Director of Clinical Research Consulting

Summary

Join Vitalief, a leading site solutions partner, as a client-facing Study Activation Subject Matter Expert. You will play a crucial role in accelerating clinical trial activation, working closely with our delivery team and a premier client. Responsibilities include strategic planning, project oversight, contract negotiation, budget management, and IRB submission preparation. You will build client relationships, support sales efforts, and lead engagement teams. This primarily remote position requires significant clinical research experience and strong leadership skills. Vitalief offers a competitive compensation package including base salary, bonus, and equity incentives.

Requirements

• Bachelor’s degree in related discipline, preferably in life science, healthcare or equivalent qualification
• 10 or more years of Healthcare and/or Clinical Research industry experience
• 2 years of experience and fluent in all activities required for preparing a clinical trial for Site Activation: IRB Submission work (for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials); Regulatory work required for start-up documents; Processes related to study contracts; Processes related to study budget preparation, negotiations, and coverage analyses; Familiar with various “other” start-up activities that are institution specific (i.e., Scientific Review Committee, Disease Focus Groups, Departmental reviews, etc.)
• Hands-on experience completing the following study start-up activities: IRB Submission work for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials; Regulatory work for start-up document; Contract review and negotiation; Budget preparation and negotiation; Obtaining/reviewing study coverage analyses for accuracy; Submission work to various institutional committees outside of the IRB; Ancillary Service start-up as appropriate per protocol
• Demonstrated experience in devising/implementing processes and tools to accelerate the study start-up process
• Dynamic leader with strong executive presence, excellent negotiations skills, and ability to overcome obstacles and gain consensus by pulling teams together to work towards common goals and timeline
• Excellent verbal and written communication and presentation skills
• Delivery team leadership experience including team design, role definition and development, team and culture building, coaching/mentoring, and performance management of team members
• Ability to serve as the single accountable leader in the design and delivery of our innovative Study Activation solutions engagements by creating collaborative, high performing work environments
• Demonstrated ability to build and maintain an extensive professional network, recognize opportunities to enhance and expand executive level relationships, and identify business development opportunities that align with Vitalief’s core set of capabilities
• Proven analytical and critical thinking skills required to effectively quantify financial and operational benefits for performance improvement initiatives, identify risks to achieving projected outcomes, and develop and implement solutions to address data gaps or risks
• Proficient in Microsoft Office (Word, PowerPoint, Excel)
• Highly driven, results oriented, competitive, positive person who thrives in a small, team oriented, fast paced, entrepreneurial environment

Responsibilities

• Represent the pinnacle of consulting success by creating a high-performance environment, inspiring the respect of clients and engagement teams alike. Through strong leadership and unmatched industry expertise within Study Activation, ensure Vitalief’s success and shape the industry
• Provide strategic planning and project oversight accelerating our client’s Study Activation through best-in-class project management to ensure fast site activation for patient enrollment
• Help our clients evolve and adapt to the rapid demands of the research and clinical trials environment, optimizing existing business operations by partnering with key client stakeholders to develop, direct and manage the execution of the strategic, operational and financial delivery of required Clinical Trials Study Activation activities
• Perform the following Study Activation functions: Contract negotiation; Budget preparation and negotiation (with Sponsor, in collaboration with internal teams; Validate study feasibility (taking into account participant enrollment viability, support resourcing needs, alignment with study timeline, competing trials and populations, etc.); Preparation for IRB submission and follow through to approval; Final Preparation - Final approvals by the Principal Investigator & Sponsor
• Take a lead role in developing long-standing relationships with clients by providing quality services and solutions to meet business objectives
• Provide sales support by working closely with Vitalief’s Business Development Team to provide innovative solutions (and proposals) for our prospects and clients
• Work closely with the Talent Acquisition team to qualify the right team to ensure successfully delivery
• Serve as an engagement leader (functioning as a player-coach), working closely with client senior leaders and directing the Vitalief delivery team, ensuring the overall success of the project
• Work with Vitalief’s Senior Management Team and Marketing to proactively identify market trends and industry challenges, then package service offerings to optimize the growth of Study Activation (for example) as a profit center
• Work with Marketing to ensure the Vitalief message is relevant (i.e., Initiate white papers, speaking at industry events, conduct podcasts as a subject matter expert)
• Represent Vitalief at relevant industry trade shows and networking events

Preferred Qualifications

• Any Organizational Change Management (OCM) experience and formal training is a huge plus
• Prior P&L responsibility is a plus

Benefits

• Very competitive compensation program = Base Salary + Bonus + Equity Incentives!
• This is primarily a remote position and must be willing to travel on occasion (up to 20%) to client locations and industry conferences within the USA