Associate Director, Clinical Operations CVMD

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 10/31/17
Gaithersburg, MD
11 - 15 years experience
Salary depends on experience
Posted on 10/31/17
  • Design the clinical operational strategy for the Clinical Development Plan (CDP) with Medical Director
  • Provide expert clinical operational input into:  Target Product Profile (TPP), Clinical Development Plan (CDP), Protocol Concept Sheet (PCS), Clinical Study Protocol (CSP), and Clinical Study Report (CSR), to ensure seamless delivery of studies through effective collaboration
  • Deliver differentiated and robust operational design options for review at Investment Decision Governance interactions (ie. PDT, iMED, Clinical Functional Review, ESPC and others as appropriate)
  • Oversee the operational delivery of the Clinical Study Program(s) from CD Nomination to final CSR and through to study closed and archived to agreed budget, time and quality and aligned with Key Performance Indicators (KPIs)
  • Plan and lead interactions, including issue escalation and  resolution between Clinical Operations, Clinical Trial Teams (CTTs), CST and the PDT/GPT
  • Accountable for driving accurate clinical resource forecasting.
  • Develop and manage clinical program risk and opportunity mitigation plans to ensure delivery to timelines, budget and quality with efficient resource utilization.
  • Review of the CSRs and any regulatory submissions. Co-leads the clinical operational team contribution along with Regulatory
  • Responsible for the initial forecasting and management of all Clinical Operations delivery related costs and oversight for  individual studies
  • Accountable for the quality of study delivery planning information into relevant planning systems (eg:, OPAL, IMPACT) and the direct input of clinical forecasting into OPAL
  • Collaborate with  Sr. Director, Clinical Operations and/or Sr. Director, Clinical Development or TA VP to drive best practices, ensuring project and functional objectives are aligned and cascaded to team members
  • Partner closely with the Medical Director and other members of the CST, to, provide expert clinical operational feasibility input to PCS development.
  • Accountable for overall program deliverables, will maintain oversight of compound’s study deliverables by close interaction with the CPMs who are assigned to the individual trials.
  • Line management of AD/CPM/Sr CPMs.
  • May act as a coach and/or mentor for other more junior staff as needed

Essential Requirements

  • Bachelor of Science/Arts in medical biological science, business or finance or related
  • Minimum 10 years of experience in the pharmaceutical/biotech industry
  • Extensive and proven experience in driving operational delivery to timelines, cost and quality
  • Proven experience leading delivery through collaboration with  internal organization and external providers
  • Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery  
  • Proven ability in proactive problem solving and risk management that is solution focused
  • Proven Global Project Management experience with expertise in program level resource and budget management
  • Experience and strength in working and leading in matrix teams
  • Requires minimal guidance and oversight from the Sr. Director, Clinical Operations and/or Sr. Director, Clinical Development or TA VP
  • Strategic Skills including a high level of creativity, innovation, and problem solving with an ability to manage effectively through ambiguity
  • Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict
  • Manages the Clinical Operations remit within the PDT and/or GPT structure
  • Ability/willingness to lead strategic and/or operational management of individual clinical trials should the need arise
  • Ability to motivate team members and build cross functional teams in support of the PDT/GPT vision
  • Provide strong leadership and facilitation skills to link strategic direction to a clear operation plan
  • The appropriate candidatewill:
    • Act decisively
    • Work collaboratively
    • Exhibit passion for customers
    • Drive performance
    • Think strategically
    • Develop people and organization
    • Possess positive change management skills, at all levels including individually, team and the business, seeing change as an opportunity to improve performance and add value to the business
  • Willingness to travel both domestically and internationally

Desirable Requirements

  • Advanced degree
  • Certification or Degree in Project Management
  • Preferred program level experience across the product life cycle and across multiple therapeutic areas, with experience in global drug development

Job reference: R-012386

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