Transforming Cancer Therapy Together

At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives.

Why ADC Therapeutics?

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States, conditional approval from the European Commission and conditional approvals in other countries. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as in indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use.

We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn.

What You’ll Do:

This critical position is responsible for leading the preparation and maintenance of INDs, BLAs and clinical trial applications e.g CTR that are compliant with US, foreign regulatory requirements, and company standards. The incumbent will act as the regulatory lead on assigned project teams, providing regulatory leadership, guidance and oversight.

Reporting to the Head of Global Regulatory Affairs, this role can be remote/hybrid. Some travel to the New Providence, NJ office will be required once a quarter or more as needed.

Job Responsibilities:

• Act as the primary regulatory representative on, and provide strategic regulatory guidance to, assigned project teams and sub-teams
• Lead the planning and preparation of global regulatory global submissions (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions)
• Management of, and collaboration with, CRO partners for regulatory submissions
• Represent Regulatory Affairs with licensing partners
• Establish and manage regulatory timelines
• Serve as the liaison between the company and global health authorities, including FDA, for assigned projects
• Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies including developing strategies for such meetings
• Participate and provide regulatory guidance at weekly MLR meetings. Escalate issues as needed
• Prepare regulatory development plans for assigned projects
• Develop and maintain regulatory knowledge of US, EU and ROW regulations
• Coordinate and prepare responses to Regulatory Agency requests for information
• Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
• Assist in maintaining active INDs/CTAs/CTRs/BLAs (amendments and annual reports)
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents

Who You Are:

• 15+ years’ experience in a biotech/pharmaceutical research environment, including 10+ years in Regulatory Affairs
• Minimum of a Bachelor’s degree in a scientific discipline or equivalent, with PhD or Master’s degree preferred
• Experience in regulatory strategic support to all phases of drug development
• Experience in preparation, submission, and FDA review of INDs, BLAs or NDAs
• Experience with Marketing/Legal Review (MLR) committees is preferred
• Experience in oncology drug development strongly preferred including, for example, immuno-oncology, hematology, ADCs and other bio-pharmaceuticals
• EU regulatory experience preferred including CTR
• Prior people management experience preferred
• Team player who can collaborate and work successfully with multiple key stakeholders including external CROs
• Ability to successfully handle multiple, competing tasks in a fast-growing company environment
• Strong verbal and written communication skills
• Requires a highly motivated, resourceful, individual who can set goals, shift priorities, work independently and collaborate effectively with project teams
• Good organizational skills and attention to detail

Join Our Inclusive Team

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.