Role Overview for Head of Clinical Development with a MedTech Company – Baltimore, MD
JRG Partners is proud to represent a pioneering, venture-backed MedTech company based in the vibrant life sciences hub of Baltimore, MD. Our client is at the forefront of developing innovative medical devices that address critical unmet needs and have the potential to revolutionize patient care. They are seeking a visionary and experienced Head of Clinical Development to provide strategic leadership and operational oversight for their entire clinical program portfolio. This is a rare opportunity to join a dynamic executive team and play a pivotal role in shaping the future of the company, guiding novel technologies from early-stage development through to regulatory approval and global market launch.
As the Head of Clinical Development, you will be the ultimate owner of the company’s clinical strategy and execution. You will be responsible for building and leading a high-performing clinical development team, ensuring that all clinical trials are designed and conducted with scientific rigor, operational excellence, and in full compliance with global regulatory standards.
This role requires a unique blend of scientific expertise, strategic thinking, and hands-on leadership. You will be instrumental in generating the robust clinical evidence required to demonstrate the safety and efficacy of our client’s groundbreaking products, directly influencing their commercial success and impact on patients’ lives. The ideal candidate will be a seasoned leader with a proven track record of success in the medical device industry, possessing a deep understanding of the entire product development lifecycle and a passion for innovation.
Key Responsibilities of Head of Clinical Development with a MedTech Company – Baltimore, MD
The Head of Clinical Development will have a broad range of responsibilities, encompassing strategic planning, operational execution, team leadership, and cross-functional collaboration. Your primary goal is to ensure the successful delivery of all clinical programs on time and within budget.
Clinical Strategy and Leadership
Develop and implement the overarching clinical development strategy in alignment with corporate objectives. Provide expert clinical and scientific input to the executive team, board of directors, and key stakeholders. Represent the company at scientific conferences, investor meetings, and regulatory agency interactions.
Trial Design and Execution
Lead the design, planning, and execution of all clinical trials, from feasibility and first-in-human studies to pivotal and post-market trials. Oversee the development of clinical trial protocols, case report forms (CRFs), informed consent forms (ICFs), and other trial-related documentation.
Regulatory Affairs and Compliance
Serve as the primary clinical liaison with global regulatory authorities, including the FDA, EMA, and other bodies. Lead the preparation and submission of regulatory documents, such as Investigational Device Exemptions (IDEs), Premarket Approvals (PMAs), and 510(k)s. Ensure all clinical activities adhere strictly to Good Clinical Practice (GCP), ICH guidelines, and other applicable regulations. A deep understanding of the requirements for an Investigational New Drug (IND) application and its device equivalents is essential.
Team Management and Development
Build, mentor, and manage a world-class clinical development team, including clinical operations, clinical science, data management, and biostatistics functions. Foster a culture of collaboration, innovation, accountability, and scientific excellence.
Data Analysis and Interpretation
Oversee the collection, analysis, and interpretation of clinical trial data. Work closely with biostatisticians and medical writers to ensure accurate and compelling presentation of results for publications, regulatory submissions, and internal decision-making.
Vendor and Site Management
Lead the selection and oversight of Contract Research Organizations (CROs), central labs, and other clinical vendors. Develop strong relationships with key opinion leaders (KOLs) and clinical trial sites to ensure efficient site selection and robust patient enrollment.
Budget and Resource Planning
Develop and manage the annual budget for the clinical development department. Ensure efficient allocation of resources to meet program timelines and corporate goals. Continuously monitor program progress and financial performance, implementing corrective actions as needed.
Cross-Functional Collaboration
Collaborate effectively with R&D, Medical Affairs, Quality Assurance, and Commercial teams to ensure seamless integration of clinical development activities within the overall product development and commercialization plan.
Requirements for the Head of Clinical Development with a MedTech Company – Baltimore, MD
We are seeking a highly qualified and motivated individual with extensive experience in leading clinical development programs within the medical device industry. The successful candidate will possess the following qualifications:
Educational Background
An advanced degree (MD, PhD, or PharmD) is strongly preferred. A bachelor’s or master’s degree in a relevant life sciences field with extensive, directly applicable experience will be considered.
Professional Experience
A minimum of 12-15 years of progressive experience in clinical development within the medical device, pharmaceutical, or biotechnology industry. At least 7 years of experience in a senior leadership role with direct management responsibilities.
Regulatory Expertise
Demonstrated experience leading interactions with the FDA and other global regulatory agencies. A proven track record of successful regulatory submissions (IDE, PMA, 510(k)) for medical devices is essential.
Clinical Trial Management
Extensive hands-on experience in designing, conducting, and managing all phases of clinical trials. Strong knowledge of trial methodologies, biostatistics, and data management principles.
Leadership Skills
Proven ability to build and lead high-performing teams. Exceptional strategic thinking, problem-solving, and decision-making skills. Ability to inspire and motivate others towards a common goal.
Communication Skills
Outstanding written and verbal communication skills. Ability to articulate complex scientific and clinical concepts to a wide range of audiences, from scientific experts to business executives and investors.
Industry Knowledge
Deep understanding of Good Clinical Practice (GCP), ICH guidelines, and the global regulatory landscape for medical devices. Experience in therapeutic areas such as cardiology, orthopedics, or neurology is a plus.
Personal Attributes
A high level of integrity, a strong work ethic, and a passion for improving patient outcomes. Adaptable and able to thrive in a fast-paced, innovative, and resource-constrained startup environment.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a competitive and comprehensive compensation and benefits package. This includes:
- Competitive base salary and annual performance-based bonus.
- Significant equity/stock option package, providing a meaningful stake in the company’s success.
- Comprehensive health, dental, and vision insurance for you and your dependents.
- 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO) policy, including vacation, sick leave, and paid holidays.
- Support for professional development, including attendance at scientific conferences and training courses.
- Relocation assistance for qualified candidates.
- A collaborative, mission-driven work environment where your contributions have a direct impact.
How to Apply
JRG Partners has been exclusively retained for this critical search. If you are a visionary clinical development leader passionate about bringing transformative medical technologies to market, we encourage you to apply. To be considered for this exceptional opportunity, please submit your resume and a cover letter detailing your qualifications and interest in the role.
For more information on similar opportunities or to learn more about our expertise in this sector, please visit the JRG Partners’ Life Sciences practice page. We look forward to reviewing your application and discussing how you can contribute to our client’s success.
