Argenxis seeking a dynamic clinical development leaderforMG program.MG isalarge, dynamic,and business criticalindicationin the company.
The ClinicalDevelopment Leader-MGis responsible forthestrategicclinical development of allargenxassetsindevelopmentforMGandincludesnext generationFcRnmoleculesanddrug combinations. This includes strategic input in the different Target Product Profiles (TPP), Clinical Development Plans (CDP), and regulatory documents.
The MG Lead works in close collaboration with other leaders of the organization to provide high quality clinical development that can reliably be executed within time and budget, and lead to successful registrations. He/she will oversee a group of Medical Doctorsinvolved in executing themedical aspects of the clinical programs, thus maximizing bothexpertiseand resource efficiency.
The ideal candidate will havesignificant experiencein clinical development for neurologic disorders, an innovation mindset, and a proventrack recordin drug development.The role requires embodying and championingargenx'sentrepreneurial spirit and core culture values, promoting innovation, collaboration, and accountability in cross-functional teams.
This is a hybrid role and will have frequenttravel.Europe orUnited States (EST time zone)based candidates are stronglypreferred.
The position reports into the Disease Area Lead-Neuromuscular.
Roles and Responsibilities:
1. Provide continuous strategic medical insight and planning for theindicationduring all the stages of developmentandlifecycle management
2. Own and lead theclinical development plan. Participate in long range strategic planning as dataemergein theindication
3. Work closely with senior managers and function heads,anticipatingneeds and ensuring clinical development excellence
4. Line management of the Global Clinical Trial Physicians working on theindication: coach and set example for their roles ensuring high quality medical support for the study teams,identifyhigh performers for potential other roles
5. Real time oversight of the medical aspects of studies in theindicationincluding the relevant communication to management as well as the different study teams
6. Safeguard harmonization across the studies so that communications to external stakeholders (e.g.questions of IRBs, RAs) are consistent and company efficiency ismaintainedin close collaboration with peers as well as management of the different functional groups
7. Leadindicationmedical ad boards as appropriate
8. Build and sustain a top-tier clinical development physician team
9. Ensure compliance of all studies in theindication
Education, Experience and Qualifications:
10. Medical Doctor;neurology specialty training strongly preferred havingacquiredin-depth understanding of, and experience in global drug development in neurology, including registration and commercialization process based on relevant experience of at least 7 years in the pharma/biotech industry.
11. Excellent English, both written and spoken isa must
12. Ability to travelglobally
13. Proven leadership, motivational and interpersonal skills in a global and intercultural environment,including direct line management and leading through influence, without having direct reporting lines
14. Pro-active problem solver with negotiation skills
15. Must provideclear vision, direction, and purpose toa network of empowered project teams
16. Demonstratedexpertisein clinical trial design,conductand interpretation of clinical data
17. Strong communicationskills to ensure that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requiresadditionalskills in gathering decision information, negotiation and communicating decisions and action
18. Executes his/her responsibilities with knowledge, accuracy, persistence,resilienceand creativity, being an accomplished team player whilstmaintainingmedical integrity
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For applicants in the United States: The annual base salary hiring range for this position is $296,000.00 - $407,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.