Location: New Haven, CT (Northeast preferred)

Position Summary:

The Associate Director, Contracts Counsel will support the contracts function for Invivyd, working across functions and teams as a trusted partner to proactively facilitate the efficient drafting, negotiation, execution, and tracking of contracts.  The ideal candidate will demonstrate a focus on collaboration, professionalism, confidentiality, superior organizational and prioritization skills, and a high level of attention to detail.  The Associate Director, Contracts Counsel will leverage knowledge of applicable laws and regulations, and risk management strategies to advise and serve as a business partner to the organization. 

Responsibilities:

• Own the triaging process of contract requests as they are received by the legal department
• Draft, review and negotiate a high volume and wide range of agreements, including master services, statements of work, clinical research organization, clinical trial, supply, consulting, confidentiality, sponsored research, material transfer, and any related legal documents required to support the company goals and in accordance with Invivyd’s legal standards, independently, as well as in coordination with internal and external counsel (as applicable with complexity of agreement)
• Coordinate and liaise with multiple internal stakeholders, outside counsel, and counterparties to ensure timely preparation, review, negotiation, execution, tracking, and management of contracts
• Facilitate internal contract approval and execution in line with delegation of authority
• Advise internal clients on contract interpretation, obligations, risk exposure, dispute resolution, and other legal matters in a pragmatic way that results in actionable business advice
• Coordinate and collaborate with finance and the business to develop spend approval, reporting, and purchasing processes, and assist in managing obligations (e.g., milestones, deliverables, invoicing)
• Assist in the training of junior contracting staff and/or outside resources, as applicable
• Improve and maintain contract policies, procedures, and processes, including by reducing cycle times and increasing efficiency
• Represent the legal department and/or contracts function on special projects and cross-functional initiatives; collaborate with other members of the legal department on internal initiatives
• Own and train on the records retention policy
• Support the culture of the legal department as a valued business partner by working collaboratively with key stakeholders (including senior management, internal clients, intellectual property, and finance), gaining a deep understanding of the business and its needs, and implementing a pragmatic approach to contracting consistent with those needs

Requirements:

• Juris Doctor (J.D.) from an ABA-accredited law school; attorney in good standing with license to practice in the state where you reside
• Minimum 3-5 years demonstrated experience independently drafting, reviewing, and negotiating contracts with substantial experience in pharmaceutical or biotechnology industry, including experience in a commercial stage company
• Ability to analyze complex contracts and legal documents and provide concise, actionable feedback
• Understanding of the unique risks and considerations for the life sciences industry to identify and mitigate risks through contracting, such as drug development and intellectual property considerations, privacy laws, and fraud and abuse laws
• Strong attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously
• Excellent written and verbal communication skills with the ability to interact effectively with internal teams, external vendors, and legal counsel
• Ability to work independently and as part of a collaborative, fast-paced team environment; positive, can-do attitude with growth-mindset and enterprise leader approach
• Demonstrated business acumen; highly skilled at integrating legal advice with business acumen and sound judgment
• Commitment to integrity and ethical conduct and ability to handle confidential and proprietary information with discretion and sound judgment
• Ability to travel to HQ office 2-4x a month

Pay Range

$152,000 - $202,000

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.

Location: (Northeast preferred) Invivyd's headquarters is in New Haven, CT. This role will be a hybrid role with onsite presence approximately 5-10 days a month in the New Haven, CT office.

Position Summary:

The Vice President, Associate General Counsel, Infectious Disease Franchise will be responsible for providing legal counsel and business advice to, as well as preparing and reviewing materials for Commercial, Clinical, Regulatory, Medical and Pharmacovigilance leadership and the Marketing, Market Access, Clinical and Clinical Operations, Regulatory Affairs, Medical Affairs, Drug Safety, and Patient Advocacy teams, among others, in part, such as Corporate Affairs and Corporate Communications, on relevant areas of law, policy, business opportunity, risk, and mitigation strategies. The ideal candidate will have significant experience in a law firm and/or pharmaceutical or biopharma company(ies) with all stages of drug development, with a key focus on commercialization and product launches.  Responsibilities include providing legal advice and business counsel to leadership and the business and creating and reviewing materials concerning a broad range of legal issues, including application and interpretation of laws, regulations, guidance, code and process in connection with drug development, regulatory strategy, product labeling, promotional and non-promotional activities, medical strategies and activities, marketing and market access strategies and activities, interactions with formulary decisionmakers and healthcare professionals, patient advocacy engagement, among other areas such as corporate communications.

Reporting to the Chief Legal Officer, this position will be part of a dynamic Legal and Compliance team.

The ideal candidate will have strong substantial experience at biopharmaceutical/pharmaceutical company(ies) in the relevant areas identified above and below, with extensive experience as commercialization counsel, and law firm experience (preferred), with a preference for law firm experience advising pharmaceutical/biopharmaceutical companies, and .

