Role Overview for VP, Clinical Development Operations with a Rare Disease Biotech – St. Louis, MO
JRG Partners is proud to partner with a pioneering, clinical-stage biotechnology company dedicated to developing life-changing therapies for patients with rare and ultra-rare diseases. Located in the burgeoning biotech hub of St. Louis, MO, our client is at the forefront of genetic medicine, leveraging a proprietary platform to address conditions with significant unmet medical needs. Their patient-centric culture and commitment to scientific excellence have created a dynamic, fast-paced environment where innovation thrives.
We are seeking a visionary and experienced Vice President of Clinical Development Operations to join their executive leadership team. This is a critical, strategic role responsible for providing leadership and oversight for all aspects of clinical trial execution. The successful candidate will be a hands-on leader, capable of building and scaling a world-class clinical operations function. Reporting directly to the Chief Medical Officer, the VP will be instrumental in driving the company’s clinical programs from early-stage development through to successful regulatory submission and commercial launch. This individual will ensure that all clinical trials are conducted with the highest standards of quality, on time, and within budget, ultimately bringing hope and new treatments to patients and families affected by devastating rare diseases. This position offers a unique opportunity to shape the future of a promising biotech company and make a tangible impact on global health.
The ideal candidate will possess a profound understanding of the complexities of global clinical development, particularly within the rare disease space. You will be a master of translating corporate strategy into operational reality, fostering a culture of accountability, collaboration, and continuous improvement. Your leadership will extend beyond the clinical operations team, as you will serve as a key partner to cross-functional leaders in Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and Program Management. Your expertise will guide the company through the challenges of rapid growth and evolving regulatory landscapes, ensuring operational readiness and flawless execution of their ambitious clinical portfolio.
Key Responsibilities of VP, Clinical Development Operations with a Rare Disease Biotech – St. Louis, MO
Strategic Leadership and Planning
Develop and implement the long-term strategic vision for the Clinical Operations department, ensuring full alignment with the company’s overall corporate goals and clinical development plans. Proactively identify and address potential risks, resource constraints, and operational challenges. Drive the adoption of innovative technologies and methodologies to enhance trial efficiency and data quality.
Clinical Trial Oversight and Execution
Provide executive oversight for the planning, implementation, and management of all clinical trials, from Phase I through Phase IV. Ensure that all studies are executed in accordance with the highest scientific and ethical standards, on schedule, and within the allocated budget. You will be accountable for meeting key study milestones, including site activation, patient enrollment, data collection, and database lock.
Team Leadership and Development
Recruit, mentor, and lead a high-performing team of clinical operations professionals. Foster a collaborative, inclusive, and performance-driven culture. Provide clear direction, set ambitious goals, and support the professional growth and development of each team member. Scale the team’s capabilities to meet the demands of a growing and increasingly complex clinical pipeline.
Vendor and CRO Management
Lead the selection, negotiation, and management of Contract Research Organizations (CROs), central laboratories, and other third-party vendors. Establish robust oversight mechanisms to ensure vendors meet contractual obligations, quality standards, and performance metrics. Cultivate strong, collaborative partnerships to ensure seamless execution and delivery of services.
Budgetary and Financial Accountability
Develop and manage the annual clinical operations budget, including trial-specific costs and departmental overhead. Provide accurate financial forecasting and variance analysis. Ensure prudent fiscal management and resource allocation to maximize the value of the company’s investments in clinical development.
Regulatory Compliance and Quality Assurance
Guarantee that all clinical trial activities are conducted in strict compliance with international regulations, including Good Clinical Practice (GCP), ICH guidelines, and other applicable regulatory requirements. Oversee the development and implementation of Standard Operating Procedures (SOPs) and quality systems. Prepare for and successfully manage regulatory inspections (e.g., FDA, EMA).
Cross-Functional Collaboration
Serve as a key member of the clinical development leadership team, working seamlessly with colleagues in Clinical Science, Regulatory Affairs, Medical Affairs, Biometrics, and Project Management. Ensure effective communication and alignment across all functions to achieve program objectives. Provide operational expertise and input into clinical development plans, study protocols, and regulatory submissions.
Process Improvement and Innovation
Champion a culture of continuous improvement within the clinical operations function. Identify opportunities to streamline processes, enhance efficiency, and leverage new technologies. Stay abreast of industry trends and best practices to ensure the company remains at the cutting edge of clinical trial execution.
Requirements for the VP, Clinical Development Operations with a Rare Disease Biotech – St. Louis, MO
Educational Background
An advanced degree (MS, PhD, PharmD, MD) in a relevant life sciences or healthcare discipline is required.
Professional Experience
A minimum of 15 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 10 years in a leadership role within clinical operations.
Rare Disease Expertise
Demonstrable, in-depth experience managing clinical trials in rare disease or orphan indications is essential. A strong understanding of the unique challenges associated with patient recruitment, site selection, and trial design in this space is critical.
Global Trial Management
Proven track record of successfully leading and executing complex, multi-center, global clinical trials across all phases of development (Phase I-IV).
Regulatory Acumen
Extensive knowledge of GCP, ICH guidelines, and global regulatory requirements (FDA, EMA, etc.). Experience preparing for and participating in regulatory inspections is required. Experience with successful NDA/BLA/MAA submissions is highly preferred.
Leadership Skills
Exceptional leadership, mentoring, and team-building skills with a demonstrated ability to inspire and motivate a diverse team. Must be a strategic thinker with the ability to operate tactically.
Financial Management
Strong experience in budget development, financial forecasting, and resource management for a clinical operations department and its associated trials.
Communication and Interpersonal Skills
Outstanding written and verbal communication skills. The ability to effectively present complex information to executive leadership, project teams, and external stakeholders. Strong negotiation and influencing skills are a must.
Personal Attributes
A high level of integrity, a strong sense of urgency, and a results-oriented mindset. Must be adaptable and able to thrive in a dynamic, fast-paced, and collaborative biotech environment. Willingness to travel as required to meet business needs.
Benefits & Perks Offered
Our client believes in investing in their people and offers a highly competitive and comprehensive benefits package designed to support the well-being and professional growth of their employees. As a key member of the leadership team, you can expect:
Competitive Compensation
A highly attractive compensation package including a competitive base salary, a significant annual performance-based bonus, and a substantial long-term equity incentive plan (stock options/RSUs).
Comprehensive Health and Wellness
A robust benefits package including premium medical, dental, and vision insurance for you and your dependents, as well as life insurance and disability coverage.
Retirement Savings
A 401(k) retirement plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and paid company holidays, to ensure you have time to rest and recharge.
Professional Development
A strong commitment to your professional growth with support for attending industry conferences, workshops, and continuing education courses.
Relocation Assistance
A comprehensive relocation package is available for the ideal candidate to facilitate a smooth transition to the vibrant St. Louis area.
Impactful Mission
The unparalleled opportunity to work on transformative therapies that will make a profound difference in the lives of patients with rare diseases. Your work will have a direct and lasting impact.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. If you are a visionary clinical operations leader with a passion for rare diseases and a desire to build something truly impactful, we invite you to apply for this exceptional opportunity.
To be considered for this pivotal role, please submit your curriculum vitae and a detailed cover letter outlining your relevant experience and leadership philosophy. All inquiries and applications will be handled with the strictest confidence. For more information about our dedicated expertise in recruiting top-tier talent for the life sciences sector, please visit our Life Sciences and Biotechnology Practice Area page. We look forward to connecting with you.
