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Associate Director Clinical Development

Reference Number: 3200
Location: Remote

Our client is an emerging pharmaceutical company.  They have asked us to assist them in their search for an Associate Director, Clinical Development.

Major tasks and responsibilities will include:

  • Manages the Clinical Study operations including in-house team members, consultants, and CRO project team, serve as the key liaison in interactions with Contract Research Organizations (CROs), vendors and other suppliers to achieve project, program, and company goals.
  • Develops and estimates resources (budget, personnel, support staff) required for implementing clinical studies.
  • Collaborates and develops the study specific plans with the CRO project team for the contracted services that will support the project, program, and company goals and will be used to measure performance throughout the project life cycle.
  • Oversees the progress of clinical studies and ensure adherence to study protocols, SOPs, regulatory and internal operating procedures, intended timelines and budget. This includes monitoring and managing of contracted services using both active (team meetings, teleconference calls, etc.) and passive (routine project status reports prepared by each contracted functional area) tools.
  • Works with various in-house functional groups with regards to operational issues of clinical studies including, for example, vendor oversight, safety reporting and processing, study drug supply plans and current status, clinical monitoring, and preparation patient narratives (SAE, Adverse Events of Special Interest, Discontinuations Due to Adverse Events, etc.).
  • Effectively communicates clinical project updates as needed to key stakeholders including Executive Leadership, Departmental Leadership, and external partners or consultants.  Identify and evaluate risk to the project, program, and goal and communicate risks with appropriate mitigation plans to key stakeholders in a timely manner.
  • Becomes expert on the study protocols, and participates in the training and education of internal staff and external vendors, sites and investigators. Ensures the collection of high quality clinical data; primary contributor in the analysis of and summarization of clinical data for assigned studies.  Participates as secondary contributor for other studies as needed.
  • Contributes to the design of clinical protocols that will support the program and company goals.
  • Prepares clinical protocols, protocol amendments, informed consent forms, study guides, case report forms, study plans, and any other clinical study related documents.
  • Contributes to other documents including INDs, IND Annual Updates, DSURs, Investigator Brochures, regulatory meeting documents as needed.
  • Key member of the team that is responsible for the implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
  • Works in a collaborative manner with Clinical Development and Operations, Regulatory and Quality Assurance, Finance, and Project Management personnel, to support clinical quality management activities effectively to accomplish agreed upon deliverables.

We seek candidates with the following qualifications:

  • A minimum of 15 years of relevant clinical experience with extensive experience with compliance issues and strong understanding of FDA regulations, GCP and/ SOPs in pharmaceutical, or biotech environment.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3200. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.