Senior Director, Clinical Operations

Location
94080, South San Francisco
Posted
Sep 24, 2018
Discipline
Clinical
Required Education
Masters Degree/MBA
Position Type
Full time

Description:

Pliant Therapeutics is an early stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases.  Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar for progress to meet unmet medical needs for patients and physicians.  The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.  The Company is seeking passionate, creative and dedicated scientists to join our team and contribute to our mission. 

Position Overview

Pliant is seeking a Senior Director of Clinical Operations to provide strategic direction and leadership for the execution of clinical trials. The successful candidate will also be responsible for the day to day management of clinical operations. This role will ensure the delivery of appropriately skilled resources so that trials are delivered according to corporate objectives. The Senior Director will provide strategic direction and leadership for the execution of trials and ensure successful delivery of clinical study milestones. This role will also oversee vendor activities with appropriate risk mitigations and contingency planning.

Primary Responsibilities:

  • Primary operational leader of the clinical program implementation
  • Participate in resource allocation, prioritization and budgeting to ensure department goals and milestones are aligned and tracking to corporate objectives. Line management responsibilities include hiring talent, performance development and mentorship
  • Ensure ongoing strong vendor interactions and collaborations, including hands-on interactions and management 
  • Drive selection of vendors and vendor project organization
  • Vendor, PI and project team management, oversight & communication
  • Serve as primary contact for functional area representatives in managing protocol execution
  • Develop and manage integrated study timelines and leads study strategy meetings to review trial status/progress
  • Provide input on strategy in the development of realistic project milestones and deliverables. Apply appropriate project management tools and processes
  • Multicenter and multinational trial management, principally focused on IPF and PSC
  • Manage labeling and distribution logistics for clinical supplies
  • Lead ongoing risk assessments with accompanying mitigation plans and contingency plans. Strong abilities to problem-solve and diagnose the root causes and implement the appropriate corrective actions
  • Provide input to the development and review of study and overall clinical program budgets. Take corrective measures as necessary to keep project(s) in line within agreed timelines, quality, budget and performance metrics. Assess the impact of project scope changes to understand the implications on agreed plans and budgets.
  • Manage interdisciplinary activities to ensure clinical operations collaborates effectively to set achievable goals, milestones and timelines.  Establish strong cross-functional relationships and manage cross functional resources and study deliverables.
  • Identify and implement best practices and leverage lessons learnt and process improvements 
  • Ensures trial adherence to ICH/GCP/local regulations
  • Author/review study documents (Protocol, ICF, IB, Monitoring plans, SMC/IDMC/DSMB charter, CSR, statistical analysis plan)

Requirements:

  • Master’s degree, preferably in health care, life sciences, or related discipline
  • A minimum of 10 years of Clinical operations experience within the Biotech/Pharmaceutical industry
  • A minimum of 6 years of staff management and vendor management experience
  • Thorough understanding of the processes associated with executing a clinical development program including: clinical trial design, implementation, management and reporting
  • Advanced leadership, project management, resource management, administrative and technical capabilities
  • Excellent verbal and written communication skills
  • Experience with early and late phase clinical trials
  • Experience with IPF, PSC and rare diseases are a definite plus
  • Experience in direct or matrix management of clinical operations team member
  • Knowledge of the drug development process in the bio/pharmaceutical industry with an understanding of relevant regulatory requirements
  • Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
  • Strong project management skills with effective written and verbal
  • communication skills
  • A team player with excellent interpersonal skills and the ability to serve as the key interface for the organization on an operational level
  • Substantial experience managing contractors and interacting effectively in the establishment, oversight and maintenance of vendor relationships
  • Knowledge of GCP and ICH required, global clinical management experience preferred
  • Proficient computer skills
  • Understanding of financial principles and budget management
  • Ability to communicate with and manage senior-level stakeholder objectives

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