Director, Clinical Operations

Location
London, United Kingdom
Posted
Jun 08, 2021
Ref
0CE3D3305E
Required Education
Associate Degree
Position Type
Full time
Reporting to: Sn Director / Vice President, Clinical Operations & Data Management

Location: London

Clinical Operations & Data Management sits within Clinical Development at Orchard, along with Pharmacovigilance, Medical Affairs, Biostatistics and Clinical Science. Clinical Operations are a critical component in all studies to ensure proper planning, conduct, patient safety, and data quality. Orchard's study delivery model is hybrid outsourcing; Clinical Operations therefore have a responsibility for fostering excellent communications between sponsor, investigator site(s) and vendor(s).

Reporting to the Sn Director / Vice President, Head of Clinical Operations & Data Management, the Director, Clinical Operations (DCO) is responsible for overseeing Clinical Operations for one or more programs of the Orchard portfolio as required.

The DCO will input into the strategy, design, feasibility and operational planning, resulting in the production of business-focused clinical drug development programs.

The DCO has direct reports to support them in managing individual studies within the development programs.

Responsibilities

Program Level
  • Lead clinical operations activities at program level for assigned program(s). Co-ordinate the activities across studies within a program to ensure delivery per agreed timelines, budget and quality standards (notably ICH E6 R2 but also specific local and ATMP &/or GT guidelines) to meet program objectives
    • Overall responsibility for clinical operations program budget planning and implementation
  • Provide clinical operations expertise to the Program Team(s) in order to develop robust development plans with achievable milestones, e.g.:
    • Reviewing clinical protocols for operational feasibility
    • Input to program timelines and financial forecast
    • Investigator site selection and qualification
  • In collaboration with Quality and Procurement, lead the vendor selection process and establish governance at study, program or portfolio level as appropriate, implementing KPIs to monitor performance
    • First point of escalation for Study Managers facing challenges with vendors and/or investigator sites
    • Negotiating with and influencing vendors to drive business results
  • Identify and leverage cross-program synergies between studies in order to realise efficiencies
  • Form strong strategic alliances with the other Clinical Development functions in order to optimise study delivery
  • Cultivate partnerships with cross-functional stakeholders such as Regulatory Affairs, Technical Operations, Finance and Business Development in order to solve complex challenges with cross-functional impact

Line Management
  • Line management of Clinical Study Managers and if applicable, In-house Clinical Research Associates and / or CTAs
    • Recruiting and hiring talent to fill open positions
    • Providing training and support to new hires
    • Providing coaching and performance feedback to all team members
    • Communicating and ensuring understanding of functional or departmental goals
    • Monitoring team metrics and performance versus targets
    • Identifying the need for corrective actions
    • Inputting into quality standards for all processes
    • Evaluating overall team and individual performance and delivering performance reviews
    • Engaging and coordinating with other line managers across the organization (e.g. supporting recruitment in other teams)
  • Recruitment and oversight of temporary consultants as required
  • Department
  • - Deliver updates and information to Orchard leadership that will facilitate sound decision-making - Make recommendations for study assignments and identify resource gaps early - Cascades functional strategy and contributes to development of new organisational policies o Accountable for inspection readiness preparedness within Clinical Operations for assigned program(s) - Leads departmental and interdepartmental initiatives as appropriate o Ambassadors for change - Represent Clinical Operations internally - Represent Orchard at external events


Requirements

Experience Required
  • Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key opinion leaders, and investigators
  • Demonstrated ability to work well in teams in a cross functional manner
  • Leadership experience preferably within an operations function in a fast-growing, early-stage life sciences company
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Excellent experience & knowledge of clinical project management
  • Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
  • Experience in managing budgets
  • Proven ability to develop innovative solutions for increased productivity
  • Ability to streamline and implement new structures and roles that create speed, efficiency, and support rapidly shifting business demands
  • Understanding of regulatory environment, GCP/ICH/ATIMP
  • Experience working in an academic environment is a plus, as well as experience in orphan disease field

Education & skills
  • BsC in life sciences
  • Msc/PhD in life sciences is a plus
  • 15+ years' experience in the life sciences industry and demonstrated experience of programme and line management (multiple personnel)
  • Excellent leadership, organisational and communication skills;
  • Comfortable in a fast-paced biotech environment, able to adjust workload based upon changing priorities and self-driven