Associate Director, Global Medical Affairs

Location
London, United Kingdom
Posted
May 27, 2021
Ref
F26CABFF56
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Global Medical Affairs

Location: London, UK

Reporting to: Senior Director, Global Medical Affairs

Job summary

The Associate Medical Director, Global Medical Affairs for Primary Immunodeficiencies will report to the head of the Global Medical Directors team and will be a key member of the Global Medical Affairs organization. This role will work in close collaboration with the R&D and commercial teams to shape and execute Global Medical Affairs strategies and plans for Orchard's immunodeficiencies programs in Wiskott-Aldrich Syndrome (WAS), Adenosine Deaminase Deficiency Severe Combined Immunodeficiency (ADA-SCID), and X-linked Chronic Granulomatous Disease (X-CGD).

The Associate Medical Director will work internally in partnership with the commercial team, market access, regulatory, pharmacovigilance, clinical development, and cross functional study teams, the program leaders, as well as with other teams in Medical Affairs including Medical Communications and the Regional Medical Affairs teams in the UK, Europe, and the US. They will also forge relationships with key external thought leaders in their therapeutic areas. This person will be key in driving the Global Medical Affairs strategy for both commercial and investigational immunodeficiency programs, helping drive development into the clinic with the Target Product Profile in Mind.

Key Elements and Responsibilities

  • Develop Global Medical Affairs strategic plan for immunodeficiency programs, in partnership with Senior Director of Global Medical Affairs
  • Lead team execution Global Medical affairs tactics for immunodeficiency programs globally, with focus on WAS and ADA-SCID, in collaboration with other Medical Affairs functions (Medical Communications, Field Medical, Medical Information, etc.)
  • Works together with medical communications to develop and implement publication and congress strategy, including leadership of medical symposium activities
  • Become internal subject matter expert for immunodeficiencies and technology including providing training and serving as internal consultant on cross-functional projects
  • Present at internal and external meetings, representing medical affairs, including at congreses and to patient advocacy groups
  • Works closely with experts to review data generated for publications and post marketing programs in development
  • Provides expertise as a member of internal team approving grants, research proposals
  • Work as a team with the other Medical Affairs functions, collaborating cross-functionally with R&D and commercial together with legal to develop global communication plan for internal and external stakeholders including board presentations and investor presentations
  • Collaborates cross functionally with commercial and other stakeholders to plan launch activities for the programs lined up for file/approval
  • Provides medical insight into label activities to support regulatory filings and approval commitments. Responsible for authoring of risk management materials in preparation for filing. Participates in regulatory meetings where required.
  • Supports market access team, health outcomes evidence generation, health technology assessments, written responses, and where necessary oral hearings
  • Leads gap analysis and oversights of data generation activities for responsible programs
  • Responsible as Medical leader for building KOL physician relationships and representing the company in key meetings, congresses
  • Build external relationships with patient advocacy groups related to immunodeficiency disorders; responsible together with patient relationship team for building the patient network, patient information and training activities
  • Works with clinical sciences and clinical operations to support development, review, finalisation and delivery of high quality key study documents in order to meet study timelines.
  • Working in partnership with the cross functional study team, develop phase 4 clinical studies/programs/registries ensuring the development, review, finalisation and delivery of scientifically and operationally robust study documents in order to meet study timelines
  • Collaborate with CMC/Manufacturing to help assess needs/activities for commercialisation
  • Supports site qualification engagements and activities for clinical sites and commercial treatment centres.
  • Drives SOPs related to the function together with QA
  • Responsible for maintaining Orchard Therapeutics' compliance with international code of practices
  • Review and approval of materials, including promotional and non promotional material.
  • Other responsibilities as assigned
  • Travel 25-40%


Requirements

Required knowledge
  • Gene therapy or cell therapy program experience is desirable
  • Experience working with complex programs, ideally in rare diseases
  • Experience in immunodeficiencies is desirable
  • Experience in previous MAA or BLA is desirable
  • Experience with commercial/reimbursement in rare diseases is desirable
  • Experience in leading a matrix team
  • Excellent organizational skills; ability to prioritise activities depending on business imperative and to contibute to several projects in parallel
  • Ability to manage complex data
  • Ability to manage/collaborate with a group of world leading experts
  • Advanced medical or scientific degree (MBBS/MD, MPharm/PharmD, PhD) required
  • Ideally ABPI/EFPIA signatory and conversant in international code of practices

Skills & Abilities

  • Thrives in a fast-paced/dynamic startup environment
  • 'Can-do' attitude willing to roll up sleeves as needed
  • Proactive working style
  • Strengths in problem solving and constructive thinking to achieve a complex task
  • Outstanding communication and presentation skills
  • Communicative and collaborative working syle; able to partner effectively with colleagues cross-functionally across the organisation

Education

  • Advanced medical or scientific degree (MBBS/MD, MPharm/PharmD, PhD) required
  • Ideally ABPI/EFPIA signatory and conversant in international code of practices