Strategist, Operational Strategy


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.) in the preparation and review of commercial proposals for new studies, as well as for preparing the operational strategy content for presentations in bid defense meetings.

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

 

RESPONSIBILITIES

 

More specifically, the Strategist, Operational Strategy:

  • Is 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.
  • Collaborates with Sr. Director, Operational Strategy to identify the research to support the definition of the operational strategy for each engagement.
  • Liaises with the relevant internal decision makers (CEO, CMO, COO, BE, CBO) to define the operational strategy.
  • Communicates final decisions on operational strategy to Proposal & Contract Manager for the budget and proposal development.
  • Draft/Review operation and strategy key sections of the proposals prior to sending to the client and ensure appropriate reviewers based on expertise review the final proposal.
  • Responsible, in concert with the assigned Project Director and other key collaborators, for developing, organizing, and presenting the operational content for presentations in bid defense meetings.
  • Liaises with Project Delivery to review lessons learned from similar projects conducted by Innovaderm.
  • Maintains knowledge and high familiarity with tools that inform operational strategy such as Power BI or external tools such as GlobalData, ClinicalTrials.gov, EU Clinical Trials Register, and clinical trial competitive intelligence.
  • Communicates closely with Business Development to thoroughly understand the intended use of the study data, along with the business goals and sensitivities of the client.
  • Partners with the Innovaderm Medical team, and external Key Opinion Leaders (KOLs) to understand the significant components of the protocol design, as well as the major challenges to study success.
  • Liaises with the Innovaderm CRU in order to understand the trial logistic issues from the site perspective, as well as get their input on the ‘attractiveness’ or challenges of the study to prospective investigators as well as prospective patients.
  • Works closely with Regulatory Affairs to understand the quickest and simplest pathway to study activation and conduct in the different countries considered.
  • Collaborates with potential CRO partners for regions where Innovaderm does not have the expertise/capacity to conduct trials directly.
  • Interact with Site Selection team to determine potential needs and results of pre-feasibility to adjust operational strategy as needed. Reviews pre-feasibility questionnaires and analyzes results.
  • Interacts with Vendor Management to confirm recommendations for the set of vendors that will be proposed to the client for the planned trial.
  • Communicates closely with Innovaderm’s local operational leaders (i.e. North America, Europe) to ensure that the regions being suggested are capable of handling the workload.
  • Forecasts and communicates with Project Delivery regarding the needs for various new business proposals and bid defense meetings.
  • At the BD Handover meeting, provide background and rationale for how the operational strategy was developed and agreed with the client, as well as share with the project team the outcome of the 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.

 

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 Innovaderm, 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
  • Permanent full-time position
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
  • Ongoing learning and development

 

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

 

Innovaderm only accepts applicants who can legally work in Canada.

All Available Positions


Position Department Location
Bilingual Clinical Research Associate II CRO - Clinical Operations Montreal or Toronto, Canada
Proposal and Contract Manager Corporate - Business Development and Marketing Canada
Line Manager, Statistical Programming CRO - Biometrics India
Specialist, Digital Marketing CRO - Project Management Canada
Specialist, Digital Marketing (US) CRO - Project Management Eastern USA
Associate Director, Patient Recruitment (Poland) CRO - Project Management Poland
Associate Director, Patient Recruitment (Spain) CRO - Project Management Spain
Associate Director, Patient Recruitment (US) CRO - Project Management North Central USA
Associate Director, Patient Recruitment CRO - Project Management Canada
Line Manager, Project Coordination CRO - Project Management Montreal, Canada
Clinical Scientist CRO - Medical Affairs India
Senior Computerized System Validation Analyst Corporate - Quality and Compliance India
Strategist, Operational Strategy Corporate - Business Development and Marketing Canada
Director, Patient Recruitment (Canada) CRO - Project Management Canada
Director, Patient Recruitment (Poland) CRO - Project Management Poland
Director, Patient Recruitment (USA) CRO - Project Management USA
Director, Patient Recruitment (Spain) CRO - Project Management Spain
Manager, Regulatory Affairs (Spain) CRO - Regulatory Affairs Spain
Proposal & Contract Manager (India) Corporate - Business Development and Marketing India
Regulatory Affairs Specialist (Spain) CRO - Regulatory Affairs Spain
Regulatory Affairs Specialist - Poland and/or Spain CRO - Regulatory Affairs Poland or Spain
Manager, Regulatory Affairs (Poland) CRO - Regulatory Affairs Poland
Human Resources Technician Coporate - Human ressources Montreal, Canada
Future opportunities General North America, Europe and India