ABOUT US

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

THE ROLE

We are looking for a Director Laboratory Services to join our Laboratory Services Department where you will lead all aspects of the Laboratory Services Department, to ensure that Laboratory Services are delivered to meet regulatory and clients’ development needs. You will be responsible for recruiting the best possible people, ensuring that they use their skills, knowledge and expertise to deliver on projects; the team works with excellence; and that the team grows and develops.

KEY ACCOUNTABILITIES

• Take strategic, operational and P&L responsibility for the Laboratory Services Department.
• Manage the hiring, development, coaching, mentoring, performance management and succession planning of employees to ensure current and future studies are resourced appropriately.
• Ensure all aspects of Laboratory Services (including assay development and validation and sample analysis / reporting) are in accordance with Simbec-Orion’s Quality Management System and appropriate regulatory requirements (including ICH-GCP, GCP for Labs, EMA, FDA); to ensure delivery in line with trial requirements and best scientific practice.
• Ensure Standard Operating Procedures are fully compliant with appropriate regulatory requirements and necessary accreditations (MHRA, ISO, UKAS and others as appropriate).
• Collaborate and consult with others, to develop and maintain strong working relationships with peers, senior leaders, key stakeholders ensuring cross-functional team-work to ensure projects are delivered on schedule and within budget.
• Participate in the Commercial Development activities (including Proposal and Budget reviews) and to lead and represent the Laboratory Services function in key client meetings including Bid Defence Meetings.
• Make recommendations to the Senior Leadership Team for the investment in, and growth of and change in the laboratories as time progresses.
• Ensure continuing professional development to enable the laboratories to be considered a Centre of Excellence and maintain a competitive position in the global marketplace.

SKILLS REQUIRED

ESSENTIAL

• BSc degree in a relevant discipline.
• Operational experience in either a Pathology (clinical) or Bioanalytical (chemistry) laboratory, resulting in strong working knowledge and confidence in laboratory best practice.
• Thorough working knowledge of GCP and GCP for Laboratories
• Extensive experience of Laboratory management including compliance with GXP and involvement in associated regulatory inspections; experience and understanding of relevant certification / accreditation (e.g. ISO) and external quality assessment schemes.
• Previous experience of leadership of a team of experienced and highly qualified individuals with varying needs/ambitions for development.
• Experience of managing a departmental budget.
• Good understanding of financial project management, including revenue recognition and Out of Scopes.
• Significant experience in commercial development activities including materially contributing to proposal/budget development and bid-defence meetings.
• Excellent verbal and written skills, with ability to tailor communication to a variety of internal and external stakeholders.

DESIRABLE

• MSc or PhD in a relevant discipline.
• HCPC registered Biomedical Scientist.
• Experience of maintaining laboratory regulatory compliance to FDA standards.
• Experience of obtaining / or heavy involvement in maintaining Laboratory accreditation ISO/IEC17025:2017 ‘General requirements for the competence of testing and calibration laboratories’ (or similar)
• Operational experience in both a Pathology (clinical) and Bioanalytical (chemistry) laboratory working on clinical study samples.
• Direct experience of developing and validating assays for use in the analysis of clinical study samples.
• Experience of working within a laboratory developing, validating and measuring biomarkers in clinical studies.
• Working knowledge of GLP.
• Good understanding of MHRA Phase I Accreditation scheme requirements.
• Working knowledge of Laboratory testing in a GMP environment.

WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.