Senior Counsel, Research

4 weeks ago

South San Francisco, United States Genentech Full time

The Position

The Genentech R&D Law Group is seeking a highly experienced R&D attorney. As a partner and key business strategist, this individual will have deep experience in regulatory law and complex transactional legal support for global strategies and activities related to product research and development, digital health and personalized healthcare.

As a member of the R&D Law Group, this individual will primarily support Genentech's Research and Early Development (gRED), Global Product Development and Medical Affairs functions by providing strategic legal advice to advance the company's pipeline; including: drug, device, digital and integrated solutions.

This position will be based onsite in South San Francisco, California or Little Falls, New Jersey. Relocation benefits are not available for this posting.

Key Responsibilities:

Key responsibilities will include but not limited to:

* Providing legal advice, education, and actively resolving legal issues related to the following:
* Conducting early research through clinical trials (GxP compliance, diversity in clinical trials, subject recruitment and retention, decentralized trials, patient safety and pharmacovigilance, informed consent and research privacy, etc.);


* Biomarker, genomic research and emerging data and digital solutions pertinent to R&D;


* Real World Data and secondary use of research data; and


* Pre-approval and expanded access to investigational medicinal products.




* Serving as lead legal counsel for global development programs involving innovative scientific initiatives with external collaborators including pharmaceutical manufacturers, digital or device developers, academic institutions, research collaborative groups, and government entities;


* Proactively identifying and addressing legal issues, fostering trusted relationships with client groups, advising leaders in the research and development and medical affairs organizations and serving as a standing or ad hoc member of business or leadership team(s); and


* Consulting and collaborating with internal and external stakeholders and subject matter experts to support the above activities, including IP, transactional, privacy and product attorneys, as well as business leadership, regulatory experts, ethics experts and legal policy committee members.



For this position, we are seeking an attorney with the following qualifications:

* JD required, must be licensed and currently in good standing to practice law in one or more jurisdictions.


* Must have at least 7 years of recent relevant legal experience.


* Must be able to work global working hours.


* Must have significant knowledge of the human subject protection laws, Federal Food, Drug and Cosmetic Act and related regulations, US and global privacy laws, and other applicable federal and state laws governing the research and development of human therapeutics.


* Must have significant transactional experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, companion diagnostic developments, complex research collaborations and consortia.



Critical Competencies:

Strategic R&D Expert:

* Demonstrated success in proactively and independently driving for and delivering results with high impact on matters related to pharmaceutical research and development.


* Ability to approach complex problems with a creative and growth mindset.


* Experience with medical device R&D and digital health is helpful though not required, but a willingness to learn is a must.



Influential Communicator and Influencer:

* Excellent verbal and written communication skills, awareness and ability to engage with others of diverse backgrounds.


* Excellent judgment and superior client-relations skills, and the organizational savvy to effectively collaborate with and influence multidisciplinary, diverse and global clients and colleagues.


* Ability to deliver clear, concise and practical advice regarding challenging legal issues to legal and non-legal colleagues, including senior management.



Adaptive Performer and Systems-wide Collaborator:

* Ability to prioritize and work with agility across multiple projects.


* Ability to work both in a team and independently.


* Aptitude and interest to learn the scientific/technical side of the business.


* Comfortable with getting outside of one's comfort zone, and stepping into new areas of practice or business.



The R&D Law Group, as part of the Genentech Corporate 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.

The expected salary range for this position based on the primary location of California is $198,500 to $368,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

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