Clinical Lead

at  Barinthus Biotherapeutics

KEY SKILLS REQUIRED

• Wider experience in process redevelopment, system and tool development and organisational evolution will be an advantage
• Good working knowledge of project management software including MS Project and Excel
• Demonstrated ability to line manage effectively and sympathetically
• Personal credibility - personal impact, knowledge, ability to understand and respond to clinical programme and business requirements, ability to challenge as appropriate without causing undue confrontation.
• Takes accountability: - “Can do” attitude with strong focus and commitment to delivering.
• Personal integrity and professionalism; open and straight forward style.
• Excellent leadership skills - able to inspire and lead others to exceed their potential without needing line management authority.
• Excellent interpersonal skills - strong cross-functional influencing, negotiating and teamworking skills. A collaborative manner is essential.
• A logical as well as creative thinker with good attention to detail
• Able to make strategic as well as tactical decisions.
• A highly effective communicator
• Demonstrates personal drive and goal orientation.
• Self-motivated taking satisfaction in delivering on personal and corporate objectives.
• Able to motivate others to perform and deliver to timelines and quality whilst maintaining a good team culture and morale.
• Enthusiastic and flexible with openness to change and ability to support teams with change management.
• Willingness to utilise their wider experience to further Barinthus Bio’s growth and delivery, even if outside of the Clinical Lead remit, when time allows
• Demonstrates strong organisational and prioritisation skills to manage a diverse workload.
• Able to interact with individuals at all levels of the organisation.

MAIN PURPOSE OF THE ROLE

• Take overall accountability for successful delivery for all clinical studies within assigned programmes. This will usually be done via direction and guidance of Clinical Study Managers and their oversight of clinical service providers in delivery of services.
• Provide key clinical and study operational insight into clinical development and programme strategy.
• Utilise experience to identify and mitigate for study risks and help study team develop contingencies and to be closely involved in issue resolution and bringing studies back to plan, where appropriate.
• Accountable for financial management of assigned clinical studies and related activities within budget and to expected quality in accordance with Barinthus Bio best practice and policy.
• Support the Clinical Operations department and wider organisation in the evolution and/or development of systems, processes and procedures to support company growth and progression.
• Line and/or matrix management of clinical team staff (eg. Clinical Study Managers and/or Clinical Trial Administrators) and mentorship of staff.

KEY RESPONSIBILITIES INCLUDE:

• Input into setting of Clinical Programme goals in line with corporate strategy/goals
• Direct, plan, manage and drive clinical studies within assigned programmes from concept, feasibility, synopsis and protocol development, CRO and vendor selection through to execution including key milestones, focusing on time, cost, risk & quality and corporate objectives
• Accountability for:
• Financial management of clinical studies
• Sponsor oversight (ensuring plans are put in place and implemented and proof of oversight documented appropriately)
• Delivery of clinical documents, including but not limited to
• Study Synopsis
• Study Protocol
• Investigator Brochure
• Patient facing materials (eg. Informed consent form, adverts)
• ical Operations insight into programme strategy
• Clinical Operations input into Programme and related meetings
• Risk management of clinical studies
• Lead activities to develop Clinical Development Plans for assigned programmes and provide clinical operations input
• Represent the Clinical Operations department on behalf of Barinthus Bio, as and when required, when dealing with external stakeholders and partners
• Partner with Programme Lead to ensure studies are adequately resourced; consider internal and external options, monitor variances & analyse impacts, formulate options, develop contingency plans etc
• Provide accurate and complete clinical study information, including regular updates as required. Ensure related systems are maintained and information is accurate
• Support the set-up and attend scientific advisory board meetings to support clinical development strategy.
• Timely preparation of high-quality documentation for programme reviews and/or regulatory interactions.
• Contribute to design, development, improvement or redesign of Barinthus Bio corporate processes and especially those associated with Clinical Operations
• Act as back-up for, and provide support to, clinical study team

Financial:

• Accountable for clinical study budgets, minimising variance, reporting on any deviations and exceptions and managing scope change

Risk:

• Ensures Study level Risk Logs are in place for assigned clinical studies
• Works with study teams to ensure identification and management of critical to quality factors, key risk indicators and quality tolerance limits
• Supports ongoing risk identification, mitigation and contingency planning activities to ensure occurrence and impact of issues are minimised
• Supports Programme Lead with identifying programme level risks and maintenance of Programme level Risk Log

Quality:

• Accountability for clinical quality plans including internal and external audits
• Works within clinical study teams to establish quality plans across all studies
• Responsible for coordinating responses to audits/inspections of respective studies and/or related systems

Management

• Line management of assigned Clinical Operations team members and mentorship of staff members where appropriate

QUALIFICATIONS AND/OR EXPERIENCE REQUIRED TO PERFORM THE ROLE

• Undergraduate Science or Nursing Degree (or equivalent) with a minimum of 10 years Clinical Development / Operational experience in the pharmaceutical or biotechnology field
• Postgraduate qualification an advantage
• Clinical Study leadership experience reflecting a track record of study and/or programme delivery generating significant value to an organisation in the pharmaceutical or biotechnology field
• Demonstration of a comprehensive understanding of virology, vaccine or biologic development of oncology products would be an advantage
• Clinical Operations experience of early-stage (Phase 1/2) clinical trials will be an advantage