Genentech is expanding its Personalized Healthcare Business by investing in digital health tools that inform and tailor clinical decision-making by generating or using real world data, including sensor-based measures (e.g. via a smartphone, wearables or other sensors and connected devices) and digital tools to integrate data into care.
The Senior Corporate Counsel/Assistant General Counsel will work as part of the Global Functional Practice Group in the Healthcare Law Group within Genentech's Legal department. The Global Functional Practice Group supports activities conducted by teams operating globally with respect to issues related to product development, Personalized Healthcare, Data privacy, Pharmacovigilance, Trade Compliance, and Manufacturing and Quality Compliance.
This position will primarily support Personalized Healthcare initiatives in connection with issues related to research and development of innovation of Digital Health products, medical devices, related pharmaceutical products. The attorney will provide strategic counsel to key internal functions in Global Product Strategy (GPS) and Pharma Product Development (PD) with strategic responsibility and oversight for the development and oversight of strategies and capabilities required to effectively develop and launch a portfolio of Digital Health assets.
Activities for this position will include the following:
- Providing Digital Health legal guidance and expertise to global and US Affiliate functional areas;
- Working closely with key functions, including Digital Health Platform teams, PD, GPS, Medical Affairs, Regulatory, Informatics, Commercial and other Roche Affiliates (Flatiron, FMI, Roche Diagnostics, Roche Diabetes Care, etc.) to advise on the company’s Digital Health strategy across disease areas;
- Collaborating with patent and transactional attorneys to support Personalized Healthcare partnerships and collaborations;
- Advising product lifecycle teams, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations, privacy, data use, and other potential company obligations, liabilities and related risk mitigation;
- Providing advice, education, training and legal direction on healthcare fraud and abuse laws, antitrust, privacy and other laws impacting business operations and contractual relationships related to research, development and launch of digital health products;
- Interpreting company policies and developing risk mitigation strategies relating to conducting clinical trials, providing funding for scientific research, software product releases to patients and providers, data sharing, patient recruitment, anti-kickback rules, informed consent requirements, and privacy protections;
- Serving as lead legal counsel for global development programs involving innovative scientific initiatives with industry collaborators including pharmaceutical manufacturers, academic institutions, research collaborative groups, and government entities; and
- Negotiating agreements and providing counsel regarding contracting with health care professionals, institutions, study sites, foundations, cooperative groups, and government entities.
The position may also have the opportunity to provide legal advice and support across the lifecycle of Genentech's products. Specific activities may include:
- Providing advice, education, training and legal direction on FDA labeling and promotional matters, medical device health apps, health informatics, digital therapeutics, and clinical decision support software tools, and Software as a Medical Device (SaMD) regulation, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws and enforcement trends impacting the commercialization of medical device and biotech products;
- Advising clinical, product development, regulatory, medical affairs, and other clients on good clinical practice, human subject protection, research on human tissue samples, conflict of interest policies, FDA regulatory submissions, label negotiations and privacy and data use; and
- Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities.
We are looking for a Digital Health expert who can:
- Provide strategic advice and innovative thought partnership to cross-functional teams in a decentralized and matrixed global environment;
- Work collaboratively and effectively in a fast-paced, rapidly evolving environment to achieve the best outcomes for patients in a sustainable manner
- Demonstrate comfort and experience engaging senior leaders in digital health discussions, with the ability to actively shape these conversations and build credible and empowered relationships
- Bring deep experience of and insights into digital health market, including in areas such as health apps, health informatics, digital therapeutics, and clinical decision support software tools software as a medical device
- Align resources to achieve key business priorities, including working with external partners
- 8-15 years in practice, including between 5-7 years of relevant legal experience at a law firm with a nationally-recognized Technology, FDA, Life Sciences practice or in a technology, medical device pharmaceutical or biotechnology company’s law department, with a focus on counseling medical device, digital health, pharmaceutical and/or clinical clients on U.S. and international rules related to the promotion, clinical development, and manufacture of human medicines and companion diagnostics
- J.D. with Bar admission from a top-tier law school
- Significant knowledge of digital health regulations around mobile medical apps, digital therapeutics, and real world evidence as well as the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the medical device, pharmaceutical and biotech industries is essential.
- Excellent oral and written communications skills are a must.
- Demonstrated leadership on cross-functional teams and the ability to be influential in presenting complex information to all levels of management are also expected of the candidate to be successful in the role.
The Healthcare Law Group, as part of the Genentech Law Department, values ongoing professional development and collegiality in support of our vision to be essential partners to our clients, driving business excellence to improve patient lives. We seek and cultivate self-motivated individuals who share this vision and consistently demonstrate excellent judgment and ethics while delivering solutions-oriented, proactive, and strategic legal advice.