Role Summary
The Global Indication Lead provides expert medical leadership to guide development, launch planning, life cycle management and support for approved products, as relevant for the indications stage of development. Works with cross-functional colleagues as a key member of the Indication Development Team to input to the target product profile, clinical development plans and pre-launch strategy, and brand plans ensuring regional Medical Affairs insights inform all stages of development.
Responsibilities
- Provide expert medical input to guide clinical development, comprehensive evidence generation, launch planning and brand plan execution in relevant indications
- Develop and execute ambitious short-term and long-term medical strategies, as key elements of the integrated data generation plan and brand plan
- Accountable for the alignment of all global medical affairs activities in partnership with other cross-functional members of the Indication Development Team
- Develop close partnerships with regional and country medical affairs leads/teams, and the regional indication strategy teams and ensure all activities maximise cross-regional impact whilst enabling regional team empowerment and supporting local delivery
- Build and maintain close partnership with external experts, in collaboration with regional/country Medical Affairs teams, to bring insight to all activities
- Initiate and support high impact medical activities, such as advisory boards, congress symposia and medical research projects
- Drive the identification and development of productive collaborations including with healthcare organisations and experts, other important customers and stakeholders and professional organizations
- Support strategy development for investigator sponsored studies and assessment of proposals
- Partner with scientific communications to support development of publication and medical education strategies
- Develop and continuously maintain the highest scientific and medical expertise with relevant diseases and products and be acknowledged internally and externally as an expert
- Systematically capture, distil and proactively communicate insights and activities within argenx
- Ensure all medical affairs activities maintain the highest standards, comply with applicable pharmaceutical regulations, as well as argenx policies and procedures
Skills
- Able to quickly understand complex disease areas, treatments and development and brand strategies
- Proven track record of building productive collaborations with external medical experts and networks and to gain actionable insights
- Understands how to build internal cross-functional and cross-regional collaborations, ensuring broad input to decision making
- Embraces innovation and shared goals
- Has excellent communication skills: verbal, written and when giving presentations
- Has strong influencing skills to be able to engage effectively with internal and external stakeholders
- Able to thrive as part of a team and when working independently
- Proven track record of delivering results that meet or exceed targeted objectives
- Fluency in English, in addition to the local language(s), both oral and written
Education
- Scientific, healthcare or medical degree (BSc, MS, PhD, PharmD, RN, MBBS, MB.ChB or equivalent).
- Substantial medical affairs experience, throughout the product lifecycle
- A strong understanding of the drug development process and launch planning
- Relevant drug development, therapeutic area expertise and existing external expert network is an advantage
- Robust knowledge of regulations and practices related to industry interactions with healthcare professionals
- Experience partnering with regional/country and global functions and leadership