Career Detail

Vice President, Clinical Operations

Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.

Our lead therapeutics are in the following indications:

  • Spinal Fusion
  • Long Bone Repair
  • Osteochondral Repair
  • Dental and Facial Bone Repair
  • Immuno-Oncology

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.




We are seeking a highly skilled and experienced VP of Clinical Operations with a strong background in clinical strategy. This position will play a pivotal role in driving the success of our clinical programs while supporting the highest standards of quality and compliance. Reporting directly to the CEO, this position will lead and manage a team responsible for clinical operations and strategy.

The ideal candidate will have extensive experience in executing both pre-clinical and clinical programs for medical devices, biologics, and combination products as well as a deep understanding of the associated quality and regulatory frameworks. They will lead the development, implementation, and execution of a best-in-class Clinical Program for groundbreaking treatments including shaping the clinical strategy and supporting a fully compliant Quality System.



  • Develop and implement strategic plans for clinical programs, ensuring alignment with corporate objectives and regulatory requirements.
  • Assist and work with Regulatory team on direct, early engagement of protocols and study plans with FDA.
  • Oversee the design, execution, and monitoring of clinical trials to meet timelines and milestones.
  • Lead and provide oversight of clinical site relationships, at all levels within a site.
  • Work with KOLs on protocol designs including endpoints and strategy.
  • Manage pre-clinical efforts in conjunction with the Regulatory organization.
  • Engage Ethics Committees and Institutional Review boards for expedient approvals.
  • Establish data management plans with CROs, SAPs, and prepare study reports to FDA.
  • Perform and oversee clinical monitoring.
  • Along with contract statisticians, conduct statistical analyses, as needed, to assess if trials are achieving objectives. Assess if correct statistical methods are used in both pre-clinical and clinical efforts.
  • Coordinate with and manage clinical CROs, establish budgets and control expenses.
  • Assure compliance with Good Clinical Practices.
  • Work with Quality and Regulatory leads to support the establishment and implementation of a robust quality management system (QMS) to ensure study compliance with applicable regulations and industry standards.
  • Conduct audits of clinical sites for FDA inspection readiness.
  • Implement continuous improvement initiatives to enhance the quality and efficiency of trials and integrate SOPs and plans with the Quality organization.
  • Collaborate closely with R&D and Manufacturing teams to integrate clinical, quality, and regulatory considerations into all aspects of product development.
  • Provide strategic guidance to senior leadership on clinical matters.
  • Collaborate on innovative and sustainable medical devices, clinical, and regulatory strategies covering combination products for product development, submissions, and approvals.
  • Support global filing activities for medical devices and combination product submissions. Ensure compliance with regulatory agencies such as FDA, TGA, and other relevant authorities.
  • Stay abreast of changes in clinical, quality, and regulatory requirements and proactively advise the organization on potential impacts.



  • Extensive experience in designing and executing medical device and combination product clinical trials, quality assurance, and regulatory affairs within the biotech or pharmaceutical industry.
  • Led clinical operations teams and overseen all aspects of clinical trial design and implementation including CRO oversight for multiple successful clinical studies.
  • Advanced degree in a relevant scientific discipline (MD, PhD, or equivalent) preferred. Equivalent professional experience will be considered in lieu of formal education.
  • Solid understanding of both device and drug regulations well as combination products.
  • Proven track record of successful leadership in managing and directing cross-functional teams.
  • Extensive experience and in-depth knowledge of global regulatory requirements, with a proven track record of successful interactions with regulatory agencies on a global scale.
  • Strong understanding of quality control, statistics, and biostatistics required.
  • Understanding of the processes of pooling data across sites, demographics, and study Phases.
  • A minimum of 15 years of experience across various medical disciplines, with a preference for experience in spinal fusion, long bone repair, osteochondral, dental/facial, and immuno-oncology.
  • Excellent communication and interpersonal skills, with the ability to influence and negotiate effectively.



  • Preference will be given to applicants who live within a commutable distance to Theradaptive corporate headquarters and laboratory in Frederick, MD. 

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.