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Global Medical Affairs Director – Fibrosis

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Paris), the Netherlands (Leiden), Italy (Milan), Spain (Madrid), Switzerland (Basel), Germany (Munich), the UK (London) and in the US (Boston).

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.

We are looking for a Global Medical Affairs Director – Fibrosis to join the team. This role can be remotely based.

Scope of the job

  • As part of the Global Medical Affairs Team, you will focus on planning for a Global launch initially in Idiopathic Pulmonary Fibrosis, appropriately aligned with the global strategy.
  • The Global Medical Affairs manager/director role will focus on three main areasDevelopment of a pre-launch medical affairs plan, aligned with the global strategy and operational plans.Lead the stakeholder engagement activities partnering with key thought leaders, patient and professional organisations.Lead the implementation of Early Access and/or Compassionate Use programmes ensuring ethical and legal compliance.
  • Drive execution of specific medical projects.
  • Provide integrated scientific, clinical and product expertise within the therapeutic areas of fibrosis
  • Provide Medical review to European promotional and non-promotional materials.
  • Your role

    As part of the global fibrosis medical affairs team, the Medical Affairs Manager/Director will focus on the pre-launch preparation of Galapagos molecules for fibrosis indications, initially for Idiopathic Pulmonary Fibrosis (IPF). There are three key aspects to this role:

    Preparation of the pre-launch Operational Plan for IPF (and future indications as necessary)

  • Understand the patient pathway in key countries
  • Development and implementation of, alongside the Marketing Director, a Global focussed pre-launch plan in IPF, includingPlanning, designing and managing medical Advisory Boards.Implementation of the Globally focussed medical education/disease awareness activities, Investigator sponsored studies, and congress activities.Support Global, regional and country specific evidence generation and dissemination needs
  • Serve as a disease area and product area expert and maintain a high level of expertise
  • Support local affiliates as necessary, develop and facilitate internal and external training especially as a product expert
  • Develop and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and internal policies related to all medical activities, conducting and lead on medical review and approval of promotional and meeting materials.
  • Interaction with external stakeholders in alignment with customer needs and medical strategy

  • Act as a company representative with external stake holders.
  • Per medical strategy, produce an external stakeholder engagement plan that aims to:map stakeholdersestablish and/or enhance partnerships with key academic institutions and develop relationships with key thought leadersestablish appropriate partnerships with external experts, patient and professional associations, in areas of scientific interest
  • Represent Medical Affairs at internal and external meetings
  • Present data on product / therapeutic area
  • Lead implementation of Early Access Programmes or Compassionate Use Activities for any fibrosis indications

  • Develop an understanding of the needs, rules and compliance requirements for implantation of Early Access or Compassionate use programme Globally.
  • Lead the rollout, alongside a specialist support agency, of any such programmes, ensuring compliance with ethical and legal standards
  • Requirements

    Education and Experience Requirements

  • A medical degree or scientific degree (MSc, PhD or Pharm D)
  • Minimum 5-7 years of experience in biopharmaceutical medicine, with 3 or more pan-European or international experience
  • Experience of pre-launch operational planning and execution
  • Experience in field-based roles (e.g. Field Medical Director, Medical Science Liaison) is preferred as this role will require travel across Europe and interactions with key thought leaders, professional and patient organisations
  • Experience in leading cross functional projects
  • Experience of working in rare diseases or fibrosis is an advantage
  • Key Skills, Abilities, and Competencies

  • Demonstrated business acumen and operational skills
  • Demonstrated ability to work independently in pathfinder activities
  • Demonstrated capability to take on projects and execute flawlessly, results driven and accountable
  • Ability to work in a regional environment, across diverse cultures
  • Ability to collaborate appropriately with Commercial functions
  • Ability to represent company’s interest or present data in scientific forums as needed
  • Excellent written and verbal communication skills, English fluency is a must, other European languages is desirable
  • Good analytical skills as applied to medical, scientific and technical information
  • Unquestioned ethics are a must .
  • Other

  • Must be able to travel across Europe
  • Who are you?

    We are looking for a new colleague in our global medical affairs department with a solid medical/scientific background and experience in rare diseases and/or fibrosis. A genuine interest to advance science and healthcare in these areas to ultimately meet patient’s needs is mandatory. You are analytical to optimize data interpretation but also well capable to present data in a clear way both in writing as well as verbally and tailored to your audience. You are a team player with an open mind set who “dares to try” and can easily shift gears as needed. You are comfortable in pathfinder activities, creating European focused medical plans as well as initiatives and implementing those is something you enjoy and can be accountable for. When working with partners you are able to clearly represent the medical department of our company. You are honest and firm when it comes down to scientific and clinical data and will always keep in mind what it means for a patient with everything you do.

    What’s in it for you?

    You will be part of a fast-growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos, we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

    We are Galapagos: together we can make it happen…!

    Global Medical Affairs Director – Fibrosis

    Galapagos, Mechelen
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