X4 Pharmaceuticals
Associate Director, Brand Attorney
X4 Pharmaceuticals, Boston, Massachusetts, us, 02298
Associate Director, Brand Attorney
Reporting to:
VP, General Counsel and Compliance Officer
Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work in 2023 by
The Boston Globe , X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community.
With the April 2024 U.S. approval of our first drug XOLREMDI (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders.
This opportunity will …
Align with your values and grit, and passion for innovative science.
Leverage your deep knowledge of legal matters to support our innovative science and allow you to have a major impact on our mission to support our patients.
Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.
Accountabilities and Responsibilities:
Serve as lead counsel for pharmaceutical brands and clinical product.
Advise clients on issues related to advertising and promotion of pharmaceutical products (including FDA regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, Sunshine Act, Food and Drug Cosmetic Act, Medicaid Best Price, etc.)
Review and approve scientific, disease state and promotional campaigns as well as provide legal counsel on internal product review committee; and provide guidance regarding promotional and non-promotional activities.
Advise various business units on matters related to reimbursement activities, access services, patient support, and assistance programs, including government pricing matters and pricing infrastructure.
Draft and negotiate a variety of contracts, including service agreements, consulting agreements, market research agreements, wholesalers, retail pharmacies, group purchasing organizations and distribution agreements.
Support Compliance and business units with compliance legal advice.
Understand internal customer business requirements and effectively communicate the Company’s risk tolerance to internal customers.
Work closely with others in the Legal and Compliance department, identifying and escalating issues to the General Counsel and in-house attorneys, and assist in their resolution.
Provide legal guidance to the Commercial and Medical Affairs organizations on daily activities and special projects.
Review and approve grants and medical education programs and charitable contributions.
Support X4 in transparency reporting globally.
Train company personnel on all matters governed by federal laws and regulations concerning the pharmaceutical industry.
Provide internal support to the Legal Affairs department and Corporate Compliance Committee with daily global legal and compliance requirements, with a primary focus within North America but may assist with global aspects as required.
Manage internal budgets.
Stay up to date on developments in relevant laws and guidance and relay this information to clients.
Other duties as assigned.
Requirements:
JD degree with at least 8 years of experience in legal and/or compliance in a biopharmaceutical environment or practicing law in a law firm. Experience in a commercial entity is preferred.
Minimum of 5-8 years prior work experience, preferably in the pharmaceutical space.
High-level familiarity with a broad range of risk areas, in particular relating to the commercial practice of a global biopharmaceutical company.
Knowledge of regulations and industry guidance, such as PhRMA Code, Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, transparency laws, EFPIA, UK Anti-Bribery Act and similar laws, regulations, and industry standards.
Excellent interpersonal, communication and written skills, proven ability to work with a wide range of stakeholders.
Strong presentation and training skills and ability to work independently and build strong networks throughout the organization.
Ability to effectively work with and manage a number of vendors supporting the Company’s legal efforts across the world.
Ability to communicate complex legal information to individuals at various levels of the organization.
Maintain the highest ethical standards and respect confidentiality of sensitive matters.
Interact with senior management, employees at all levels, vendors, and customers.
Up to 20% travel may be required.
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity or expression, sexual orientation, disability, veteran status or any other characteristic protected by law.
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Reporting to:
VP, General Counsel and Compliance Officer
Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work in 2023 by
The Boston Globe , X4 is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community.
With the April 2024 U.S. approval of our first drug XOLREMDI (mavorixafor), we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders.
This opportunity will …
Align with your values and grit, and passion for innovative science.
Leverage your deep knowledge of legal matters to support our innovative science and allow you to have a major impact on our mission to support our patients.
Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.
Accountabilities and Responsibilities:
Serve as lead counsel for pharmaceutical brands and clinical product.
Advise clients on issues related to advertising and promotion of pharmaceutical products (including FDA regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, Sunshine Act, Food and Drug Cosmetic Act, Medicaid Best Price, etc.)
Review and approve scientific, disease state and promotional campaigns as well as provide legal counsel on internal product review committee; and provide guidance regarding promotional and non-promotional activities.
Advise various business units on matters related to reimbursement activities, access services, patient support, and assistance programs, including government pricing matters and pricing infrastructure.
Draft and negotiate a variety of contracts, including service agreements, consulting agreements, market research agreements, wholesalers, retail pharmacies, group purchasing organizations and distribution agreements.
Support Compliance and business units with compliance legal advice.
Understand internal customer business requirements and effectively communicate the Company’s risk tolerance to internal customers.
Work closely with others in the Legal and Compliance department, identifying and escalating issues to the General Counsel and in-house attorneys, and assist in their resolution.
Provide legal guidance to the Commercial and Medical Affairs organizations on daily activities and special projects.
Review and approve grants and medical education programs and charitable contributions.
Support X4 in transparency reporting globally.
Train company personnel on all matters governed by federal laws and regulations concerning the pharmaceutical industry.
Provide internal support to the Legal Affairs department and Corporate Compliance Committee with daily global legal and compliance requirements, with a primary focus within North America but may assist with global aspects as required.
Manage internal budgets.
Stay up to date on developments in relevant laws and guidance and relay this information to clients.
Other duties as assigned.
Requirements:
JD degree with at least 8 years of experience in legal and/or compliance in a biopharmaceutical environment or practicing law in a law firm. Experience in a commercial entity is preferred.
Minimum of 5-8 years prior work experience, preferably in the pharmaceutical space.
High-level familiarity with a broad range of risk areas, in particular relating to the commercial practice of a global biopharmaceutical company.
Knowledge of regulations and industry guidance, such as PhRMA Code, Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, transparency laws, EFPIA, UK Anti-Bribery Act and similar laws, regulations, and industry standards.
Excellent interpersonal, communication and written skills, proven ability to work with a wide range of stakeholders.
Strong presentation and training skills and ability to work independently and build strong networks throughout the organization.
Ability to effectively work with and manage a number of vendors supporting the Company’s legal efforts across the world.
Ability to communicate complex legal information to individuals at various levels of the organization.
Maintain the highest ethical standards and respect confidentiality of sensitive matters.
Interact with senior management, employees at all levels, vendors, and customers.
Up to 20% travel may be required.
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity or expression, sexual orientation, disability, veteran status or any other characteristic protected by law.
#J-18808-Ljbffr