Sr. Director RA Early Development Lead

argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. Our employees are self-disciplined, hardworking, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they are the cornerstone of argenx. For the  expansion of our regulatory team, argenx is looking for a  Senior Director to support the rapid growth needed for its pipeline.

Key Accountabilities and Responsibilities:

The person in this role is a key member of the global regulatory leadership team. This role is responsible for overseeing the implementation of global regulatory strategies for the successful delivery of development milestones through end of first in human studies. In addition to leading the Early Development Regulatory Team (EDRT), the individual will be a member of the cross-therapeutic Early Development Disease Area Committee which advises on the design and conduct of FIH and proof of concept studies for new programs.

Your primary areas of focus are:

Regulatory Strategy for  Early Development Programs

• Lead regulatory strategy considerations and interactions for early stage programs

• Collaborate with early development, asset and indication teams to align regulatory strategies with commercial and business objectives and develop integrated early development plans (IDP).

• In conjunction with the Global Head of Regulatory and the wider organization, this role will lead the development and implementation of infrastructure and process improvements to enhance the efficiency of the Global RA organization to enable significant expansion of its early stage pipeline.

• Monitor global regulatory trends and advise on best practice for entry into the clinic as well as developing initial regulatory strategies to enable regulatory licensure. .

• Collaborate with PMO/Reg PM staff to plan project timelines, and project resourcing requirements against the approved IDP and  to ensure regulatory strategies are aligned with broader organizational strategies

• Foster and mentor the members of the Early Development regulatory community

Stakeholder Engagement

• Build and maintain strong relationships with health authorities, external partners, and internal stakeholders to facilitate regulatory approvals.

• Represent the company in external forums, conferences, or regulatory working groups to stay informed of regulatory updates and share insights.

Regulatory Intelligence

• Collaborate with the regulatory intelligence team and organizationally with Regulatory Policy to continuously assess regulatory requirements and changes in global markets to anticipate challenges and mitigate risks.

Desired Skills and Experience:

• Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with experience of early development regulatory strategies and submissions

• PhD or PharmD preferred

• Prior experience working in rapidly growing pharmaceutical organizations is desirable

• A thorough understanding and experience with the development and licensure of  biologic drugs for orphan and pediatric  indications along with knowledge of and monitoring of the evolving landscape of regulations and guidelines

• A strong scientific background and ability to interact with scientists and clinicians

• Ability to speak and interact with a diverse group of individuals on technical and business topics

• Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally

• Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities, optimizing their effectiveness to enable the timely and quality creation of local submissions

• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills

• Track record of successful interactions with regulatory and health authorities

• You are a connector, building relationships and partnering across the organization to achieve the company goals

• You excel in a fast-paced, results-driven, highly accountable environment

• You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done

• You show strong leadership with proven ability to build, motivate and develop a team

• You resonate with the values of argenx and you are ready to drive the Company Culture

• You combine strategic thinking with the ability to execute, both individually and by leading teams to achieve operational excellence in the face of challenging goal