Full-time

Location: London/UK/Europe (Office/Remote), Boston/US (Office/Remote)

Reporting to: VP Clinical Development

Job Summary

Orchard Therapeutics, recently acquired by Kyowa Kirin, is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. Orchard has its global headquarters in London and headquarters in Boston.

The Director, Bioanalytical Diagnostic Development, will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical bioassays/diagnostics, from preparations for ‘first in human’ up to registrational studies and post-approval commitments. As a key member of the Clinical Development Team, they will ensure bioassay readiness requirements are achieved during study protocol design through to execution. The successful candidate will be a strategic thinker with a strong track record serving as a subject matter expert within a matrix organisation. They will have a crucial role in ensuring that diagnostic assays, including, where applicable, companion diagnostic (CDx), development, regulatory approval and commercialisation is planned and executed within Orchard’s internal asset development plan. They will be at the intersection of study lab vendor, CRO and the broader clinical team to provide key expertise in study specific, potentially specialist, bioassay set-up and implementation.

Requirements

Key elements and responsibilities

· Serve as the bioanalytical subject matter expert for Orchard assets.

· Build a bioanalytical strategy and global development plan for therapeutics at various stages of development (pre-clinical to post-marketing).

· Manage development, validation, and transfer of bioanalytical assays as required.

· Manage regulatory compliance of diagnostic development and associated bioanalytical laboratory operations, to support development activities, with good laboratory practices (GLP), OECD regulations, FDA, EMA, PMDA and other relevant global bioanalytical and immunogenicity guidance documents.

· Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.

· Partner with Clinical Science and Regulatory Science teams to provide subject matter expertise for diagnostic (and where applicable CDx development) for relevant asset(s).

· Partner with Clinical Operations team for lab vendor selection, contracting, and lab/sample/assay management.

· Review and approve method development and/or validation reports prepared by lab vendors.

· Perform data reviews to ensure assays are fit for purpose including data analysis and trouble-shooting.

· Conduct gap analysis and identify logistical constraints to sample collection, shipping, stability, processing, and provide proactive leadership of mitigation strategies and corrective actions.

· Ensure concordance for bioassays performed in more than one laboratory.

· Author clinical study protocol sections related to bioassays, reports and the bioassays sections of IND, IMPD, BLA/MAA, and other regulatory documents.

· Lead relevant SOP development and staff training.

· This role will require domestic and international travel (approx. 10%).

Knowledge & Experience

· Solid experience in pharmaceutical industry and/or CRO which has led to exposure to the overall lifecycle of therapeutic asset development.

· Experience in:

o the development, validation and sample testing of assays required for cell and gene therapy products

o working with analytical laboratories analysing research and clinical samples as part of laboratory routine work

o laboratory compliance/accreditation requirements ( CLIA, ISO 15189)

o global (US, EU, UK) LDT/IVD development

o assay transfer (ideally including academic to commercial partners).

· Awareness of bioanalytical guidelines particularly in the context of cell and gene therapy products ( FDA, EMA, MHRA).

· Experience in/management of development of assays for CDx use. Experience in supporting diagnostic development and regulatory submissions for diagnostic marketing approval.

· Proven experience working with complex matrices and cell isolation, ideally also exposure to technologies required for cell and gene therapy products such as NGS, PCR variations including ddPCR, flow cytometry.

· Proven track record in managing Central laboratory services and multiple laboratory providers (external vendors).

· Experience of bioassay/diagnostic gap analysis, corrective actions, and process improvements.

· Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies).

· Experience in preparing bioanalytical components of clinical study protocols and reports.

· Exposure to regulatory agency inspection.

· Career progression reflects successful performance.

Skills & Abilities

· Proven ability to develop strategic relationships with academic, biotech and clinical partners.

· Strong leadership, communication, mentorship and project management skills.

· Effective in engaging collaboratively and cross-functionally adopting a problem solving and non-linear thinking approach.

· Able to work independently and take initiative.

· Successful working in a matrix role, engaging closely with external partners and internal SMEs, with the ability to flex to both leadership and hands-on responsibilities.

· Proven to be successful in collaborating with multiple internal stakeholders, including clinical operations, clinical sciences, regulatory, diagnostics, analytics, quality, legal, program leadership.

· Challenges status quo to achieve continual improvement and strong quality culture, leading to efficient and effective ways of working.

· CRO Management.

· GxP regulation proficiency.

Education

· Masters degree in life science, cell and molecular biology, biochemistry or related field.

· PhD in the above fields would be idea