Location: London, UK

Reporting to: Vice President, Clinical Development

Job Summary

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and its U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

The Medical Director, Clinical Development, will play a pivotal role in shaping and driving one or more of Orchard’s clinical development programs. As the clinical development lead, they will be responsible for developing and executing clinical strategies that align with the company’s scientific and regulatory goals. They will also have the important responsibility of serving as the clinical lead in regulatory interactions across all phases of development, from early clinical trials to regulatory approval and ongoing post-marketing commitments.

This is a unique opportunity to join a dynamic, forward-thinking team committed to advancing innovative therapies that have the potential to transform patient lives. The position will suit an agile and experienced clinical development professional who has demonstrated success in working in a matrix team, looking for an opportunity to join a collaborative team, where they can apply their curious, problem-solving mindset in a fast-paced, high-impact environment.

RESPONSIBILITIES

- Accountability for integrated clinical development strategy planning for one or more Orchard programs.

- Develop and execute robust clinical plans that meet scientific objectives, align with regulatory requirements across all participating regions, and deliver high-quality data for timely asset delivery.

- Representation of clinical development on a cross-functional program strategy team

- Chairing of the asset clinical strategy team

- Leading and ensuring development, review, finalization and delivery of high-quality key clinical study documents, including SOPs and other compliance documents, where required, to meet study timelines.

- Clinical lead for regulatory interactions – both written and verbal (meetings).

- Leadership of the strategic writing and review of clinical sections of regulatory documents and regulatory interactions (IND review, CTA submissions, BLA information requests)

- Acts as the medical monitor for one of more programs, overseeing CRO medical monitoring, and providing medical input and expertise, including collaboration with pharmacovigilance.

- Works cross-functionally to maintain critical overview of study related activities including SAE/stopping criteria, signal detection, data management/stats analysis, etc; as well as planning investigators meetings, kick off meetings, and similar forums for study activities discussions

- Leads clinical considerations for entire lifecycle of product and cross functional impacts of key decisions and emerging issues, ensuring appropriate strategy is implemented and managed

- Development and maintenance of the clinical sciences budget for associated assets/activities, ensuring cost effectiveness and addressing and escalating issues as appropriate. Manages vendors adeptly.

- Plans and participates in publication plans and execution, as required

- Develops clinical development project plans, manages risk, monitors progress, and implements contingencies as required. Ensures efficient use of resources and adherence to strategic initiatives

- Ensures adherence to Good Clinical Practice and all applicable local and international regulations.

- Participates in business development initiatives for new programmes, as required

- When required, ensures preclinical data is adequate for the FIH study start, in collaboration with the early development leader, Head of Preclinical and CSO, to make the transition from pre-clinical to clinical development

- Presentation at internal and external meetings, congresses, symposia, ELT meetings, board meetings, as required

Experience

- Robust understanding of all aspects of Clinical Development with previous experience successfully leading complex Clinical Development programmes in a matrix team.

- Proven experience collaborating with external partners, including investigators, academic partners, and vendors.

- Strong understanding of regulatory environment, GCP/ICH

- Demonstrated expertise in leading regulatory interactions with global regulatory agencies (FDA/EMA/MHRA/PMDA), ideally with experience of leading a regulatory file process (BLA/MAA)

- Gene therapy/paediatrics/neurometabolic diseases/neurology background strongly desired.

- Significant prior experience of working in biotech/pharma or regulatory agency essential.

Skills

- Mature thinker, who takes accountability and is capable of working independently to make robust decisions, as well as recommendations to a management team.

- Awareness of when and how to escalate topics for senior input when needed

- Strong communication (written and verbal) and presentation skills (including PowerPoint proficiency), enabling efficient sharing of information in external, internal, group, and 1:1 setting.

- Proven ability to prepare and deliver confident presentations to external parties, including regulatory agencies, responding to questions in real time with clarity and composure.

- Ability to connect peer to peer with world leading experts.

- Ability to work in a fast-paced and highly dynamic environment. ‘Can-do’ attitude and willingness to be flexible at short notice

- Strategic mindset and the ability to quickly adjust according to changing demands

- Proactivity – pragmatic identification of issues, taking ownership of routes to solution without prompting

- Strong leadership skills – able to lead workstreams and influence across cross functional teams

- Collaborative working style; the ideal candidate will partner effectively with their colleagues across the organization to seek critical information, constructively challenge plans and assist with the optimal allocation of resources

- Excellent organisational skills: able to prioritize activities depending on business imperative and to contribute to multiple projects in parallel

- Able to work and navigate the complexities of academic/biotech interface

- Able to work in a virtual enterprise

- Able to manage complex data and analyses

Education

- Medical degree essential, with at least 4 years of clinical work following qualification. Ideally with a relevant post-graduate qualification (e.g., MRCP, MRCS, MFPM, MD, PhD)

- DipPharmMed or equivalent desirable