Therapeutic Strategy Lead - Level Dependent on Experience

Therapeutic Strategy Lead

This person will lead the development of delivery strategies for clinical trials at CTI, leveraging broader organizational and industry knowledge and relationships to support integrated, multi-service line customer solutions. Lead the therapeutic and operational input into upstream design efforts for early engagement and support sales efforts for competitive bids. Support growth efforts in the commercial organization through client meetings, conference attendance, COE leadership, and creation of externally facing content. Identify opportunities to enhance CTI delivery of services to enhance the sponsor experience, driving increased quality and efficiency. Considers patient-centric and innovative approaches that improve outcomes for patients, caregivers, and sites.
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)
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