Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Director, US Compliance

$204k - $280.5k

Dormont Manufacturing Company

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. Arggenx is preparing for multi‑dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first‑in‑class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science‑based start‑up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Director of US Compliance is a key member of our Compliance team who will support our US Compliance program and be based in Boston, MA . This individual will help support the Head of US Compliance to further develop a best‑in‑class compliance program in the U.S. This dynamic team is poised for growth, with cross‑functional work with teams in Europe and Asia. The Director of US Compliance will support the effort to develop policies and other written standards, develop training materials, execute auditing and monitoring activities, and manage other general compliance activities, including fostering the strong ethical culture of Arggenx. Roles and Responsibilities: Partner with key business stakeholders to provide guidance and advice regarding compliance obligations, relevant regulations, and areas of potential business opportunity. Evolve and align the global compliance program to ensure that it is consistent with the values and principles of the organization, fit for purpose and complies with applicable legal and regulatory requirements. Support the US commercial and medical teams to provide compliance‑based input and direction across product portfolio. Draft and implement appropriate policies, in collaboration with the Head of US Compliance, legal and other compliance colleagues, to ensure compliance with applicable laws, regulations and codes applicable in the US (excluding cGMP, cGCP and other GxP guidelines). Support routine and risk‑based monitoring and auditing of relevant US business activities and related policies and procedures; assist in and oversee the implementation of corrective action plans as necessary; and generate and deliver reports to leadership on monitoring, auditing and risk assessment. Conduct or assist in compliance‑related investigations and other allegations of misconduct, as required. Prepare and deliver compliance training and education to the US organization, with particular emphasis on field‑based employees, to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures. Support onboarding and cross training of other US Compliance team members. Support content development, presentation delivery and training for the US Compliance Committee. Other duties as assigned. Skills and Competencies: Strong interpersonal and oral and written communication skills; a collaborator who communicates in an open, clear, complete, timely and consistent manner. Shows flexibility and is open to change in a growing, multi‑cultural environment; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the company’s business and culture. Team‑player, able to work well with others and communicate with cross‑functional colleagues. Able to innovate, analyze and solve problems with minimal supervisory input, anticipating and identifying compliance and other business risks; capable of strategic thinking and proposing innovative solutions to compliance‑related challenges. Solid understanding of business goals and legal, compliance and regulatory landscape in the US. High degree of personal, professional and corporate ethics, integrity and responsibility. Knowledge of and proficiency with laws and regulations applicable to global pharmaceutical companies, including among other things, the US Foreign Corrupt Practices Act, US fraud and abuse and false claims laws and PhRMA Code on Interactions with Healthcare Professionals. Comfortable in a results‑driven, highly accountable environment where you can make a clear impact; consistently shows initiative, and willing and able to take high levels of responsibility for complex initiatives. Education, Experience and Qualifications: A minimum of 5-8 years of biopharmaceutical industry experience in a relevant compliance function, with extensive experience within a commercial stage pharmaceutical or biotech company. BA/BS required. Experience with launching new products and/or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals and transparency are all essential. Expertise in the areas of US corporate commercial healthcare law and regulation, including with respect to healthcare fraud and abuse laws, US transparency laws and regulations, privacy laws, anti‑bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products. Expertise in the PhRMA Code on Interactions with Healthcare Professionals and other relevant industry codes and guidelines. Travel 15-20% Seeking candidates local to MA #LI-hybrid For applicants in the United States: The annual base salary hiring range for this position is $204,000.00 - $280,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job‑related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks. This job is eligible to participate in our short‑term and long‑term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines. At Arggenx, all applicants are welcomed in an inclusive environment. They 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. Arggenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our Arggenx Privacy Notice for Job Applicants to learn more about how Arggenx B.V. and its affiliates (“Arggenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at View email address on click.appcast.io. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at View email address on click.appcast.io. Only inquiries related to an accommodation request will receive a response. #J-18808-Ljbffr

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Director, US Compliance in Boston, MA vacancy
  • $204k - $280.5k

     ...Overview Director of US Compliance will support the Head of US Compliance in developing a best‑in‑class compliance program. Based in Boston, MA, the role works with cross‑functional teams in Europe and Asia to foster a strong ethical culture across argenx. Key Responsibilities... 
    Suggested
    Temporary work
    Local area

    argenx SE

    Boston, MA
    7 hours ago
  • Servier Pharmaceuticals is seeking an Associate Director for US Ethics & Compliance based in Boston. This role involves developing innovative compliance training programs to promote ethical decision-making within the organization. The ideal candidate will have over 7 years... 
    Suggested
    Work at office

