Director, Therapeutic Strategy Lead - Level Dependent on Experience

CTI Clinical Trial and Consulting Services; Raleigh (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is seeking a Therapeutic Strategy Leader to drive trial oversight and growth across therapeutic areas. You will lead strategy development, engage with clients, and support proposals, bids, and budgets across multi-service lines.

The role requires five years in clinical research and CRO operations, with experience in RFP processes and cross-functional collaboration. Travel up to 30% and potential international travel may be required.

Qualifications

• Undergraduate degree in clinical, science, or health-related field.
• Minimum of five years in clinical research project management with CRO ops experience.
• Experience designing and managing trials across therapeutic areas.
• Experience with big data analytics for study design and enrollment modeling.

Responsibilities

• Lead therapeutic strategy, monitor trends, and guide trial oversight.
• Support early engagement, business development growth, and aligned trials.
• Collaborate with CTI units for end-to-end therapeutically aligned solutions.
• Contribute to RFIs/RFPs and bid defense content, including budgets.
• Provide insights for proposal strategies; travel up to 30%, possible international travel.

Skills

Therapeutic Strategy

Business Development

Clinical Oversight

Bid Defense

RFIs/RFPs

Education

Bachelor’s degree in clinical/science/health

Job description

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