Product Counsel Jobs

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases. We are developing vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) with a New Drug Application under review by the FDA for the treatment of Erosive GERD and a late-stage development program in Non-Erosive GERD. Vonoprazan-based regimens are approved in the U.S. as part of a co-packaged product in combination with antibiotics for the treatment of H. pylori infection in adults, marketed as VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK® (vonoprazan, amoxicillin).

We are a growing team of highly driven professionals who are passionate in our mission to improve the lives of people suffering from GI diseases. Phathom has built a unique culture that embraces entrepreneurship, fosters collective ownership and accountability, and celebrates personal and professional achievement. We are looking for dynamic, self-motivated, and purpose-driven team players who embody our core values and are excited by the idea of working in a fast-paced environment to help us transform the GI treatment landscape.

The Director, Product Counsel serves as the lead product counsel for Phathom’s marketed products and products in development. This is a dynamic position supporting multiple client groups, including teams within Phathom’s Marketing, Market Access, Sales, Medical Affairs, and Communications functions, providing advice on matters related to promotional and educational activities, engagements with healthcare providers and entities, and other applications of commercial law and regulatory compliance in the biopharmaceutical industry.

The Director, Product Counsel will also have significant interaction with Regulatory Affairs, Clinical Development, IT and other functions throughout Phathom.

This position requires a problem-solving mindset, a high degree of collaboration with internal clients and colleagues, and the ability to exercise mature and reliable judgment in the company’s fast-paced environment.

The role and the company are flexible, permitting a combination of remote and in-office days weekly.

ACCOUNTABILITIES

• Provides advice, guidance and counsel to commercial, medical and corporate teams on sales and marketing strategies, programs, policies, practices and initiatives with respect to compliance with relevant U.S. healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance, fraud and abuse laws, anti-kickback statutes, federal and state transparency laws, OIG Advisory Opinions, PhRMA Code, etc.).
• Engages and efficiently manages external counsel as appropriate.
• Supports medical and commercial development for assigned products, including regulatory and medical strategies, product safety, product liability analyses and risk-mitigation activities and label development.
• Supports execution of a robust healthcare compliance program, including creation and enforcement of company policies and procedures, risk assessments and ongoing monitoring.
• Serves as the legal representative on cross-functional Medical Review Committee to provide legal feedback and direction on medical affairs materials and activities.
• Reviews and provides legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations.
• Advises on contracting and transactional issues and engaging with contracting counterparties as needed.
• Serves as the legal representative on cross-functional Promotional Review Committee to provide legal feedback and direction on advertising, promotional and educational materials submitted for review.
• Provides legal and compliance training to field and home office Phathom personnel and external consultants, including large group public speaking.
• Actively contributes to the legal and compliance team by sharing best practices and participating in initiatives focused on building departmental and functional knowledge and competencies.

EDUCATION AND EXPERIENCE

• Knowledge and experience with managed markets, payer and PBM contracting, patient support programs and/or government pricing a plus.
• Minimum of 5 years of professional work experience at a law firm or in-house legal department.
• Juris Doctorate or equivalent law degree required.
• Minimum of 3 years in support of the pharmaceutical or biotech industry, whether as in-house counsel (pharma/biotech preferred) or in a law firm, including experience in regulatory law and commercial-related matters.
• Admission to New Jersey Bar or ability to obtain NJ in-house limited license.
• Strong sense of integrity, business transaction transparency and the ability to balance business interests with the need to exercise independent judgment.
• Proven capacity to cultivate strong client relationships and successfully influence leadership in a dynamic, innovative business climate.
• Ability to analyze and interpret technical procedures, government regulations and legal documents.
• Demonstrated ability to grasp statutory and regulatory concepts quickly, and proactively identify and analyze potential legal issues and provide thoughtful and creative business-focused legal advice and solutions.
• A thorough understanding of regulatory and legal frameworks governing the sales and marketing of approved medicines, and regulatory framework for investigational medicines.
• Exceptional attention to detail and deadlines.
• Ability to work independently and in a fast-paced environment and handle multiple complex and confidential tasks.
• Excellent communication and interpersonal skills.
• Knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including FDCA, FDA guidance, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines and state marketing compliance laws.

[MHK1]What is minimum education required? If JD remove bachelor and equivalent. If JD preferred, what is minimum education requirement?

[WA2]I should likely have included this the first go-round.

[JN3]5 years work experience to include some years at a law firm or in-house legal department

[JN4]Pharma/biotech preferred?

• [WA5]Added in the statement.