Beam Therapeutics
Vice President, Compliance
Cambridge, MA · Exec · Full-time
Sponsorship not specified$310k-$400kDetected 9 days ago
ComplianceBusiness DevelopmentCRISPRAnimal StudiesLeadershipCommunicationProblem Solving
About the role
- Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
- To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
- This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.
Responsibilities
- Provide proactive strategic advice to the business to help drive commercial success and ensure compliance with applicable laws and company policies, including federal and state anti-kickback and false claims laws
- Develop and maintain trusting relationships with key client groups, such as commercial and clinical, and serve as a trusted and strategic advisor and resource.
- Continuously assess the effectiveness of the compliance program through data-driven audits, risk assessments, and performance metrics. Identify gaps and support the design and tracking of corrective actions to strengthen compliance controls.
- Manage and conduct compliance investigations, working with internal business partners to identify appropriate corrective and preventive actions.
- Provide proactive strategic advice to the business to help drive commercial success and ensure compliance with applicable laws and company policies, including federal and state anti-kickback and false claims laws; U.S. and other country anticorruption laws; the federal Food, Drug and Cosmetic Act; and federal and state transparency laws.
Requirements
- Demonstrated effectiveness operating in complex organizational and regulatory environments and experience with Code implementation (PhRMA, EFPIA, IFPMA)
- Proven ability to work with all levels of management.
- Ability to appropriately prioritize issues.
- Relevant experience (typically 7 years or more, or equivalent combination of education, training, and experience) with a deep understanding of compliance issues confronting the pharmaceutical/biotech industry.
- Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the U.S. Sentencing Guidelines.
- Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical industry including sales and marketing, OIG and other industry guidance documents, regulations on the promotion of marketed products, clinical trial regulations, patient privacy and issues arising under the False Claims Act, anti-bribery/anti-corruption laws, and other related laws.
- Business focused and solution oriented.
- Excellent written, oral and presentation skills.
- Strong problem-solving and analytical skills.
- Self-motivated and able to perform role independently, with a minimum level of supervision.
- Demonstrated ability to partner effectively with others in addressing complex issues.
- Strong influencing skills and sound business judgment.
Nice to have
- Bachelor's degree required, Juris Doctorate or advanced degree a plus.
- Cell and gene therapy experience a plus.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
Benefits
- Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Company info
- The Vice President, Compliance is a strategic leader responsible for designing, implementing, and continuously improving the company's Corporate Compliance Program to oversee promotional materials, field training, and HCP/patient programs.
- Beam is transitioning to a commercial stage company, and this position plays a critical role in developing a culture of compliance.
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This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.