Director Clinical Development

Location
London, United Kingdom
Posted
Jun 07, 2021
Ref
713CB73D23
Required Education
Bachelors Degree
Position Type
Full time
Director Clinical Development

Location: London, UK

Reporting to: Senior Director, Clinical Development

Job Summary

The Director, Clinical Development will be responsible for the strategy and implementation of one or more of the programmes in the franchise and for the development of the clinical programmes in the program/s for the franchise. For the leading program, this person will be the Program Leader and responsible for the day to day activities as well as the whole franchise activities.

Key Elements and Responsibilities
  • Works in collaboration with re R&D team to prepare board presentation, external presentations, investors presentations, funding rounds, etc
  • Responsible for budgeting and tracking budget for all the programmes in the II&H pipeline
  • Ensures preclinical data is adequate for the FTIH study start, in collaboration with the early development leader, head of preclinical and CSO, to make the transition from pre clinical to clinical development
  • Manages all study related activities including labs/analysis, AE/SAE with Pharmacovigilance, data management/stats analysis, etc; as well as planning investigators meetings, kick off meetings, and similar forums for study activities discussions
  • In partnership with the cross functional study team develops 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.
  • Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
  • Ensures accurate maintenance and archiving of study records
  • Accountable for study execution, tracking and management of study delivery
  • Leads/Helps to prepare and submit regulatory documents related to the area of work (Scientific advice applications, pre INDs, FTIH, advisory meetings, etc). Participates/leads in regulatory meetings. Works closely with the Regulatory team to develop the strategy to present to management
  • Manages feasibility and determines study allocation to appropriate sites, CROs, ensuring efficient use of resources and adherence to strategic initiatives
  • Develops and maintains the global project budget, ensuring cost effectiveness and addressing and escalating issues as appropriate.
  • Manages CROs and vendors
  • Helps to assess and works closely with CMC/Manufacturing needs/activities. Ensures appropriate strategy is implemented and managed.
  • Develops project plan, 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.
  • Helps with SOPs, study procedures, etc
  • Works closely with the Consortium of experts ensuring the right data is being generated for the programmes in development (assay validation, right endpoints, endpoint validation, study design, comparator arms, etc)
  • Ensures continuous direct contact with in-country personnel/CROs to provide ongoing operational support. Accountable for programme related communications and for resolution or escalation of operational issues.
  • Develops program/study communication plan to ensure efficient and appropriate global communication to all internal and external stakeholders.
  • Plans and participates in publication plans and execution, presentation in meetings, congresses, etc
  • Assess signal detection, early safety signals with the medical team
  • Participates in planning/driving medical affairs activities together with the medical team, represents the organization in congresses, patient advocacy groups, etc
  • Works closely with the commercial team working on reimbursement plans, access, etc
  • Works together with the CMO and commercial/legal on presentation/communications
  • Manages the matrix team for the programme/study specific activities
  • Participates in business development initiatives for new programmes
  • Puts in place contracts, ensures maintenance of the specific programme database
  • Works closely with our CROs, External partners and Contractors/experts/help to select our vendors
  • Works closely with Manufacturing head to oversee and plan the CMC/Commercial plans
  • Represent the company in key meetings
  • Helps hiring new people and in shaping Orchard's Clinical/operational team, as the company grows
  • Able to work and navigate the complexities of academic/biotech interface, working integrated with the academic partners, keeping relationships, managing and integrating to the Orchard's structure the academics sites

This position will require 30% of time travelling

Requirements

Required Knowledge
  • Gene therapy/immunology/haematology-oncology background
  • Experience in Leading a Matrix team, vendors and Clinical development activities
  • previous experience in similar position
  • Managerial experience
  • Understanding of regulatory environment, GCP/ICH and GMP, experience dealing with regulatory agencies, ideally a person who has gone through a regulatory file process
  • Robust understanding of all aspects of clinical development
  • Experience working with complex programmes, ideally experience in Gene/cell Therapy programmes

Skills and Abilities
  • Mature individual, capable to work independently and make decisions/recommendations to a board/management team
  • Accountable and responsible individual
  • Collaborative working syle; the ideal candidate will partner effectively with his colleagues across the organization to seek critical information, constructively challenge plans and assist with the optimal allocation of resource
  • Strategic mindest
  • Excellent organisational skills; the ideal candidate will be able to prioritize activities depending on business imperative and to contibute to several projects in parallel
  • Outstanding presentation skills (Excel, Powerpoint)
  • First rate academic background, educated to degree level, ideally MD with a relevant post-graduate qualification
  • Ideally background in Gene therapy, Metabolic diseases, CNS, Immunology, and or haematology/oncology
  • 'Can-do' attitude and willingness to be flexible
  • Able to work in a virtual enterprise
  • Able to manage complex data
  • Able to work in a pressurized environment
  • Able to manage/collaborate with a group of world leader experts

Education
  • First rate academic background, educated to degree level, ideally MD with a relevant post-graduate qualification
  • Ideally background in Gene therapy, Metabolic diseases, CNS, Immunology, and or haematology/oncology