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Director, Therapeutic Strategy Lead - Level Dependent on Experience

raleigh, nc • Posted 1 weeks ago
Remote Full Time Management & Operations

What You’ll Do:

  • Therapeutic Strategy Leadership
    • Serve as a champion for staying abreast of trends and development of treatments in assigned therapeutic areas (approaches to care, impact of regulations, patient centricity, etc.)
    • Utilize therapeutic knowledge and experience to lead and support early engagement, business development growth generation, and therapeutically aligned clinical trial oversight and execution activities
    • Collaborate with all CTI business units for effective end-to-end therapeutically aligned customer solutions
    • Involved in the full RFP response process including leading the development of the delivery strategy, contributing text or figures/tables to the deliverable(s), reviewing the CTI budget, engaging with CTI stakeholders across functions, supporting/developing content for bid defense meetings
  • Business Development – Growth Generation
    • Provide therapeutic insights and operational strategy in targeted new customer opportunities, supporting all sales efforts in aligned indications
    • Support all multi-service line sales strategies for key customer base in given indications
    • Help define targeted customers and sales approaches for new and established relationships
    • Attend key conferences as needed to support client engagement activities and new business lead generation
    • For competitive bids and pre-award activities, provide input and guidance during requests for information (RFIs), requests for proposals (RFPs), and bid defense process, to help drive strategy and increase CTI win rate
    • Work directly with Clin Ops and BD to provide therapeutic insights in the development of proposal strategies and scenarios to help secure new and repeat business
    • Liaise between Clin Ops, BD, RSA, Medical Affairs, DCT systems and Data Assets partners, and BD Ops to develop study strategies, budgets, and customer messaging
    • Review RFIs, budgets, and proposals, ensuring market competitive study design and pricing
    • Support team in prep and/or attend Bid Defense Meetings as required. Travel up to 30% based on work volume. Periodic international travel may be required.
    • Support the Sales team in the development of strategic plans and sales strategies within specified accounts
    • Attend meetings/teleconferences (TCs) with (potential) clients as requested
    • Establish and maintain regular contact and excellent rapport with future and current clients; develop account strategies and implementation plans, and expand through accounts
    • Collect and synchronize operational inputs for proposal deliverables within the defined process timeline
    • Works directly with site feasibility staff to determine site/country mix strategy and associated timelines for a given study or opportunity
  • Therapeutically Aligned Clinical Oversight and Execution
    • Development and maintenance of tools, templates, training, systems, and vendors that foster efficiencies and effectiveness in running these types of trials
    • Collaborate with Clin Ops team to provide details about challenges/risks and mitigation strategies
    • Provide input regarding any key operational innovations (Decentralized Clinical Trials (DCT), remote-based monitoring (RBM), etc.) for protocol development and operational execution
    • Provide clear transition of strategy history, methodology, study design, etc to Clinical Project Manager (CPM) / operational owners
    • Support early engagement, protocol amendments, or study redesign as needed, in collaboration with RSA, Clin Ops, Feasibility, Medical Affairs, and customer

What You’ll Bring:

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution
  • Minimum of five (5) years of clinical research experience in project management; at least three (3) years in a CRO operations environment; 5 years of Therapeutic Strategy Lead or similar experience.
  • Experience in designing and managing clinical trials in therapeutic areas of expertise
  • Experience in big data analytics as it relates to study/program design and enrollment modeling (including site and country distribution/scenarios)

Why CTI?

  • We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
  • We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
  • We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade

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