Associate Director, Clinical Development - Orchard

Reporting to: Senior Medical Director, 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.

This is a unique opportunity to join an agile and progressive team who are working to develop innovative therapies.

The position will suit a dynamic and experienced clinical development professional who has demonstrated success in working in a matrix team and is 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.

• Key team member, leading and ensuring development, review, finalization and delivery of high-quality key study documents in order to meet study timelines
• Maintains close communication and collaboration with clinical sites and physicians, gaining insight into study design, identifying, and leading solutions for study issues
• Strategic writing and review of regulatory documents and regulatory interactions (IND review, CTA submissions, BLA information requests)
• Acts as the medical monitor for one or more programs, overseeing CRO medical monitoring, and providing medical input and expertise
• Works cross-functionally to maintain critical overview of study related activities including labs/imaging/analysis, AE/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
• Where required, leads and contributes to preparation and strategic writing of regulatory documents related to the area of work (Scientific advice, IND submission, information requests, advisory meetings, BLA submission and associated FDA interactions, CTA submission), working closely with the clinical science and regulatory leads for the program(s) and wider teams
• Where required, develop a focused clinical study protocol that meets scientific objectives and can be implemented in the regulatory environment of all participating regions to provide quality data and ensure timely study delivery. Depending on the asset, this can be FIH, proof of concept, pivotal, or post registrational follow up studies
• Where relevant, 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
• Follows CMC/Manufacturing and other program-level activities and assesses changes and issues from clinical impact point of view. Ensures appropriate strategy is implemented and managed.
• Ensures accurate maintenance and archiving of study records
• Ensures efficient use of resources and adherence to strategic initiatives
• Contributes to the development and maintenance of the budget for associated assets/activities, ensuring cost effectiveness and addressing and escalating issues as appropriate. Manage vendors adeptly
• Considers entire lifecycle of product and cross functional impacts of key decisions and emerging issues, ensuring appropriate strategy is implemented and managed
• Develops clinical development project plans, manages risk, monitors progress, and implements contingencies as required
• Ensures adherence to Good Clinical Practice and all applicable local and international regulations. Accountable for timely delivery of scientifically and operationally robust study documents
• Plans and participates in publication plans and execution, as required
• Participates in business development initiatives for new programs, as required
• Presentation at internal and external meetings, congresses, symposia, board meetings, investor interactions, as required
• May be involved in supporting the hiring of new people and in shaping the company

This position may require 10% of time travelling

Requirements

• This role is best suited to an experienced clinical development professional who has demonstrated success in working in a matrix team, with external vendors and leading clinical development activities
• Understanding of regulatory environment, GCP/ICH, experience dealing with main global regulatory agencies, ideally an individual who has gone through a regulatory file process
• Robust understanding of all aspects of clinical development with previous experience in a similar position
• Previous IND/BLA/CTA/MAA/regulatory interaction experience desired
• Experience working with complex clinical development programs
• Gene therapy/paediatrics/neurometabolic diseases/neurology background desired, but not essential

• Mature thinker, capable of working independently and making decisions, as well as recommendations to a management team
• Awareness of when and how to escalate topics for senior input when needed
• A high achiever who can work in a fast-paced and highly dynamic environment
• Strategic mindset and the ability to quickly adjust according to changing demands
• Strong verbal, written and presentation skills
• 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
• Accountable and responsible individual
• 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 organizational skills: the ideal candidate will be able to prioritize activities depending on business imperative and to contribute to multiple projects in parallel
• Strong communication and presentation skills (including PowerPoint proficiency), enabling efficient sharing of information in external, internal, group, and 1:1 setting
• English fluency required
• ‘Can-do’ attitude and willingness to be flexible at short notice
• Able to work in a virtual enterprise
• Able to manage complex data and analyses
• Able to manage/collaborate with a group of world leading experts

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

We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify