Director, Clinical Operations

Employer
Neuraly Inc
Location
Germantown, MD
Posted
Apr 19, 2019
Required Education
Bachelors Degree
Position Type
Full time

Position

This is a full-time, salaried position reporting directly to the Head of R&D.  The Director, Clinical Operations will have responsibility for oversight of clinical trials with sites in the US, Canada, and the EU.  He or she will manage clinical sites, oversee CRO services and balance, and assure necessary communication with regulatory, clinical, and manufacturing. This position provides an opportunity to lead clinical operations for studies based both in the US and abroad across a broad number of products and indications.

Responsibilities

  • Leads the operational strategy, planning, execution and oversight of one or more concurrent clinical programs in accordance with the product development plan
  • Coordinates Clinical Operations program-level resource and activity plans to achieve Project Management milestones and deliverables.
  • Reviews/writes/contributes to key operational sections of clinical study protocols
  • Reviews/writes/contributes to the development of essential study documents (e.g. investigator’s brochure, informed consent form, Clinical Monitoring Plan, Data Management Plan, Statistical Analysis Plan, Risk Management Plan), guidelines, tools, instructions, forms, newsletters, and data collection instruments (e.g. [e]COA, [e]CRF)
  • Defines and oversees collection and monitoring of key program-level performance metrics
  • Identifies and manages key program-level risks, monitors risk indicators and develops contingencies when necessary to keep program on track
  • Ensures vendors selected to support clinical development program are qualified according to SOPs and manages/escalates vendor performances issues in a timely manner
  • Develops status reports and participates in the dissemination of clinical information to internal stakeholders
  • Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
  • Has overall accountability for ensuring operational aspects of the clinical program are inspection-ready. 
  • Coordinates and leads cross functional teams as needed
  • Reviews and approves corrective action plans at individual sites and across studies, may participate in internal/external study related audits and inspections
  • Mentors direct reports, indirect reports, trains team members, including vendors, as needed
  • Contributes to the development and review of standard operating procedures governing clinical study activities

 

Education & Experience

Minimum Requirement: 

  • Bachelor’s degree in health science or related field
  • 8 years experience in pharmaceutical development with at least 3 years directly managing clinical service providers/contract research organizations
  • 3 years direct line management experience

Preferred: 

  • Post-graduate degree in health science or related field
  • 12 years related experience in pharmaceutical development

Competencies & Skills

  • Detail oriented with strong problem solving and decision making skills
  • Ability to provide appropriate leadership to staff 
  • Ability to adapt under pressure
  • Ability to prioritize multiple tasks and responsibilities for self and others simultaneously
  • Excellent verbal and written communication skills
  • Ability to lead and facilitate meetings and technical discussions
  • Expert knowledge of relevant regulations and guidelines (21 CFR 312, HIPAA, ICH GCP, GDP, European Clinical Trials Directive, ISO standards)
  • Requires minimal instruction and typically determines own course of action when given new assignments and upon completion of standard role-based/project level training
  • Ability to travel up to 25%