Invivyd

Facilitating and managing cross-functional Tech Ops projects, coordinating with external vendors, and ensuring timely project delivery. | Bachelor's in Life Science or related field with 7+ years of industry experience, experience with CDMO models, strong communication and organizational skills, and knowledge of biopharmaceutical development and GMP regulations. | ABOUT US 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. In October 2025, the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd. Location: New Haven, CT (Northeast Preferred) Position Summary: The Director, Project Management – Technical Operations will work closely with technical leads and cross-functional teams within and outside the company to facilitate meetings and interactions. This role requires attention to detail, strategic planning and organization skills, and effective collaboration to ensure clinical and commercial programs are supplied on time and on budget. Responsibilities: • Facilitate and manage interactions and meetings within Tech Ops and with outside vendors including agendas and minutes, action items. As required, interact with outside collaborators and partners to ensure alignment, reach consensus, and drive timely decision making. • Facilitate cross-functional integration and alignment between all Tech Ops functions including process development, analytical, formulation, manufacturing, quality, and supply chain. Maintain and administer timelines to ensure on-time deliverables for the group. • In collaboration with Tech Ops leadership, create the Tech Ops project plan (both short and long term) and ensure alignment and integration into overall program plan(s). Actively manage the plan, timelines and deliverables including tracking of project milestones, and driving near-term team decision-making with input from program team(s). • Develop and execute Tech Ops project specific risk management exercises such that project risks are systematically defined, quantified, assessed, and appropriately mitigated. • Plan/manage Tech Ops specific budgets, track expenditures and resource usage. • Assist with management of documents to support internal information management. Requirements: • Bachelor's degree in a Life Science or related field with a minimum of 10 years industry experience specifically in cross-functional management within Tech Ops, preferably manufacturing or development, or advanced degree and a minimum of 7 years of experience. • Experience in achieving project objectives through an outsourced CDMO model • Outstanding interpersonal skills. Excellent verbal and written communication skills. • Excellent organizational skills. Strong analytical and problem-solving skills. Ability to prioritize work and take initiative when necessary. • Ability to work well with external collaborators with professionalism and discretion. • A thorough understanding of the science and technology associated with biopharmaceutical product development, including functional interdependencies between development, manufacturing, quality, and supply chain at all program stages. • Experience in establishing and managing external CDMOs / CROs in coordination with Tech Ops technical leads to ensure timely delivery of clear, accurate and well written reports. • Strong knowledge of drug development and FDA/ICH guidance documents regarding GMP regulations. • Outstanding software skills, particularly Microsoft Project / Smartsheet and the Microsoft Office suite; expertise with project management tools (e.g. timelines, dashboards). At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Invivyd is proud to be an equal opportunity employer. We do not accept unsolicited resumes from agencies.

Manage and execute territory business plans, engage healthcare customers, and drive product demand through strategic account management and clinical dialogue. | Bachelor's degree plus 10+ years in biopharma industry with proven sales success, ability to travel extensively, and knowledge of healthcare regulations and reimbursement. | ABOUT US 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. Strategic Account Manager, Atlanta Location: Remote (Atlanta, Georgia) Do you want to join us in helping to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2? We have an exciting new opportunity for a Strategic Account Manager who will play a pivotal role at Invivyd. This is an incredible opportunity for someone who is passionate about making a difference for patients, executing successful sales strategies and supporting a culture of adaptability and compliance. The Strategic Account Manager will be responsible for the execution of territory business plans and educating on approved messages to a variety of customers. Responsibilities: The Strategic Account Manager is responsible for providing solutions to our customers by acting as a key business owner of Invivyd resources and solutions for a variety of customers, including Health Care Providers, Health Care Organizations, Centers of Excellence, Integrated Delivery Network (IDN) Stakeholders, Veterans Affairs (VA) Centers, Reimbursement Personnel, and Practice Administrators and is accountable for working collaboratively to help ensure customer inquiries are resolved. Facilitate clinical dialogue that compels the customer to act on behalf of their patients and engage the entire account to understand any obstacles that exist to provide appropriate solutions Identify shared priorities and leverage knowledge and tactics within full account to develop a strategic territory business plan that drives product demand by meeting the needs of key partners and ultimately their patients to drive superior results Collaborate with cross-functional partners on overall account and territory strategy to maximize internal/external knowledge on how to access products and services Demonstrates knowledge of the Veterans Affairs (VA) system within territory and the rules and regulations to conduct business within the VA system. Aggregate customer, market data, and insights to effectively apply multiple channels to drive total selling engagements. Utilize data driven approach to prioritize customers/accounts to maximize impact aligned to strategic plan. Requirements: Bachelor’s degree from an accredited college/university. and a minimum of 10 years in the biopharma industry Proven track record of consistent high performance, and well versed in navigating and successfully selling to large accounts and key customer segments Ability to travel up to 100% over a broad geography is required, with the ability to drive and/or fly within the territory Candidate is required to be in the field five days a week, conducting visits, while also completing all administrative tasks related to the role Candidates must live within the stated territory Strong ability to communicate clinical product information Diverse experience in a matrixed environment and exposure to Reimbursement, Buy-and-Bill, Specialty Pharmacies, IDNs, and Federal channels is required Strong understanding and experience with following the laws, regulations, and industry codes (e.g., the PhRMA Code on Interactions with Healthcare Professionals) that govern appropriate interactions with Healthcare Professionals and Healthcare Organizations Must be results oriented and can demonstrate time management skills Possess a broad understanding of case management, market access, reimbursement and selling a medical benefit product Has experience working with Hem/Onc, Rheumatology, Transplant, Hospital/IDN, Veterans Affairs, immunology, account management strategy, and new product launches Demonstrated effective time management, organizational and interpersonal skills to prioritize opportunities Proven winning attitude and experience demonstrated by sales numbers that consistently beat quotas, Presidents Club wins and other awards won At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Invivyd is proud to be an equal opportunity employer. We do not accept unsolicited resumes from agencies.

