Assistant General Counsel, Commercial & Medical

Celldex Therapeutics•Hampton, NJ

1d•$233,631 - $303,417

About The Position

This position provides comprehensive, strategic legal advice to the clinical, commercial, medical affairs, and market access teams for assigned therapeutic franchises and specific branded products. This role ensures that all product-related strategies, marketing campaigns, and clinical developments align with U.S. healthcare laws (FDA, OIG, anti-kickback, and privacy statutes) while effectively supporting the company's business objectives. Reporting to the SVP, General Counsel, this individual will partner closely with Commercial, Clinical Science, Clinical Operations, Medical Affairs, Regulatory Affairs, Compliance, Market Access, and Corporate Communications to support Celldex late stage and commercial assets. The position will also serve as legal advisor to the Vice-President of Health Care Compliance and Privacy. The position will also have responsibility to develop and lead Celldex’s advertising promotion review and approval process, providing strategic leadership, oversight, and direction for the regulatory review and approval of all promotional, non-promotional, and scientific communications for the company’s products. This role oversees the cross-functional Legal Medical Regulatory (LMR) operations, ensuring that commercial strategies are executed efficiently, competitively, and in strict compliance with FDA regulations, OIG guidelines, and company policies.This role will play a critical leadership position in Celldex's commercialization journey, helping shape promotional governance, legal review processes, training programs, and launch readiness activities. The successful candidate will combine deep expertise in FDA promotional regulations, scientific exchange, and pharmaceutical advertising and promotion law with strong business acumen and a pragmatic, solutions-oriented approach.

Requirements

Juris Doctor (J.D.) from an accredited law school.
8+ years of legal experience within a pharmaceutical, biotechnology, or life sciences organization and/or law firm supporting the industry.
Significant experience advising commercial organizations on advertising and promotion matters.
Deep expertise in FDA promotional regulations, OPDP guidance, scientific exchange, disease state communications, and Medical Affairs activities.
Demonstrated experience reviewing and advising on promotional materials across multiple channels, including digital, social media, and field-based communications.
Experience supporting product launches and commercialization activities. Prior participation in Promotional Review Committees (PRC/MLR); experience building or leading promotional governance processes preferred.
Strong understanding of FDA regulations, the Anti-Kickback Statute, False Claims Act, OIG guidance, PhRMA Code, and related healthcare laws.
Experience supporting Medical Affairs, publications, congress activities, advisory boards, and investigator-sponsored research.

Nice To Haves

Immunology, allergy, dermatology, or specialty biologics experience preferred.

Responsibilities

Serve as the primary legal advisor supporting all advertising and promotional activities for Celldex products and pipeline assets.
Provide legal guidance on promotional claims, product communications, scientific exchange activities, and disease state education programs.
Review and advise on HCP and consumer-facing promotional materials, including: Sales and marketing materials, Digital and social media content, Websites and digital campaigns, Speaker programs, Congress and convention materials, Disease awareness campaigns, Reimbursement and access communications, Patient support materials, Promotional training materials.
Provide practical, risk-based legal guidance that enables business objectives while ensuring regulatory compliance with both FDA and health care laws.
Recruit, mentor, and lead a high-performing team of Regulatory Advertising & Promotion professionals.
Allocate departmental resources and budget efficiently across multiple therapeutic areas, product franchises, and development pipelines.
Serve as Chair or Co-Chair of the Promotional Review Committee.
Lead legal and regulatory review of promotional materials and provide strategic guidance to cross-functional review teams.
Help establish scalable promotional governance processes and review standards to support commercialization.
Partner with Regulatory Affairs and Health Care Compliance to ensure consistent interpretation and application of promotional regulations and company policies.
Support development and continuous improvement of promotional review processes, standards, and training.
Develop and lead the LMR process, establishing clear key performance indicators (KPIs) for material turnaround times, content consistency, and review quality.
Drive the digital transformation of the promotional review pipeline, evaluating and implementing emerging technologies—such as Veeva Vault PromoMats, modular content systems, and Generative AI-driven compliance tools—to streamline workflows.
Establish standard operating procedures (SOPs) and corporate governance policies regarding promotional messaging, scientific exchange, and interactions with healthcare professionals (HCPs).
Provide legal counsel on scientific exchange activities and Medical Affairs engagements.
Advise on: MSL materials and field medical interactions, Medical information responses, Publications strategy and publication materials, Advisory boards, Investigator Initiated Studies (IIS), Congress activities and scientific presentations, Disease state education initiatives.
Partner with Medical Affairs leadership to distinguish promotional communications from scientific exchange activities.
Advise on FDA, OPDP, FTC, and related regulatory requirements governing promotional communications.
Assess legal and regulatory risks associated with promotional claims and marketing strategies.
Support responses to FDA or OPDP inquiries, comments, or enforcement actions related to promotional activities.
Monitor evolving legal and regulatory developments impacting advertising, promotion, scientific exchange, digital communications, and social media activities.
Partner with Regulatory Affairs and Compliance to implement appropriate risk mitigation strategies.
Serve as a strategic legal partner supporting launch planning and commercialization activities.
Help establish promotional governance, review processes, training programs, and launch-related policies.
Support development of launch materials, customer engagement strategies, reimbursement communications, and patient support initiatives.
Provide legal guidance on innovative commercialization approaches while balancing risk and business objectives.
Foster a lean-forward approach that supports innovation while maintaining compliance.
Develop and deliver training programs related to: Advertising and promotion, Scientific exchange, FDA promotional regulations, Field interactions, Digital and social media communications, Speaker programs, Advisory boards, Promotional governance.
Assist in developing policies, guidance documents, SOPs, and best practices supporting compliant commercialization.
Promote a culture of compliance while enabling business innovation.
Partner closely with Commercial, Medical Affairs, Regulatory Affairs, Compliance, Market Access, Corporate Communications, Patient Services, and Executive Leadership.
Serve as a trusted business advisor capable of balancing legal risk, regulatory requirements, and business objectives.
Support enterprise decision-making by providing practical, strategic legal counsel.