    Servier Pharmaceuticals

    Boston, MA
    5 days ago
  • AstraZeneca GmbH in Boston, MA is seeking a Director, US Advertising and Promotional Compliance to lead the therapeutic area regulatory effort for assigned products. You will review and approve promotional materials and disease awareness communications, ensuring compliance... 
    Suggested

    AstraZeneca

    Boston, MA
    4 days ago
  • $204k - $280.5k

    argenx SE is seeking a Director of US Compliance in Boston, MA to develop a robust compliance program while supporting the Head of US Compliance. The role emphasizes collaboration across global teams to ensure ethical practices within the organization. Ideal candidates... 
    Suggested

    argenx SE

    Boston, MA
    4 days ago
  • We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology... 
    Suggested

    VCLS

    Boston, MA
    4 days ago
  • Sanofi, located in Cambridge, MA, is seeking a Director of US Regulatory Affairs for Advertising & Promotion. This hybrid role involves ensuring compliance with regulations, offering mentorship, and leading team strategies without direct reports. The ideal candidate has... 

    Sanofi

    Cambridge, MA
    1 day ago
  • VCLS, a regulatory consulting firm, seeks an experienced Senior Director or Executive Director of US Regulatory Strategy in Boston to provide strategic regulatory guidance to biotech and pharma clients developing innovative therapies. Lead US/global regulatory strategy... 

    VCLS

    Boston, MA
    4 days ago
  • $178.5k - $257.83k

    Director, US Regulatory Affairs - Advertising & Promotion (Hybrid) Location: Cambridge, MA; Morristown, NJ About the Job: Shape the future of medicine by ensuring all U.S. advertising and promotional materials comply with regulations, company policy and industry guidelines... 

    Sanofi

    Cambridge, MA
    1 day ago
  • $196k - $270k

    About This Role As a Compliance Officer, you will uphold and promote ethical integrity within Biogen's US business. Your expertise will ensure that our business operations adhere to the highest standards of compliance and regulatory conduct. By developing and delivering... 
    Temporary work
    Work at office
    Local area

    Biogen, Inc.

    Cambridge, MA
    5 days ago
  • Bicara Therapeutics is seeking a Senior Director of Regulatory Affairs in Boston. This role will lead US regulatory strategy for the biologics pipeline, overseeing regulatory submissions and health authority interactions. The ideal candidate will have 10-12 years of experience... 
    Work at office
    3 days per week

    Bicara Therapeutics

    Boston, MA
    4 days ago
  • $193.28k - $289.92k

    AstraZeneca is looking for a Director of US Advertising and Promotional Compliance in Boston, Massachusetts. This role is pivotal in reviewing promotional materials, advising product development teams, and ensuring adherence to FDA regulations. The ideal candidate will... 

    AstraZeneca

    Boston, MA
    22 hours ago
  • $260k - $296k

    A prominent biopharmaceutical company located in California seeks an Executive Director, US Value & Access to define and advance U.S. payer access strategies. The ideal candidate will have extensive experience in U.S. Market Access, leading payer strategies, and managing... 

    Ionis Pharmaceuticals, Inc.

    Boston, MA
    3 days ago
  • $154.4k - $242.55k

    Initial Therapeutics, Inc. is seeking an Associate Director, Global and US Pipeline Forecasting Lead in Boston, MA. This role will drive the forecast strategy for key pipeline assets and lead collaboration across Marketing, Medical, and Access teams. Candidates should have... 

    Initial Therapeutics, Inc.

    Boston, MA
    1 day ago
  • $150.1k - $225.15k

    This is what you will do: The Associate Director Strategic Planning & Execution, US Medical Affairs is responsible for the execution of strategic initiatives...  ...with a focus on continuous improvement Liaise with Compliance and Legal to resolve questions and mitigate risk... 
    Contract work
    Temporary work
    Work at office

    AstraZeneca GmbH

    Boston, MA
    3 days ago
  • $139.12k - $208.68k

     ...Digital and E-commerce, Technology and more. Overview Manage the team driving strategy development at ADUSA to further activate the US growth ambition and global Growing Together strategy. Establish & support the US' top strategic priorities and the programs within them... 
    Full time
    Work at office
    Remote work
    Flexible hours

    ViziRecruiter,LLC.

