Senior Medical Director Clinical Development

Location
United Kingdom
Posted
Aug 27, 2020
Ref
03E1B3BA8C
Required Education
Doctorate/PHD/MD
Position Type
Full time
Orchard Therapeutics Limited is a global biotechnology company headquatered in London, UK and dedicated to bringing transformative gene therapies to children and adults with severe and life-threatening orphan diseases. The company has been founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.

Orchard's ambition is to be recognized a global leader in the development and commercialization of transformative gene therapy medicines for patients with severe and life-threatening orphan diseases.

Orchard's Leadership team and collaborators have more than a decade of experience in the development, manufacturing and commercialization of advanced therapies for rare diseases. We work in partnership with the world's most prestigious research centres to harness the life-giving potential of gene therapy.

Our mission is to provide the ideal environment and expertise to translate promising pre-clinical and early clinical results into commercially approved medicines available to patients around the world.

Our programmes leverage the potential of pioneering gene therapy technologies to restore normal gene function in patients with primary immune deficiencies and metabolic diseases. Indications currently under investigation include primary immune deficiencies, hematologic and metabolic disorders.

Our aim is to bring transformative gene therapies to patients with life-threatening / changing orphan diseases: we ultimately serve the interests of patients and their families;

We provide an entrepreneurial and dynamic work environment;

We are performance-driven and reward individuals accordingly.

Job summary
Reporting to the VP Immunology and Heamatology, the position will be, accountable for medical management for the development of one or more assets in the pipeline, from early trough late development/registration and comercialization, working in partnership with the cross functional study teams. This person will be involved inthe strategy for clinical development, the clinical development plans, managing the clinical studies, the regulatory documentations/presentations, writing and executing regulatory interactions together with the clinical team for key advisiory meetings, Pre IND meetings, FTIH, End of Phase II meeting, pre NDA, etc.
The selected individual will be collaborating with other departments with a project focus mentality.

The role will have cross functional interactions with the following departments:

  • Project Leadership
  • Biostatistics
  • Clinical Operations
  • Pre-Clinical
  • Medical Affairs
  • Pharmacovigilance
  • Technical Operations
  • Regulatory

Requirements

Key Elements and Responsibilities
  • Responsible as Medical leader for input into the clinical programmes in the franchise.
  • 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 study related activities such as 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 Medical input, review, finalization and delivery of high quality key study documents in order to meet study timelines.
  • Ensures accurate maintenance and archiving of study records
  • Leads/Helps to prepare and submit regulatory documents related to the area of work (Scientific advice applications, pre INDs, FTIH, advisory meetings, etc). Participates in regulatory meetings.
  • Helps to assess and works closely with CMC/Manufacturing needs/activities. Ensures appropriate strategy is implemented and managed.
  • Input into project plans, manages risk, monitors progress, and implements contingencies as required.
  • Ensures adherence to Good Clinical Practice and all applicable local and international regulations.
  • Helps with SOPs, study procedures, etc
  • Works closely with the Medicalexperts ensuring the right data is being generated for the programmes in development (assay validation, right endpoints, endopint validation, study design, comparator arms, etc)
  • Plans and participates in publication plans and execution, presentation in meetings, congresses, etc
  • Assess signal detection, early safety signals with the pharmacovigilance team
  • Participates in planning with medical affairs activities and may represents the organization in congresses, patient advocacy groups, etc
  • Work closely with the commercial team working on reimbursement plans, access, etc
  • Work together with the CMO on presentation/communications
  • Be part of the matrix team for the programme/study specific activities
  • Helps hiring new people and in shaping Orchard's Clinical/operational team, as the company grows
  • Able to act as deputy of CMO when required or in specifics settings/tasks
  • 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

Required knowledge
  • Gene therapy/immunology/haematology-oncology background
  • Experience in being part of Matrix team
  • At least 2 years experience in similar position
  • Understanding of regulatory environment, GCP/ICH and GMP, experience dealing with regulatory agencies
  • Robust understanding of all aspects of clinical development
  • Experience working with complex programmes, ideally experience in Gene/cell Therapy programmes

Skills & Abilities
  • Mature individual, capable to work independently and make decisions/recommendations
  • Accountable and responsible individual
  • Collaborative working style; the ideal candidate will partner effectively with his colleagues across the organization to seek critical information, constructively challenge plans
  • Strategic mindest
  • Excellent organisational skills; the ideal candidate will be able to prioritize activities depending on business imperative and to contribute to several projects in parallel
  • Outstanding presentation skills (Excel, Powerpoint)
  • 'Can-do' attitude and willingness to be flexible, lift work (even when below his/her rank)
  • Able to manage complex data
  • Able to work in a pressurized environment
  • Able to manage/collaborate with a group of world leader experts
  • First rate academic background, educated to MD with a relevant post-graduate qualification
  • Ideally background in Gene therapy, Immunology, and or haematology
  • Ideally a Pharmaceutical Physician with MFPM or equivalent

Education

  • First rate academic background, educated to MD with a relevant post-graduate qualification
  • Ideally background in Gene therapy, Immunology, and or haematology
  • Ideally a Pharmaceutical Physician with MFPM or equivalent