Full-Time

Associate Director

Immunoassay

Confirmed live in the last 24 hours

Sarepta

Sarepta

Compensation Overview

$156k - $195kAnnually

Senior

United States

Hybrid position requiring on-site work at Sarepta’s facilities in the United States.

Category
Diagnostics & Laboratory Professionals
Medical, Clinical & Veterinary
Required Skills
Word/Pages/Docs
Google Cloud Platform
Excel/Numbers/Sheets
PowerPoint/Keynote/Slides
Requirements
  • Experience managing a clinical study with a Companion Diagnostic (CDx) and/or in vitro diagnostic (IVD)
  • Experience in management of CROs, vendors and consultants
  • Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies
  • Experience developing IVD trial plans including informed consent, site management, risk mitigation strategies, trial budgets and program-level budgets
  • Proficient written and verbal communication skills
  • Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
  • Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
  • Position may require some travel
  • Bachelor’s degree in health sciences or related field
  • Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management with strong experience with CDx and/or IVD studies, study phases I-IV, global trials, and with complex trial designs
  • Program-level experience preferred.
  • Rare disease experience preferred.
  • Line management experience preferred.
Responsibilities
  • Serve as the subject matter expert within clinical operations for the planning and execution of IA studies across all phases
  • May provide project oversight to IA studies on a large program
  • Oversee Clinical Research Organizations (CROs), vendors and consultants involved with the IA clinical trials
  • Serves as the point of contact for protocol execution
  • May participate in the Clinical Trial Team (CTT) and/or the program Clinical Sub Team
  • May support the Clinical Operations Program Lead (COPL) to operationalize and execute the Clinical Development Plan (CDP)
  • Oversee junior team members and ensure alignment with any supporting COLs assigned to studies
  • Establishes the IA study timelines in line with the therapeutic study timelines and the company goals and ensures accurate tracking and reporting of IA study metrics and progress through completion of study dashboards
  • Works cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated to the Clinical Operations Program Lead (COPL)
  • Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
  • Develops, reviews and/or consults on reports and clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates
  • Responsible for communication and escalation of IA study related issues to the COPL
  • Provides enrollment forecasting to the COPL in alignment with the therapeutic study
  • Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed, or delegates activity with oversight
  • Participates in and responds to Quality Assurance and/or regulatory authority inspection audits
  • In conjunction with CRO and appropriate internal stakeholders, facilitates the development of trial budgets and execution of clinical trial agreements and other relevant documents
  • Manages the clinical trial budget and provides financial reporting and projections to Finance
  • Leads creation of scope of work and budgets and escalates vendor performance issues to COPL and Procurement as necessary
  • May serve as an escalation point for more clinical operations team study team members internally and with vendors
  • Assume leadership role in operational improvement initiatives (e.g., SOP development, training etc.)

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

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