Director, Medical Affairs UK and Ireland

Location
London, United Kingdom
Posted
Jul 04, 2021
Ref
99ADB4AE63
Required Education
Bachelors Degree
Position Type
Full time
Location: UK

Reporting to: Head of Medical Affairs EMEA

Job summary

Reporting to the Head of Medical Affairs EMEA and working in close collaboration with the GM UK and Ireland, the position will be accountable for managing Medical Affairs for Orchard's gene therapy portfolio in the geography, with focus on Libmeldy and Strimvelis, providing support for pipeline programs including WAS, X-CGD, MPS-I and MPSIII. The Director Medical Affairs will be working in partnership with cross functional teams, the program teams and HCPs in the geography. This person will be key in driving the Medical Affairs strategy for our approved drugs and late stage programs as well as providing input to those in early stages, helping to drive development into the clinic.

Key Elements and Responsibilities
  • Responsible for the strategy and implementation of the Medical affairs activities for Libmeldy and Strimvelis in the UK and Ireland
  • Develops project plan, manages risk, monitors progress, and implements contingencies as required.
  • Ensures regular direct contact with GM UK and Ireland to provide ongoing operational support.
  • Becomes medical expert for the diseases and technology
  • In charge of internal training for the local commercial functions
  • Works in collaboration with the Medical Affairs team to prepare external presentations
  • Responsible for budgeting and tracking of local Medical activities
  • Managing and fostering the existing relationship with Qualified Treatment Centre and identifying potential future qualified treatment centres for pipeline programs
  • Lead the efforts on implementation of new-born screening programs in collaboration with Global Diagnostics
  • Supporting the local HTA processes in collaboration with Market Access and Commercial
  • Build Expert and physician relationships
  • Review of educational materials, training programs, etc.
  • Plans local medical launch activities for the programs in the pipeline for file/approval.
  • Maintain the local medical affairs project budget, ensuring cost effectiveness and addressing and escalating issues as appropriate.
  • Serves as ABPI signatory for promotional materials and other documents and assures local compliance with ABPI code of practice
  • Works closely with HCPs to identify publication opportunities and local data generation strategies with local KOLs
  • Driving medical affairs activities together with the medical team and the local commercial team, represents the organization in congresses, patient advocacy groups, etc.
  • Works closely with the local commercial team working on reimbursement plans, access, EAP/CUP, etc.
  • Represents the company in scientific meetings.

Requirements

Required Knowledge
  • This position will require approx.40% of time travelling
  • GMC-registered MD or Pharmacist
  • Gene therapy background preferable
  • Biotech background preferable
  • Experience in working in a complex Matrix team
  • Understanding of regulatory environment, GCP/ICH and GMP, experience dealling with regulatory agencies, ideally a person who has gone through a regulatory file process
  • Understanding of ABPI Code of Practice and able to serve as Medical Signatory for materials in the geography
  • Commercial/reibursement experience in rare diseases ideal
  • Experience working with complex programmes, ideally experience in Gene/Cell Therapy programes


Skills and Abilities
  • Experienced 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
  • 'Can-do' attitude and willingness to be flexible, lift work
  • Able to work in a virtual enterprise
  • Able to work in a fast-paced, dynamic environment
  • Able to manage/collaborate with a group of world leading experts


Education
  • GMC-registered MD or pharmacist with a relevant post-graduate qualification
  • Ideally background in gene therapy, rare disease, immunology,neurology or metabolic disease and/or haematology/oncology
  • Ideally a Pharmaceutical Physician with MFPM or equivalent


Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. 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.