    Quincy, MA
    5 days ago
  • $192.4k - $302.39k

    Takeda is seeking a Director within the US Medical Affairs team in Cambridge, MA. This critical role requires an advanced degree and at least four years of industry experience. You will develop product-specific medical strategies, serve as a Subject Matter Expert, and... 

    Takeda

    Cambridge, MA
    1 day ago
  • Sanofi is seeking a Senior Director for US Rare Disease Value and Access in Cambridge, MA. This role involves owning payer-focused access strategy across a $2.2B business, leading pricing, contracting, and reimbursement strategies, and maximizing patient access. The ideal... 

    Sanofi

    Cambridge, MA
    4 days ago
  • AstraZeneca is seeking an Associate Director in Boston for US Medical Affairs, responsible for executing strategic initiatives and ensuring alignment...  ...industry and possess strong project management and compliance knowledge. Competitive compensation includes a base salary... 

    AstraZeneca

    Boston, MA
    4 days ago
  • $170k - $190k

    Job Overview HarbourVest is seeking a Director in the Tax Compliance function with primary responsibility for management company tax compliance. The...  ...processes, including income tax provisions and ASC 740 review, US federal/state and non‑US filings, and global tax... 
    Work at office
    Remote work

    Harbourvest Partners (U.K.) Limited

    Boston, MA
    4 days ago
  • $260k - $296k

     ...history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact...  ...culture while you develop and expand your career! EXECUTIVE DIRECTOR, US VALUE & ACCESS SUMMARY The Executive Director, Value &... 
    Remote work
    Shift work

    Ionis Pharmaceuticals, Inc.

    Boston, MA
    3 days ago
  • $196k - $294k

     ...strategic and collaborative leader to join the US Pain Business Unit to support our journey...  ...options for the treatment of pain. The Director, Key Thought Leader (KTL) Strategy &...  ...external partnerships. Familiarity with compliance requirements related to external engagement... 
    Remote work
    2 days per week

    Vertex US Distribution

    Boston, MA
    3 days ago
  • $164k - $226k

    The Associate Director of Strategy and Operations plays a critical role in ensuring the US Market Access & Reimbursement (MA&R) organization is positioned to deliver on its strategy and business priorities by driving alignment, preparedness, and operational discipline.... 
    Temporary work
    Local area

    Biogen, Inc.

    Cambridge, MA
    1 day ago
  •  ...preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international...  ...submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies... 
    Work at office

    Monte Rosa Therapeutics Inc.

    Boston, MA
    7 hours ago
  • $192.4k - $302.39k

     ...that all information I submit in my employment application is true to the best of my knowledge. OBJECTIVE: The Director is a critical role within the US Medical Affairs (USMA) organization that reports to the Vice President. The role has tactical accountability grounded... 
    Minimum wage
    Full time
    Temporary work
    Local area

    Initial Therapeutics, Inc.

    Cambridge, MA
    2 days ago
  • $193.28k - $289.92k

    The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving the regulatory content of materials created for product... 
    Temporary work
    Work at office

    AstraZeneca GmbH

    Boston, MA
    4 days ago
  • $273.9k - $331.91k

    ## Senior Director, External innovation, NeuroscienceCambridge Crossing - MA - USFind out how well you match with this job**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers... 
    Hourly pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb

    Cambridge, MA
    3 days ago
  • $196k - $294k

    Vertex Pharmaceuticals in Boston seeks a Director for USMA Payer Contract Operations to lead the end-to-end contracting lifecycle. This position...  ...strong negotiation skills and a deep understanding of the US payer landscape. The role offers a hybrid work option,... 
    Contract work

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • $206.25k - $297.92k

    Job Title Senior Director, US Rare Disease Value and Access Location Cambridge, MA Overview Join the team transforming care for people...  ...in regulatory and reimbursement landscape; ensure sustained compliance and access. Develop primary payer research and advisory board... 

    Sanofi

    Cambridge, MA
    4 days ago
  • Initial Therapeutics, Inc. is seeking a Director to join the US Medical Affairs team in Cambridge, MA. This pivotal role involves strategic oversight of medical initiatives, collaboration with cross-functional partners, and the execution of product-specific medical strategies... 

    Initial Therapeutics, Inc.

    Cambridge, MA
    2 days ago
  • $100k - $231.54k

     ...accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger - helping to simplify health...  ...responsible for partnering with and leading engagement across Compliance and Regulatory Affairs to understand specific compliance... 
    Work experience placement
    Work at office
    Local area

    Hispanic Alliance for Career Enhancement

    Boston, MA
    5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, US Compliance. Be the first to apply!