Vice President, Global Regulatory

NextCure Inc•Beltsville, MD

31d•Onsite

About The Position

NextCure seeks a highly motivated Vice President, Global Regulatory based in our Beltsville, Maryland offices. The executive will possess global regulatory experience to lead regulatory strategies and filings for our portfolio of first-in-class and best-in-class antibody-drug conjugate (ADC) product candidates. This position reports directly to the Chief Operating Officer. NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville Maryland committed to discovering and developing novel first-in-class and best-in-class therapies to treat cancer. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development. We are excited about the ongoing work at NextCure and invite you to come join us in the culture and build your career in an environment that nurtures professional growth and development. The executive will define and implement innovative regulatory strategies around the globe to expedite development and approval of our ADCs. The executive will formulate the communication strategy and lead interactions with all regulatory authorities, provide strategic regulatory leadership across clinical development and manufacturing activities and provide regulatory guidance throughout the drug development lifecycle to ensure alignment with evolving regulatory requirements and business objectives. The executive also will drive discussion and regulatory decision making with existing partners and with third party vendors, including CROs and CDMOs. This role requires a seasoned executive with in-depth knowledge of US FDA, Health Canada, Europe’s EMA, China’s NMPA, Japan’s PMDA, Australia’s TGA, Korea’s MFDS, Brazil’s ANVISA, India’s CDSCO, South Africa’s SAHPRA and other international regulatory pathways. In addition, exceptional leadership skills and the ability to collaborate cross-functionally with clinical, manufacturing and research teams will also be required. The successful executive will thrive and adapt to a fast-paced environment focused on global expansion and possess a passion for uniquely positioning ADC therapies.

Requirements

Advanced degree (PhD, PharmD, MD, or equivalent) in a scientific or regulatory discipline
Minimum of 12 years of experience in regulatory affairs in the biotech or pharmaceutical industry, with at least 8 years in oncology supporting antibody-drug conjugates
Proven track record of designing successful global regulatory strategies resulting in product approvals, including Fast Track, NDA, BLA, or MAA
In-depth knowledge of FDA, Health Canada, EMA, NMPA, PMDA, TGA, ANVISA, MFDS, CDSCO, SAHPRA and other international regulatory agencies regulations and guidance documents, with particular attention to issues relating to antibody-drug conjugate development
Outstanding project management and organizational skills with respect to preparations for major regulatory filings including IND, breakthrough designation, fast frack approval, NDA, BLA, major briefing documents for meetings including End of Phase 1 and Phase 2, Type C and D, and other key interactions with regulatory agencies and other health authorities
Strong leadership, strategic thinking and negotiation skills
Ability to thrive in a rapidly changing environment, recommend and implement solutions with a proven ability to collaborate, operate and influence cross-functionally and cross-culturally
Excellent analytical, oral, and written communication skills and stakeholder management abilities
Ability to multitask and perform in a fast-paced entrepreneurial and growing environment

Responsibilities

Lead the creation and execution of comprehensive global regulatory strategies for antibody-drug conjugate (ADCs) programs across all phases of product development, including clinical development, manufacturing and commercialization
Lead global interactions and discussions with regulatory authorities, from pre-IND stage to final approval and commercialization
Serve as strategic advisor to executive leadership and cross-functional teams on regulatory risks, opportunities, and timelines
Manage cross-department interactions necessary to support regulatory filings for nonclinical pharm tox, manufacturing and clinical activities
Prepare and submit all regulatory documents, all associated amendments and supplements, and any other communications to regulatory authorities on a global basis
Assess regulatory risks associated with various drug development activities and advise product development teams and/or senior management on possible solutions to mitigate such risks
Manage interactions, discussions, and decision making with third party vendors, including CROs, CDMOs and any other outside regulatory-related resources, as needed
Lead regulatory discussion and communication with existing and new strategic partners
Provide due diligence support and advice to business development and licensing colleagues, as needed
Represent the regulatory affairs function in internal and external meetings
Provide strategy and communications surrounding ongoing global regulatory activities and collaborate with project management to drive these activities to completion
Maintain up-to-date working knowledge on relevant global regulatory regulations, guidance, and the current regulatory environment
Participation in due diligence activities and/or reviews of potential licensing candidates