Invivyd
Senior Director, Commercialization and Development Counsel Northeast preferred
Invivyd, Waltham, Massachusetts, us, 02453
Senior Director, Commercialization and Development Counsel
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information. There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.
At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.
Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.
Be part of making a difference. Be part of Invivyd.
Position Summary The Senior Director, Commercialization and Development Counsel will be responsible for providing legal counsel and business advice to Commercial, Clinical, Medical, and Pharmacovigilance leadership, as well as to the Marketing, Market Access, Regulatory Affairs, Medical Affairs, and Drug Safety teams. The role requires expertise in law, policy, business opportunity, risk, and mitigation strategies relevant to biotech and pharmaceutical industries, especially in drug development, commercialization, and product launches.
Reporting to the Chief Legal Officer, this position will be part of a dynamic Legal team. The ideal candidate thrives in a fast-paced environment, is strategic, proactive, flexible, detail-oriented, and hands-on.
Responsibilities include, but are not limited to:
Providing strategic, operational, and tactical legal counsel related to product development and commercialization.
Advising on FDA and global regulatory matters, compliance, and industry standards throughout the product lifecycle.
Offering legal counsel on healthcare laws, including the Federal Anti-Kickback Statute, FDCA, False Claims Act, HIPAA, Sunshine Act, and related regulations.
Supporting clinical trial programs and drug development pathways with legal advice.
Providing legal guidance and training to Marketing on advertising, promotional strategies, and digital/social media initiatives.
Advising Market Access on payer strategies, pricing laws, and patient support programs.
Supporting Medical Affairs in scientific exchange, research, and publications, including review of communications.
Collaborating on government affairs strategies and supporting corporate communications, including social media review.
Providing legal support to Regulatory and Drug Safety teams.
Developing, reviewing, and training on compliance policies and procedures.
Managing outside counsel and legal budgets for complex legal areas.
Participating in cross-functional initiatives and conducting legal research to support the company.
Requirements :
Juris Doctor (J.D.) from an ABA-accredited law school, licensed to practice in your state, with the ability to obtain in-house counsel registration.
At least 7 years of relevant experience in biotech/pharma legal support, including drug development, commercialization, and product launches.
Deep knowledge of federal and state laws impacting pharmaceutical companies, including drug labeling, advertising, promotion, and scientific exchange.
Experience supporting regulatory, medical, legal, and compliance teams, with product launch experience preferred.
Knowledge of enforcement actions, industry litigation, and corporate integrity agreements.
Additional Requirements :
Exceptional judgment, ethics, and professionalism.
Strong ownership, accountability, and interpersonal skills.
Critical thinking, problem-solving, and risk assessment abilities.
Excellent communication and leadership skills.
Experience with digital/social media policies and compliance.
Ability to work independently and collaboratively in a fast-paced environment.
Growth mindset and proactive approach to legal and business challenges.
Strong interpersonal and multi-tasking skills, with a focus on high-quality, timely work.
#J-18808-Ljbffr
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information. There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.
At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.
Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.
Be part of making a difference. Be part of Invivyd.
Position Summary The Senior Director, Commercialization and Development Counsel will be responsible for providing legal counsel and business advice to Commercial, Clinical, Medical, and Pharmacovigilance leadership, as well as to the Marketing, Market Access, Regulatory Affairs, Medical Affairs, and Drug Safety teams. The role requires expertise in law, policy, business opportunity, risk, and mitigation strategies relevant to biotech and pharmaceutical industries, especially in drug development, commercialization, and product launches.
Reporting to the Chief Legal Officer, this position will be part of a dynamic Legal team. The ideal candidate thrives in a fast-paced environment, is strategic, proactive, flexible, detail-oriented, and hands-on.
Responsibilities include, but are not limited to:
Providing strategic, operational, and tactical legal counsel related to product development and commercialization.
Advising on FDA and global regulatory matters, compliance, and industry standards throughout the product lifecycle.
Offering legal counsel on healthcare laws, including the Federal Anti-Kickback Statute, FDCA, False Claims Act, HIPAA, Sunshine Act, and related regulations.
Supporting clinical trial programs and drug development pathways with legal advice.
Providing legal guidance and training to Marketing on advertising, promotional strategies, and digital/social media initiatives.
Advising Market Access on payer strategies, pricing laws, and patient support programs.
Supporting Medical Affairs in scientific exchange, research, and publications, including review of communications.
Collaborating on government affairs strategies and supporting corporate communications, including social media review.
Providing legal support to Regulatory and Drug Safety teams.
Developing, reviewing, and training on compliance policies and procedures.
Managing outside counsel and legal budgets for complex legal areas.
Participating in cross-functional initiatives and conducting legal research to support the company.
Requirements :
Juris Doctor (J.D.) from an ABA-accredited law school, licensed to practice in your state, with the ability to obtain in-house counsel registration.
At least 7 years of relevant experience in biotech/pharma legal support, including drug development, commercialization, and product launches.
Deep knowledge of federal and state laws impacting pharmaceutical companies, including drug labeling, advertising, promotion, and scientific exchange.
Experience supporting regulatory, medical, legal, and compliance teams, with product launch experience preferred.
Knowledge of enforcement actions, industry litigation, and corporate integrity agreements.
Additional Requirements :
Exceptional judgment, ethics, and professionalism.
Strong ownership, accountability, and interpersonal skills.
Critical thinking, problem-solving, and risk assessment abilities.
Excellent communication and leadership skills.
Experience with digital/social media policies and compliance.
Ability to work independently and collaboratively in a fast-paced environment.
Growth mindset and proactive approach to legal and business challenges.
Strong interpersonal and multi-tasking skills, with a focus on high-quality, timely work.
#J-18808-Ljbffr