Director, Therapeutic Strategy Lead - Level Dependent on Experience

CTI Clinical Trial and Consulting Services; Covington (KY); On-site; USD 90,000 - 120,000; Full time

Job summary

CTI Clinical Trial and Consulting Services in Covington, Kentucky seeks a candidate to lead delivery strategies for clinical trials. Responsibilities include providing therapeutic insights, supporting business development, and collaborating across business units for customer solutions.

The ideal candidate will possess an undergraduate degree in a relevant field and a minimum of five years of clinical research experience, including at least three years in a CRO environment. Strong project management skills and experience in trial design are essential.

Qualifications

• Minimum of five years of clinical research experience in project management.
• At least three years in a CRO operations environment.
• Experience designing and managing clinical trials.

Responsibilities

• Lead the development of delivery strategies for clinical trials.
• Support business development and competitive bids.
• Collaborate with CTI business units for customer solutions.

Skills

Clinical Research Experience

Therapeutic Strategy Leadership

Business Development

Project Management

Big Data Analytics

Education

Undergraduate degree in clinical, science, or health-related field

Job description

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. Consider 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)