Employment Law - General Attorney in Waltham, MA

In-House

Waltham, MA

Employment Law - General Attorney in Waltham, MA

Attorney

Min 7 yrs required

No

Please do not send agency resumes to our website or to any of our employees. We are not responsible for any fees related to unsolicited resumes.



Senior Director, Commercialization and Development Counsel

Position Summary:

The Senior Director, Commercialization and Development Counsel will provide legal counsel and business advice to leadership and various teams within **Members Only** This includes guidance on laws, policies, and strategies related to drug development, regulatory affairs, marketing, market access, medical affairs, and drug safety. The ideal candidate will have experience in both law firms and biotech/pharmaceutical companies, with a focus on drug development, commercialization, and launches.

Responsibilities:

- Provide legal counsel and business advice on the development and commercialization of Invivyd's product candidates
- Advise on FDA and global regulatory matters and ensure compliance with relevant laws, regulations, and industry standards throughout the product lifecycle
- Provide legal expertise on healthcare laws, including the Federal Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, and more
- Advise on clinical trial programs and drug development pathways
- Counsel the Marketing team on innovative strategies, activities, and programs, including serving as the Legal representative for reviewing advertising and promotional materials
- Advise the Market Access team on payer strategies, government pricing compliance, distribution models, and more
- Provide legal guidance to the Medical Affairs team on communications, engagements, and other activities
- Support government affairs strategies and initiatives
- Review materials for the Corporate Affairs team, including social media posts
- Counsel the Regulatory and Drug Safety teams
- Assist in creating and maintaining a robust corporate compliance program
- Collaborate with other Legal and Compliance department members to provide consistent and efficient support to the company
- Represent the Legal department on cross-functional initiatives
- Research legal issues and provide advice to internal clients
- Manage outside counsel resourcing and budget for complex areas of law

Requirements:

- Juris Doctor (.) from an ABA-accredited law school, with an active license to practice in the state of residence
- Minimum of 7 years of relevant experience in a pharmaceutical/biopharma company or law firm
- Expertise in federal and state laws, regulations, and industry codes impacting pharmaceutical manufacturers
- Experience supporting regulatory and commercialization teams, including providing legal counsel on promotional activities, market access communications, and product launches
- Knowledge of enforcement landscape and industry litigation
- Strong judgment, ethics, and maturity
- Self-motivated and able to work independently
- Strong communication and leadership skills
- Familiarity with digital and social media regulations and policies
- Experience with compliance policies and procedures
- Ability to be a valued business partner and work collaboratively in a fast-paced environment
- Proactive and able to identify potential issues and provide solutions
- Positive and growth-oriented mindset
- Willingness to learn the business and build relationships with clients
- Ability to travel periodically for company meetings

At Invivyd, we value diversity and strive to create an inclusive environment. We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected characteristics.

Please note that we do not accept unsolicited resumes from agencies and are not responsible for any fees related to unsolicited resumes.