The Associate Director will develop and lead all quality assurance and compliance activities for the clinical development organization. They will ensure compliance of clinical trials and development activities to global regulatory standards and coordinate audits to support GCP, GLP, GVP, and other regulated activities. | A bachelor’s degree in a scientific discipline or biotechnology field is required, along with a minimum of 6 years of relevant GCP experience in a pharma/biotech company. Candidates should have experience leading inspection readiness activities and managing internal and external audits. | ABOUT US 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. Location: Remote (Northeast preferred) Position summary: The primary responsibility of the Associate Director of Clinical Quality Assurance and Compliance will be to develop and lead all quality assurance and compliance activities for the clinical development organization at Invivyd. The individual will be accountable and responsible for driving Clinical Quality initiatives to completion in conjunction with Invivyd’s Regulatory and Clinical departments and external vendors. This position will also be responsible for coordinating, controlling, and continuously improving the internal quality assurance processes, primarily related to clinical development and related activities and systems. The Associate Director will coordinate audits to support GCP, GLP, GVP, and other regulated activities and lead strategy and activities in support of health authority inspections. The individual will ensure compliance of clinical trials and development activities to global regulatory standards including US FDA, ICH standards, and other international regulatory agencies. They will also be responsible for clinical inspection readiness activities for Invivyd’s development programs. Responsibilities: Build the Clinical Quality Assurance and Compliance function and infrastructure to support Invivyd pipeline and other compliance-related activities Participate on cross-functional team meetings as the Clinical Quality Assurance Subject Matter Expert (SME) Create, implement, and maintain efficient, phase-appropriate, and compliant GCP, GLP, and GVP systems and policies/procedures Partner with other stakeholders across the organization to develop and maintain cross-functional SOPs, policies, procedures, and systems/activities consistent with corporate objectives Stakeholders/partnerships include but are not limited to Clinical Operations, Pharmacovigilance, Regulatory, IT, CMC Quality Assurance, HR, Nonclinical Development Assist the Clinical Development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management Proactively identify potential quality issues/discrepancies and work with Management to effectively resolve in a compliant and timely manner Provide Clinical Quality Support for Clinical Vendor/CRO oversight: Represent Invivyd Clinical Quality on Sponsor/CRO/Site project calls and provide updates to Management Provide Clinical Quality support for critical quality issues, protocol deviations, investigations, root causes, and CAPAs Develop a risk-based audit program to conduct effective audits of internal processes, investigator sites, and vendors that support development activities Establish clinical quality procedures and tools in support of audit and compliance activities Collaborate with key stakeholders in development and implementation of internal and external GCP audit plans Assist in the development, implementation, and maintenance of training and compliance programs: Directly responsible for GCP, GLP, and GVP training and conduct of associated training sessions as required Partner with stakeholders on maintenance and implementation of other training across the organization (i.e., CMC Quality Assurance, IT, HR, Finance, Corporate Compliance, Medical Affairs) to ensure full compliance Proactively provide key stakeholders with intelligence on changes and updates to ICH and GCP regulations and assess impact on Invivyd systems and practices Lead strategy and activities in support of GCP, GLP, and GVP health authority inspections Review regulatory clinical and nonclinical documents such as protocols, clinical study reports, IBs, ICFs, etc. and check for consistency and compliance with relevant regulations, standards, and best practices Competencies: Excellent written and oral communication and organizational skills Ability to communicate complex information in a virtual environment Ability to effectively multi-task and prioritize Ability to work in a cross-functional team collaboratively and independently Ability to flexibly adapt to changing business needs and meet timelines Ability to proactively identify and determine impact of issues on subjects, study conduct, clinical program development, and company needs based on stage of development and risk profile Strong attention to detail and good problem-solving skills Proactive, resourceful, self-starter and team player with a strong result orientation Requirements: A bachelor’s degree in a scientific discipline or biotechnology field A minimum of 6 years relevant GCP experience in pharma/biotech company, working within quality systems and regulated GCP/ICH environments Experience leading and facilitating inspection readiness activities and hosting FDA and other regulatory agency inspections Experience managing internal and external audits Strong understanding of GCPs, FDA, and ICH regulatory standards/guidance documents Extensive knowledge of risk-based quality systems approaches, with a focus on ICH E6 R2 GCP principles Experience using Veeva Quality Vault Ideally will also have experience in facilitating/participating in remote audits and quality activities; able to travel to Clinical sites/vendors as required; Travel Requirement expected to be up to 25%. At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Invivyd is proud to be an equal opportunity employer. We do not accept unsolicited resumes from agencies.

