- Align with your values and grit, and passion for innovative science.
- Leverage your deep knowledge of Legal and Compliance 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.
- Implement, and maintain compliance programs and policies to ensure adherence to applicable laws, regulations, and industry standards.
- Provide expert guidance and advice to internal stakeholders on legal and compliance matters, including risk management, corporate governance, and contractual obligations.
- Conduct regular audits and assessments to identify areas of non-compliance and develop corrective action plans as necessary.
- Collaborate with cross-functional teams to integrate compliance considerations into business operations, product development, and commercial activities.
- Monitor changes in relevant laws, regulations, and industry trends, and proactively recommend adjustments to company policies and practices.
- Manage relationships with external legal counsel, regulatory agencies, and industry organizations to stay informed of best practices and emerging issues.
- Lead investigations into potential compliance violations.
- Develop and deliver comprehensive compliance training programs for employees including policies, procedures, and training materials.
- Collaborate with other members of the Compliance and Legal teams, both proactively and on an as-needed basis, for project-based and operational activities, including policies, procedures, and training materials.
- Serve as a trusted advisor, providing strategic insights and recommendations on legal and compliance matters impacting the business.
- Perform any tasks/duties as assigned by the General Counsel & Compliance Officer.
- Juris Doctor (JD) degree from an accredited law school, strongly preferred.
- Admission to the bar in the relevant jurisdiction, strongly preferred.
- 5+ years of experience in legal and compliance roles within the biotech, pharmaceutical, or healthcare industry. Experience in a start-up rare disease company is a plus.
- Deep understanding of regulatory frameworks governing drug development, clinical trials, and commercialization activities.
- Knowledge of healthcare compliance standards, including the Anti-Kickback Statute, False Claims Act, and PhRMA Code.
- Proven track record of implementing compliance initiatives, driving process improvements, and mitigating risk in a dynamic environment.
- Excellent analytical skills with the ability to interpret complex regulations and apply them to business operations.
- Ability to formulate and align legal strategy and drive for implementation.
- Ability to analyze complex legal issues.
- Effective communication and interpersonal skills, with the ability to build relationships and influence decision-making at all levels of the organization.
- Demonstrated commitment to integrity, ethics, and corporate responsibility.
- Proven ability to deal positively when working within tight time pressures and demanding clients.
- Demonstrated professional and culturally sensitive work ethic.
- Travel up to 15%.
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Director, Legal - Boston, United States - X4 Pharmaceuticals, Inc.
2 weeks ago
Description
Director, Legal & ComplianceReporting to:
Vice President, General Counsel and Compliance Officer
Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.
X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency.
We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders.
We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.
This opportunity will ...Accountabilities and Responsibilities:
Requirements:
Proven Experience, Skills, and Education:
This position is based in Boston, MA, and offers a flexible hybrid work model with a minimum of 2 days/week in the office.
About Us
Pipeline
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, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.
Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new employees must have received their complete doses of the COVID-19 vaccine and one booster unless they have been granted an exemption by X4.