The ideal candidate is someone who thrives in a fast-paced environment, who is a critical thinker, issue spotter, and strategic problem solver, and who is proactive, flexible, detail-oriented, and hands-on. 

Responsibilities include, but are not limited to, the following:

• Providing strategic, operational and tactical legal counsel and business advice related to the development and commercialization of Invivyd’s product(s) and product candidate(s)
• Advising clients on FDA (and global regulatory authority) regulatory matters and compliance with laws, rules, regulations, guidance and industry standards that arise throughout a product lifecycle, including in the areas of product development, regulatory submissions, advertising and promotion, and drug safety
• Providing legal counsel on health care laws, including the Federal Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC, HIPAA, CAN-SPAM, state laws on physician gifts/meals, Sunshine Act, state price transparency reporting, product liability statutes and related health care legal obligations
• Providing legal advice, business counsel, material review and creation (e.g., informed consent forms, clinicaltrial.gov postings, FDA correspondence and submissions,) to Clinical, Clinical Operations, Regulatory Affairs, Pharmacovigilance relating to clinical trial programs and drug development
• Providing legal advice, business counsel and training (building and delivering) to the Marketing team on innovative marketing strategies, activities, programs and trainings, including serving as the Legal representative on the Company committee responsible for the review of advertising and promotional strategies and materials, digital and social media initiatives, and working with clients to develop appropriate and compliant strategies for interacting with healthcare providers and other stakeholders
• Providing legal advice, business counsel and training (building and delivering) to the Market Access team, including advice on developing and implementing payer strategies, pre-approval information exchange materials, distribution models and materials, patient support programs, HEOR studies and communications
• Providing legal advice, business counsel and training (building and delivering) to the Medical Affairs team on proactive and reactive communications (i.e., scientific exchange, research planning and support, publications), presentations, engagements and other activities; serving as Legal representative on the Company committee responsible for the review of select scientific exchange
• Reviewing materials for Corporate Affairs (communications) team, including social media posts
• Working closely with other Legal and Compliance department colleagues to provide consistent and efficient legal and compliance support to the Company. Supporting the creation, review, updating and training of corporate and healthcare compliance policies, SOPs, rules of engagement, and laws, regulations, guidance and codes
• Providing and coordinating legal support as a member of cross-functional teams
• Representing the Legal department on cross-functional initiatives and collaborating with other members of the Legal department on internal initiatives
• Researching issues and supporting the company in providing a wide range of legal advice to internal clients
• Managing outside counsel resourcing and budget for complex or nuanced areas of law, regulation or policy
• Lead or support internal investigations on behalf of Legal; lead or support external investigations or litigation, independently, collaboratively, and/or with outside counsel support, as applicable
• Potential for management of one or more legal teams (e.g., Contracts) and/or direct reports, in role currently or to be hired

Required Skills:

• Have a Juris Doctor (J.D.) from an ABA-accredited law school; be a licensed attorney in at least one U.S. state and in good standing in all states where you are licensed; and have the ability to obtain CT in-house counsel registration
• A minimum of 10 years of relevant experience with a pharmaceutical/biopharma company (can be combined with relevant experience at a law firm) providing relevant life sciences advice, counsel and support to pharma/biopharma companies
• Demonstrated expertise in relevant federal and state laws, regulations, rules and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, including but not limited to applicable law concerning drug labeling, advertising and promotion, scientific exchange, market access communications, government reimbursement and product liability
• Demonstrated experience supporting regulatory and commercialization teams including providing legal counsel on Medical, Legal, Regulatory review committee, development and implementation of promotional activities, market access communications, drug labeling, scientific exchange. Product launch experience strongly preferred. Buy and bill experience a plus
• Experience supporting regulatory affairs and drug safety in pharmaceutical development and ongoing obligations
• Knowledge of enforcement landscape, including relevant industry litigation, settlements, and corporate integrity agreement obligations
• Demonstrated senior leadership and personnel management skills and experience
• Litigation experience a plus

Additional Requirements:

• Possess and demonstrate exceptional judgment, self-management, impeccable ethics and a high degree of personal and professional maturity
• Strong sense of accountability and ownership
• History of self-motivation, sound judgment and excellent interpersonal relations including being a team player and building collaborative, effective relationships within the Legal and Compliance Department and with other functions
• Demonstrated experience in thinking critically and connecting the dots across broad areas to identify and analyze complex, novel, and challenging issues, well-articulating the risk and potential consequences for transparent decision making, and timely providing compliant, practical, creative and implementable solutions
• Excellent communication skills (both verbal and written); strong leadership skills
• Experience with digital and social media policies, regulations, guidance and industry practice
• Experience drafting, reviewing and/or interpreting and advising upon written compliance
• Demonstrated ability to be a valued business partner
• Exceptional multi-tasker with strong work ethic to deliver timely, high-quality work product
• Thrive in a fast-paced, rapidly evolving environment and view obstacles as opportunities
• Proactive in identifying issues, opportunities and solutions for short and long-term success and growth for the business and legal team
• Highly collaborative; ability to work independently and as a teammate in a remote environment
• Positive, growth mindset
• Interest and ability to learn the business and the science, and build relationships with clients to effectively prioritize and deliver exceptional results
• Team player willing to support the legal team and business on broader initiatives and pitch-in where needed
• Strong interpersonal, written and verbal communications skills
• Strong problem-solving and decision-making skills with demonstrated ability to think creatively and devise solutions to challenging problems
• Have a high-quality and continuous improvement orientation, ensuring we are staying current with relevant laws, regulations, guidance, policies and codes in how we identify and mitigate risk and provide solutions to the business
• This role is based at Invivyd’s office in New Haven, CT (minimum 3 days a week onsite). Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture
• Ability to periodically travel (e.g., to attend company off-site meetings; field ride-alongs/program monitoring; attend meetings on behalf of Invivyd, such as conferences/congresses), as directed. Travel is an essential job function