Manage and execute territory business plans, engage healthcare customers including VA centers, drive product demand, and collaborate cross-functionally to support antibody-based therapy sales. | Bachelor's degree, 10+ years biopharma sales experience, extensive travel and field presence, knowledge of VA system and reimbursement channels, strong regulatory compliance, and residency within the NYC territory. | ABOUT US 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. Strategic Account Manager, New York City Location: Remote, New York City metropolitan area, Westchester County. This position will cover the Manhattan borough. Do you want to join us in helping to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2? We have an exciting new opportunity for a Strategic Account Manager who will play a pivotal role at Invivyd. This is an incredible opportunity for someone who is passionate about making a difference for patients, executing successful sales strategies and supporting a culture of adaptability and compliance. The Strategic Account Manager will be responsible for the execution of territory business plans and educating on approved messages to a variety of customers. Responsibilities: The Strategic Account Manager is responsible for providing solutions to our customers by acting as a key business owner of Invivyd resources and solutions for a variety of customers, including Health Care Providers, Health Care Organizations, Centers of Excellence, Integrated Delivery Network (IDN) Stakeholders, Veterans Affairs (VA) Centers, Reimbursement Personnel, and Practice Administrators and is accountable for working collaboratively to help ensure customer inquiries are resolved. Facilitate clinical dialogue that compels the customer to act on behalf of their patients and engage the entire account to understand any obstacles that exist to provide appropriate solutions Identify shared priorities and leverage knowledge and tactics within full account to develop a strategic territory business plan that drives product demand by meeting the needs of key partners and ultimately their patients to drive superior results Collaborate with cross-functional partners on overall account and territory strategy to maximize internal/external knowledge on how to access products and services Demonstrates knowledge of the Veterans Affairs (VA) system within territory and the rules and regulations to conduct business within the VA system. Aggregate customer, market data, and insights to effectively apply multiple channels to drive total selling engagements. Utilize data driven approach to prioritize customers/accounts to maximize impact aligned to strategic plan. Requirements: Bachelor’s degree from an accredited college/university. and a minimum of 10 years in the biopharma industry Proven track record of consistent high performance, and well versed in navigating and successfully selling to large accounts and key customer segments Ability to travel up to 100% over a broad geography is required, with the ability to drive and/or fly within the territory Candidate is required to be in the field five days a week, conducting visits, while also completing all administrative tasks related to the role Candidates must live within the stated territory Strong ability to communicate clinical product information Diverse experience in a matrixed environment and exposure to Reimbursement, Buy-and-Bill, Specialty Pharmacies, IDNs, and Federal channels is required Strong understanding and experience with following the laws, regulations, and industry codes (e.g., the PhRMA Code on Interactions with Healthcare Professionals) that govern appropriate interactions with Healthcare Professionals and Healthcare Organizations Must be results oriented and can demonstrate time management skills Possess a broad understanding of case management, market access, reimbursement and selling a medical benefit product Has experience working with Hem/Onc, Rheumatology, Transplant, Hospital/IDN, Veterans Affairs, immunology, account management strategy, and new product launches Demonstrated effective time management, organizational and interpersonal skills to prioritize opportunities Proven winning attitude and experience demonstrated by sales numbers that consistently beat quotas, Presidents Club wins and other awards won At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. Invivyd is proud to be an equal opportunity employer. We do not accept unsolicited resumes from agencies.