Description:
This is an exciting opportunity to work for a small, friendly, fast-paced start-up medical device company with a motivating mission to help babies born with congenital heart disease by developing best-in-class devices. The company is headquartered in San Diego, CA and maintains a network of advisors, active board members, academic, and industry partnerships in support of device development. This role is a full-time position for Head of Clinical. The specific title — Senior Manager, Director, or Vice President of Clinical — will be determined based on the experience of the selected candidate. Starlight is seeking an experienced clinical professional to serve as the company's clinical expert, owning the execution of pre- and post-approval clinical studies supporting the company's first-in-class implantable devices for infants born with congenital heart disease. Candidates with relevant experience may also own the clinical trial strategy and design future trials, either now or in the future. The ideal candidate is an independent, hands-on clinical professional who thrives in a small, fast-paced startup environment and is comfortable with personally executing day-to-day study operations. Responsibilities include directing pre-approval (early feasibility and pivotal IDE) and post-approval (post-approval study and registry) clinical programs, serving as a primary point of contact with clinical trial sites for data collection. Experienced candidates may also develop the clinical strategy, design clinical trials, serve as the primary clinical contact with FDA, and build the clinical affairs function as the company scales. The scope of strategy, team-building, external representation (e.g., with the Board, investors, FDA, and key opinion leaders), and decision-making authority for this role will expand with the experience level of the candidate hired.
Key Responsibilities:
Serve as the company's clinical expert, providing clinical strategy and judgment across R&D, Regulatory, Quality, and Marketing.
Own the execution of pre-approval clinical studies (early feasibility studies, pivotal IDE trials) for the company's Class III implantable pediatric cardiovascular device.
Own the execution of post-approval clinical activities, including post-approval studies (PAS), registries, and post-market surveillance.
Author clinical study protocols, informed consent documents, and case report forms.
Select, manage, and coordinate with CROs, core laboratories, biostatisticians, Data Safety Monitoring Boards (DSMB), and Clinical Events Committees (CEC).Lead site selection, site initiation, training, and ongoing management of clinical sites and investigator relationships.
Oversee clinical data collection, monitoring, and quality control to ensure data integrity supporting regulatory submissions.
Prepare clinical sections of regulatory submissions, including IDE applications, PMA modules, and annual/periodic reports.
Track clinical study budgets, timelines, and enrollment against milestones, and report progress to leadership.
Ensure all clinical programs comply with Good Clinical Practice (GCP), ISO 14155, FDA regulations, and applicable international requirements.
Collaborate cross-functionally with R&D, Regulatory, Quality, and Marketing teams to generate clinical evidence supporting product development and commercialization.
Understand, embrace, and ensure compliance with the company's Quality System and applicable government and industry regulations, and travel to clinical sites and company headquarters as needed.
Experienced candidates may own the strategy and design of pre- and post-approval clinical activities.
Experienced candidates may serve as a primary clinical point of contact with the FDA, including supporting or leading pre-submission meetings, IDE submissions, and PMA clinical sections.
Experienced candidates may coordinate with biostatisticians on study design, sample size calculations, and statistical analysis plans.
Present clinical strategy, study progress, and clinical data to leadership and, depending on seniority, the Board of Directors and investors; provide clinical input into product design, risk management, and labeling.
Support or lead (depending on seniority) key opinion leader (KOL) engagement, clinical publications, and presentations at scientific and medical conferences.
Build, lead, and mentor the clinical affairs function as the organization scales, to the extent called for by the seniority of this role.
Basic Qualifications:
This role will be titled and leveled — Senior Manager, Director, or Vice President of Clinical — based on the experience, scope of prior responsibility, and readiness of the selected candidate:
Senior Manager of Clinical: 6+ years of relevant clinical affairs/research experience.
Director of Clinical Affairs: 8+ years, including experience designing and managing IDE and post-approval studies.
Vice President of Clinical: 12+ years, including a proven track record leading pivotal IDE trials and post-approval studies for Class III implantable devices through FDA approval (PMA), and experience building and leading a clinical function.
Minimum of 5 years of experience in clinical affairs or clinical research within the medical device industry; experience with Class III or implantable devices strongly preferred.
Demonstrated experience managing IDE and post-approval clinical studies.
Experience designing IDE studies for new products desired.
BS/BA degree required; advanced degree (MS, PhD, RN, or related field) preferred.
Working knowledge of FDA regulatory requirements, GCP, and ISO 14155; Director/VP-level candidates should have hands-on FDA experience (pre-submission meetings, IDE applications, PMA submissions).Strong organizational skills and excellent written and verbal communication skills, including protocol and regulatory document writing.
Ability to work independently and manage multiple study workstreams; Director/VP-level candidates should also bring experience representing a company externally with KOLs, investigators, investors, and regulators.
Experience with program, portfolio or people management desired.
Experience in pediatric cardiology, congenital heart disease, or structural heart is a plus.
Experience supporting clinical cases in the catheterization laboratory is a plus.
Job Type: Full-Time
Expected Hours: 40+ per week
Pay: Salaried, commensurate with experience and level
Work Location:
On-site in San Diego, CA preferred; flexible/remote arrangements will be considered for the right candidate, with regular travel to company headquarters and clinical study sites
