SENIOR COMMERCIAL COUNSEL at Zydus Therapeutics Inc.

Hopewell Township, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Jul, 26

Salary

0.0

Posted On

23 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Legal strategy, Healthcare law, Pharmaceutical law, Regulatory compliance, Contract negotiation, Risk assessment, Product commercialization, Intellectual property, Medical affairs, Clinical development, FDA regulations, Anti-kickback statute, False claims act, HIPAA, Data privacy, Strategic brand planning

Industry

Pharmaceutical Manufacturing

Description

Description Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, saroglitazar, is a peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). As a wholly owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,400 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. The opportunity to empower people with the freedom to live healthier and more fulfilling lives is what makes a career with Zydus Therapeutics so rewarding. Our team is collaborative, innovative and adaptable. We are action-oriented and strive for excellence in all we do, all underpinned by respect, trust and integrity. We offer a wide variety of competitive benefits, services and support programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives If you are passionate about helping bring potential life-changing discoveries to patients, then you share our mission. ROLE SUMMARY Reporting to the General Counsel with a dotted line to the Chief Operating Officer, the Senior Commercial Counsel will be responsible for providing legal strategy and oversight for Zydus Therapeutics’ product pipeline—from late-stage development through launch and commercialization. They act as a strategic business partner, ensuring that marketing and scientific communications comply with complex healthcare laws while protecting the company's brand and intellectual property. Counsel will be embedded as a core team member, serving as a strategic legal advisor to multiple internal stakeholders including commercial, medical affairs, regulatory and clinical development. Counsel will advise the team based on their deep understanding of both the complex laws and regulations as well as business and strategic objectives related to the development and commercialization of specialty bio-pharmaceutical products. The Counsel will be pivotal to the success of the Company as the organization transitions into a commercial-stage biopharmaceutical organization. RESPONSIBILITIES · Provides day-to-day strategic and business-focused legal and risk counseling for saroglitazar and the emerging Zydus Therapeutics pipeline, from development through launch & commercialization, including advising on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, payer engagement strategies, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients. · Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease awareness, product communication, advertising and promotion, and strategic brand planning. · Reviews and approves all branded and non-branded materials, including advertising, social media and medical congress presentations. This is typically done through participation in a cross functional Medical, Legal, and Regulatory committee. · Negotiates, drafts, and reviews market access and customer-facing contracts including distribution, PBM, GPO, wholesaler/distribution, rebate/discount, and specialty pharmacy agreements. · Conducts risk assessments for organization and offers practical solutions that balance legal risk with corporate objectives. · Provides advice and guidance on all relevant federal and state healthcare laws, including the Federal Food, Drug, and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and HIPAA/data privacy. · Drafts and negotiate master services agreements, quality agreements, payer contracts, clinical trial agreements, and vendor contracts for global studies. · Provides additional legal support on various matters to the broader Regulatory and Legal team. · Collaborates with cross functional partners including commercial, medical affairs, regulatory and clinical development to sustain a culture of compliance and integrity. Requirements • JD with excellent law school credentials and admission to a state bar in any jurisdiction, with NJ preferred. • Have at least 5 years of legal experience at a nationally recognized law practice in the area of pharmaceutical and healthcare law or as an in-house attorney at a biotech/pharmaceutical company. • Previous experience as a product attorney at a pharmaceutical or biotechnology company preferred. • Comfortable operating in a growth-stage biotech environment with dynamic priorities, with proven ability to operate in a "hands-on" fast-paced environment. TRAVEL REQUIREMENTS • The position will require domestic and potentially international travel (up to 20%)

Responsibilities

The Senior Commercial Counsel provides legal strategy and oversight for product pipelines from development through commercialization. They act as a strategic business partner, ensuring marketing and scientific communications comply with complex healthcare laws.