définition de la stratégie opérationnelle.Plus précisément, le stratège en stratégie opérationnelle doit :* En collaboration avec le directeur de projet désigné et les principaux collaborateurs, définir la stratégie opérationnelle (c'est-à-dire les principaux facteurs de réussite opérationnelle, les lacunes dues aux fournisseurs et aux facteurs internes, l'identification et l'atténuation des risques, le calendrier du projet, les pays cibles, le nombre de sites, les besoins des fournisseurs en matière d'externalisation, etc.* Examiner et comprendre l'appel d'offres et les synopsis et documents connexes reçus par les clients afin d'identifier#J-18808-Ljbffr
Strategist, Operational Strategy / Stratège De La Stratégie Opérationnelle (Canada)
INNOVADERM RESEARCH
, , canada, , , canada
Published 27 days ago
Report job