Princeton Legal Search Group has been retained on an exclusive basis by Ferring Pharmaceuticals to lead the search for an experienced attorney for the position of Associate General Counsel – Oncology. As a privately-owned, specialty healthcare company with US headquarters in New Jersey, Ferring focuses on developing lifechanging innovations that help people live better lives. Ferring’s independence helps it cultivate an entrepreneurial spirit and long-term perspective that enables it to achieve growth and scale, while remaining agile and true to its ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
With the recent FDA approval of Adstiladrin® (nadofaragene firadenovec-vncg), Ferring is building a commercial and medical Uro-Oncology team. We are looking for candidates who share Ferring’s passion and dedication to help people live better lives. Adstiladrin®, a novel adenovirus vector-based gene therapy is the first gene therapy approved by the FDA for bladder cancer. Ferring’s team comprises passionate, driven, and collaborative individuals who are united in their commitment to deliver a new standard of care to patients, living with high grade, non-muscle invasive bladder cancer with or without papillary tumors, who are unresponsive to BCG – an area of critical unmet need.
Reporting to the U.S. General Counsel, the Associate General Counsel will serve on the Uro-Oncology leadership team, set legal strategy and policies, and provide high quality legal advice to ensure the success of commercial objectives for Ferring’s Uro-Oncology business while ensuring compliance with laws and regulations.
Responsibilities include:
- Analyze complex legal and business issues and recommend solutions for senior executives.
- Provide strategic commercial legal advice for the Uro-Oncology Division on matters pertaining to FDA regulatory law, drug advertising and promotion, sales training, public affairs, and social media. Ensure business objectives are achieved while aligned to and comply with relevant legislative and regulatory requirements.
- Provide legal advice in the areas of:
- Legal aspects of supporting customers (i.e. benefits investigations)
- Patient Support (program design and implementation)
- Label negotiation with FDA
- Contract review for HCPs and institutions, business partners and agents
- Participation in LMR, grants, and IITs
- Market access (pricing, contracting, risk-sharing agreements)
- Ongoing monitoring of Legal/Regulatory framework both Federal and State (e.g., gene therapy, bio-safety)
- Pro-actively identify and communicate potential legal issues to mitigate risk, in such areas as the Federal Anti-Kickback statute, regulatory safe harbors, Fales Claims Act, state fraud and abuse laws, anti-trust, anti-counterfeiting, reprocessing, warranties, HIPPA and other privacy laws.
- Provide strategic review of annual brand plans to ensure continued compliance.
- Collaborate with internal business clients, colleagues and external counsel to ensure these various programs meet compliance standards.
- Support company product launch initiatives
- Provide legal support for a range of activities associated with implementing patient assistance, reimbursement and support programs
Be an active, engaged and collegial member of the law department. Contribute in legal team meetings, generate ideas for continuous improvement of delivering legal services to our clients. Keep up with relevant changes in the law, legislation and health care industry.
Qualified candidates must hold a Juris Doctor degree from an accredited law school, admission to and current good standing with a state bar, and a minimum of 10+ years’ experience practicing law, preferably a substantial number of years in-house; 5+ years’ experience in FDA regulatory matters and health care law practice with a focus on pharmaceutical and biotechnology products; Oncology or gene therapy experience preferred but not required.
This is your opportunity to play an important role in making available to patients a novel product that has the potential to revolutionize the treatment of bladder cancer.
Submit Resume