Clinical Development Leader gMG

2 weeks ago

Chicago, United States argenx Full time

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The Clinical Development Leader gMG is responsible for the clinical development of all argenx assets intended to be developed in gMG. This includes strategic input in the different Target Product Profiles (TPP), Clinical Development Plans (CDP) and regulatory documents. Works in close collaboration with other leaders of the organization, in order 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 Doctors overseeing all medical aspects of the clinical programs of all compounds developed for gMG, thus maximizing both expertise and resource efficiency. The position reports into the Disease Area Lead Neuromuscular.

Roles and Responsibilities:

  • Medical point of contact for senior management and business development for gMG. This may include due diligences

  • Senior medical expert point of contact for all internal and external stakeholders in gMG

  • Oversee and guide the strategic medical input, execution, as well as interpretation of the clinical programs across all assets in gMG

  • Lead, coach and structure a group of highly qualified medical doctors across assets

  • Responsible for overseeing the successful registration of the different compounds in the indication, either as single product or in combination. This includes expert advice into the different study and regulatory documents coming from the team(s) under his/her supervision

  • Responsible for harmonization of practices and increasing efficiencies across the indication while remaining sensitive to overall harmonization/efficiency needs in the company

  • Ensure compliance for all medical aspects by understanding and applying all relevant SOPs and GCP

  • Closely collaborate with other functional leaders in order for medical vision, risks, issues, and results to be aligned with and clear to all involved parties

Desired Education, Experience and Qualifications:

  • Medical Doctor with Neurology certification or strong background in neurology clinical development preferred

  • Industry experience for at least 8-10 years

  • In depth knowledge of the indication, as well as its competitive and worldwide regulatory environment

  • Preferably has an established network of global KOLS

  • Excellent English, both written and spoken is a must, as well as ability to travel regularly

  • Proven interpersonal skills enabling him/her to work in teams, including other medical doctors, as well as commercial team members, while recognizing individual expert competencies, providing medical advice and evaluations

  • Pro-active problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organization

  • Strong communication skills to ensure close collaboration with the cross-functional leaders so that risks, issues, and results are made transparent all relevant parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and actions

#LI-Remote

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.

PDN-9d7fd961-14a6-4f6b-8ff2-8b21bf693f44

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