Pay Range

$309,000 - $383,000

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.

Location: New Haven, CT (Northeast preferred)

Position summary: 

Invivyd is seeking an experienced healthcare compliance professional to join the Ethics & Compliance Team, reporting to the Vice President, Chief Ethics, Compliance & Privacy Officer.  This individual will play a critical role in designing, building, implementing, and maintaining an effective compliance program that embeds a culture of compliance across all levels and departments of the organization.  The role will involve hands-on program development and collaboration with business partners to ensure Invivyd is well-positioned to comply with healthcare-related laws, regulations, industry codes, and the Company’s Code of Business Ethics and Conduct. He/she will assist in the creation and update of policies and training, conducting monitoring and risk assessment, and other aspects of an effective compliance program.  Ideally, this role will also support and oversee privacy compliance, data governance and strategy, and privacy incident management and response.  Ultimately, this professional will help shape the company’s culture to enable achievement of its goals in a compliant and ethical manner.   

Responsibilities:   

• Policies:
  • Work collaboratively across the business to help develop, evolve and oversee implementation of policies, procedures, and guidance that are right sized for Invivyd and reflective of existing and updates to applicable laws, rules, regulations, guidance, industry codes, and Company policies
  • Periodically update relevant policies and procedures, ensuring they are appropriately tailored to the risks associated with the business
• Privacy:
  • Lead or assist in the development of a comprehensive privacy program, right-sized for Invivyd and counsel internal clients on a wide range of privacy matters, including permissible data uses for strategic initiatives and the application relevant privacy laws and regulatory guidance to current business processes, research collaborations, and commercial partnerships
• Training, Communications, & Culture
  • Develop and implement engaging communications, trainings, and other content to help employees understand company policies and guidance and be accountable for their role in building and maintaining a compliant and ethical organization
  • Assist in the development and roll-out of Compliance training and communication to Sales, Marketing, Market Access, Medical Affairs, and other relevant departments
• Monitoring:
  • Assist in the execution of a comprehensive compliance monitoring program relevant to each business function, including periodic field rides, observation of speaker programs, advisory boards, and sponsorship activities
• Systems:
  • Manage implementation and deployment of Compliance systems (e.g., end-to-end HCP engagement tools, sponsorship submissions and approvals) and coordinate with vendors, third parties and others to support the development, implementation, and maintenance of the compliance program
• Risk Assessments:
  • Support the design and execution of compliance risk assessments
• Culture, partnership, and guidance:
  • Foster a strong internal compliance, ethics, and “speak-up” culture by creating an environment in which employees see Compliance as a strategic partner
  • Provide advice and counsel to business partners from across the entire organization, evaluating business strategies and tactics for potential compliance risks
• Operations:
  • Assist in review and authorizing transactions where indicated by company policies, including HCP engagements and commercial sponsorships
  • Assist in preparation for compliance committee meetings
  • Provide additional support for ethics & compliance strategies and goals

Requirements:  

• Bachelor's degree in a relevant field
• Compliance and/or Legal background with a strong business partnership orientation; law degree or compliance certifications a plus
• Eight or more years of experience in U.S. healthcare compliance experience in pharmaceutical industry
• Subject matter experience with relevant laws and regulations, including:
  • U.S. anti-kickback laws and regulations, including the Federal Antikickback Statute
  • The Physician Payments Sunshine Act
  • Laws and regulations governing pharmaceutical industry
  • US privacy and consumer protection laws
  • The PhRMA Code on Interactions with Healthcare Professionals.
• Experience conducting internal monitoring
• Knowledge of commercial, compliance and regulatory matters related to the launch and subsequent commercialization of branded pharmaceutical products
• Knowledge of compliance and data privacy laws and standards, including but not limited to AKS, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, and state privacy laws
• Ability to develop strong working relationships and work effectively with cross-functional teams, multiple levels of management, external advisors, and others
• Must be able to travel to the corporate office 2-4x/month
• Ability to periodically travel (approximately 20%)

Pay Range

$184,000 - $245,000

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.