Director of Clinical Research Consulting

Overview Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. We are seeking client facing, problem-solving, hands-on and strategic clinical research professional to become an integral member of our exceptional Client Services Delivery Team. The initial focus of this role will be to function as a Study Activation Subject Matter Expert (SME), working closely with Vitaliefs delivery team and one of our premier clients to significantly reduce their time to trial activation. Why Vitalief?

• Working at Vitalief will provide you with an opportunity to significantly contribute to our growth and recognition in the clinical research industry by fulfilling our clients business needs through our innovative consulting solutions.

• Our team of real-world practitioners brings business and domain expertise to provide more efficient, higher-quality clinical trials and unmatched value to Sponsors, CROs, academic sites, independent sites, and site networks. Our unique, fully integrated, and customized approach accelerates and enhances clinical research.

• Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees; and we encourage challenging the status quo with novel thinking.

• We offer a 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.

• Join a culture that is highly collaborative, entrepreneurial, and enthusiastic about expediting the growth of Vitalief and be highly rewarded for our accomplishments as a team.

Responsibilities:

• You 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 Vitaliefs success and shape the industry.

• Provide strategic planning and project oversight accelerating our clients 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 Vitaliefs 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 Vitaliefs 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.

Required Skills:

• Bachelors 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.

• Any Organizational Change Management (OCM) experience and formal training is a huge plus.

• 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 Vitaliefs 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.

• Prior P&L responsibility is a plus.

• 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.

PHYSICAL DEMANDS: Prolonged periods of sitting at a desk and working on a computer. Standing, walking, visual perception, talking and hearing. Lifting up to 20lbs. Limited travel to various physical locations within the USA.