Director, Clinical Operations

Overview:

Reporting to the Senior Vice President of Clinical Development and Medical Affairs the Senior Director, Clinical Operations is an integral part of the Clinical Development and Medical Affairs team.  He/she will be responsible for leading the development, oversight, coordination, and management of all clinical trial activities to ensure successful execution of these studies in alignment with corporate goals.

Summary of Key Responsibilities:

  • Responsible for resource planning including clinical research organization (CRO) and vendor identification and management
  • Responsible for managing pre- and post-approval clinical trials, including investigator sponsored studies and related activities to ensure execution of those studies
  • Identify and Manage CROs and other consultants to drive execution of clinical trials
  • Establish study milestones and maintain responsibility of study metrics and timelines
  • Ensure trial adherence according to company SOPs, ICH/GCP/Federal and local regulations
  • Develop and/or review and approve clinical operations documents including Study Management Plan, Monitoring Plan, Communication Plan, Safety Oversight Plan, and Data Management Plan
  • Review and approve clinical monitoring visit reports and ensure appropriate follow-up with clinical trial sites
  • Ensure appropriate Investigational Product release as per relevant SOP and completion of essential documentation
  • Manage vendors responsible for shipment of clinical trial materials to study sites
  • Provide operations leadership within the department and adapt to ensure efficiencies in executing clinical development deliverables
  • Review and approve study site budgets and ensure alignment with overall study and program-level budgets
  • Provide oversight of data management activities (monitoring, analysis, review, and reporting of data) in compliance with GCP, SOPs and standards for clinical studies to ensure data integrity
  • Collaborate cross functionally to support Investigator Sponsored Studies program including reviewing protocol synopsis and protocols, contracting, IND submissions, supply of patient education materials, and drug supply management
  • Assist in the preparation of clinical sections of Regulatory Documents including INDs, NDAs, and Annual Reports
  • Participate and respond to Quality Assurance and/or regulatory authority inspection audits
  • Ensure availability of supplies for clinical and non-clinical studies based on protocol/trial needs

Education and Experience Requirements:

  • BA/BS in science or healthcare degree
  • 5+ years of clinical research experience, with experience in project management, monitoring and CRO management
  • 1+ years of clinical data management experience preferred
  • Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required
  • Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required
  • Ability to collaborate effectively with the clinical operations team, cross functional team members and external partners including CROS, Vendors, Investigators and site staff.
  • Understanding and adherence to GCP/ICH guidelines and Investigator-sponsor guidance
  • Understanding and adherence to the Compliance Program Guidance Manual for Sponsors, CROs and Monitors
  • Understanding and adherence to FDA Guidance for Industry on IND Applications Prepared and Submitted by Sponsor-Investigators
  • Understanding and adherence to FDA Guidance for Industry and Investigators on Safety Reporting Requirements for INDs and BA/BE Studies

Skills and Abilities:

  • You are passionate about your work and display a high level of emotional intelligence in your decision making
  • You understand, appreciate and thrive in a growing organization and have the desire to learn new skills to contribute to company success
  • You can manage multiple projects, solve problems, and deliver on commitments
  • You can effectively communicate and interact with Investigators/Sub Investigators and clinical personnel
  • You can understand strategy, transition to execution, and effectively collaborate cross functionally
  • You have excellent communication, customer service, and collaborative skills
  • You strive for excellence and expect the same from your team and colleagues

scPharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.