JOB DESCRIPTION

Department: Translational, Regulatory Affairs and Clinical (TRAC)

Reports to: Senior Director of Translational Bioanalytics

Direct Reports: 3 (1 current, 2 new positions)

MAIN PURPOSE OF JOB

As a Group Leader, you will be a member of the Translational Bioanalytics team within the Translational, Regulatory Affairs and Clinical department at Evox. The Group Leader will support the characterisation of Evox’s exosome-based delivery platform technology and the advancement of therapeutic pipeline programs.

You will play a key role in leading the development and execution of biomarker and bioanalytical strategies across projects. You and your team will be responsible for the development, validation and execution of PK, PD and immunogenicity assays in support of analysis of preclinical and clinical samples, and interpretation of data. You will also provide immunology subject matter expertise to help build understanding of immunological response or tolerance to our exosome-based therapies. As required, you will also provide scientific support in design and implementation of internal and external preclinical pharmacology studies, and may be translational medicine lead on projects, or have the opportunity to be project lead.

KEY ACCOUNTABILITIES

• Grow and lead the bioanalytical and biomarker assay team, manage performance and personal development, set and review objectives, training, operational and resource planning
• Provide leadership and oversee internal and external development of biomarker and bioanalytical assays (i.e. PK, PD and immunogenicity) needed to support preclinical and clinical studies; this includes the transfer and validation of assays externally as required
• Provide subject matter expert input to in vivo pharmacology study planning, lead design and execution of sample analysis phase, responsible for analysis and interpretation of data, and reporting of findings to project teams
• Drive immunogenicity assessment studies to support characterisation of platform technologies and of pipeline candidates
• Act as point of contact for external bioanalytical laboratories
• Represent the Translational function in one or more platform and pipeline project teams, contribute to project strategy, plans, decision making and ensure integration of development plans
• Responsible for compliance, maintaining rigorous standards and accurate reporting of studies
• Role model the Company values and leadership behaviours, cultivating high performing and highly engaged teams and work collaboratively across functions and departments
• Build strong working relationships with enabling functions, including Finance and Facilities
• Build relationships with vendors and contractors

PERSON SPECIFICATION

• Highly motivated individual who enjoys working collaboratively across functions
• Ability to work independently and in a high-paced team environment, setting priorities for work from multiple projects to deliver objectives
• Organised with strong attention to detail
• Clear written and verbal communications skills with the ability to clearly convey processes, results and key messages and able to build strong relationships with colleagues and external partners

Experience & knowledge

• PhD in a relevant subject with industry experience in development of biologics, RNA and/or gene therapies
• Strong knowledge and experience in development and execution of PK, PD and anti-drug antibody assays needed to support early discovery, regulated preclinical and/or clinical studies
• Experience in designing and implementing experimental approaches to monitor immune responses
• Working knowledge of bioanalytical method validation regulatory guidance for biologics and/or gene therapies
• Experience overseeing and reviewing external studies
• Knowledge and experience drafting and submitting documents needed for CTA/IND submission
• Experience of compiling data, writing reports and providing recommendations to project teams
• Experience analysing, interpreting, and presenting complex scientific data
• Line-management experience

KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF

People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.

Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.

Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.

Candid and Constructive – We communicate with honesty and transparency throughout the team. We value giving and receiving constructive feedback to each other and our partners.