Senior Specialist, Clinical Safety

Job Title: Senior Specialist, Clinical Safety

Role Level: Individual Contributor (IC)

Supervisor/Manager Title: Senior Manager, Clinical and Medical Safety

Job Location & Environment: Irvine, CA – Corporate Office or Remote

Job Description Summary: Reporting to the Senior Manager, Clinical Safety, the Senior Specialist, Clinical Safety independently manages a high volume of concurrent safety activities across multiple active JenaValve clinical trials, including the ARTIST Trial, ALIGN-AR Pivotal Trial, ALIGN-AR EFS Trial, and the JENA-VAD Registry. This role requires the ability to manage a demanding, fast-moving workload across overlapping study timelines and deadlines, while maintaining a high level of accuracy and regulatory compliance. The Senior Specialist takes a lead role in adverse event reporting, CEC/DSMB support, and safety documentation for regulatory submissions, and serves as a subject matter resource and mentor to other members of the Clinical Safety team.

Job Responsibilities:

• Independently manage a high-volume, concurrent safety caseload across multiple active clinical studies with overlapping deadlines; prioritize competing demands with minimal oversight.
• Conduct assessments of adverse events (AEs) and complaints across multiple clinical studies, including UADE (Unanticipated Adverse Device Effect) determinations; perform complaint handling assessments and report AEs per regulatory requirements, trial safety processes, and JenaValve procedures.
• Review and analyze aggregate safety reports to identify early safety signals; proactively escalate findings to leadership with recommended next steps.
• Track timeliness of AE and SAE reporting by investigational sites and follow up as needed to ensure compliance with protocol-specified timelines across multiple concurrent studies.
• Interact with investigational sites and field monitors to obtain additional pertinent information on Case Report Forms and medical documentation (source documents).
• Independently prepare, review, and finalize event narratives and safety data packages for internal review and external reviews (e.g., Clinical Events Committee, Data Safety Monitoring Board) and for regulatory submissions, including IDE Annual Progress Reports.
• Own the safety sections of IDE Annual Progress Reports and other major regulatory submissions end-to-end, including data reconciliation, MedDRA coding oversight, and CEC adjudication status tracking, under tight submission timelines.
• Build and deliver recurring and ad hoc safety presentations and dashboards for leadership, DSMB, and CEC audiences, condensing high volumes of safety data into clear, decision-ready materials.
• Serve as a subject matter resource for the MedDRA coding team on complex coding questions; participate in and help lead MedDRA coding team meetings.
• Provide clinical and medical subject matter expertise to address safety-related questions from internal study teams, field support personnel, monitors, and study sites across concurrent studies.
• Contribute to clinical aspects of protocol development, including drafting the Safety section of clinical trial protocols, adverse event definitions, AE reporting requirements, and risk sections.
• Collaborate with data management and cross-functional teams on the development of case report forms, study-specific safety reports, and other study forms, ensuring alignment with clinical definitions and EDC data flows.
• Support DSMB and CEC startup and ongoing management activities, including vendor selection and approval, member selection, charter development, and meeting materials.
• Respond to regulatory authority inquiries regarding safety data (e.g., discrepancy queries) with accurate, well-documented responses.
• Mentor and provide guidance to other Clinical Safety team members, including training on safety data entry, AE data cleaning, and safety review processes.
• Contribute to other clinical and medical affairs activities as needed and support continuous process improvement, including workflow efficiencies to manage rising case volume.
• Complete training for internal SOPs and maintain current knowledge required for the role.

Required Education and Experience:

• 5+ years in a clinical safety or pharmacovigilance role; medical device experience strongly preferred.

• Bachelor's degree or higher in a life sciences, health sciences, or related field required; advanced clinical degree (NP, PA, MD, or international equivalent) highly preferred.

• Demonstrated experience independently managing a high volume of concurrent safety deliverables across multiple studies in a fast-paced, deadline-driven environment.

• Working knowledge of HIPAA, ICH, GCP, and regulatory requirements related to clinical research.

• Experience with cardiovascular or structural heart therapeutic areas is a significant advantage.

• Strong organizational skills and time management abilities; proven ability to manage multiple concurrent priorities and shifting deadlines without loss of accuracy.

• Excellent critical thinking skills and strong written and verbal communication skills.

• Self-motivated, detail-oriented, and able to work independently as well as part of a collaborative team; comfortable operating with a high degree of autonomy.

Skills and Abilities Required for This Job:

• Clinical knowledge in cardiology; structural heart disease or transcatheter valve therapy experience preferred.

• Knowledge of GCPs governing clinical trial conduct; working knowledge of medical device regulations and ICH guidelines.

• Experience working across all phases of clinical study conduct from a clinical safety perspective, including regulatory submission cycles (e.g., IDE Annual Progress Reports).

• Demonstrated ability to manage a high-volume, concurrent workload across multiple studies and competing deadlines without sacrificing data quality or compliance.

• Familiarity with MedDRA coding, adverse event terminology, and safety database management.

• Experience with EDC (Electronic Data Capture) platforms for clinical trial management and safety reporting.

• Basic understanding of clinical trial design and statistical concepts as applied to safety evaluation.

• Ability to work collaboratively as part of a multi-functional medical device development team, and to mentor less experienced team members.

• Excellent oral and written communication skills; strong interpersonal skills and ability to work effectively cross-functionally and cross-culturally.

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• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Physical Requirements:

• Standard office environment requirements, including prolonged periods of sitting and computer use.

• Ability to manage a sustained, high-volume workload under recurring deadlines.

• Minimal travel, up to 10%.