VP, Compliance

Company Overview

Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in severe liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey.   Position Summary:

The VP, Compliance, will be responsible for driving the development, implementation, oversight, and continuous improvement of Boston Pharmaceutical’s research & development compliance program. This individual will serve as a business partner to all products and business functions, including medical, clinical, and regulatory, and will operationalize compliance processes based on the needs of the organization. As a member of the extended leadership team, the incumbent must have the appropriate level of business acumen and leadership experience to partner across all levels of the organization while remaining a hands-on team player who is willing to personally manage and integrate the research & development compliance program and consult on corporate compliance as needed.

Roles & Responsibilities:

• Maintain effective lines of communication with the business about compliance by generating awareness of compliance-related issues, policies and procedures, and new compliance developments; ensure constant and easy access to compliance policies, forms and process information
• Lead compliance risk assessments and create and execute plans to mitigate identified risks
• Serve as a strategic business partner and provide proactive compliance support to designated business areas, such as medical affairs and clinical operations and development departments
• Oversee development, creation, and execution of employee and consultant/vendor compliance training materials and curricula
• Assist with compliance investigations, as necessary
• Draft, revise, and ensure version control for compliance policies and procedures to ensure compliance with applicable laws, regulations and codes
• Assist with compilation and communication of materials presented at leadership team and Board of Directors meetings
• Ensure processes employed to mitigate compliance risks are operating correctly and efficiently
• Stay abreast of industry law changes and inform business of the same; participate in various Legal & Compliance Department projects and initiatives as needed
• Partner with Legal to advise on corporate compliance as needed
• Act as a member of Boston Pharmaceuticals’ extended leadership team; work collaboratively with other senior leaders to achieve corporate objectives and initiatives

Qualifications:

• Advanced degree (e.g., JD, MBA) preferred
• 12 years of ethics, compliance or a mix of compliance and legal experience in an organization subject to global biopharmaceutical or other relevant healthcare compliance laws and regulations
• Deep understanding of the drug development process, including how compliance requirements evolve from early to late-stage clinical trials
• Experience managing a team of compliance professionals, including external teams through vendor
• Expertise analyzing multiple data sets, and ability to expertly identify and summarize trends
• Experience working with all levels of management and consulting with key business stakeholders
• Experience creating effective training programs
• Some global R&D compliance experience preferred
• Expert knowledge of laws and regulations applicable to global pharmaceutical companies; solid working knowledge of other laws, regulations, and industry standards
• Exceedingly detail oriented and organized
• Ability to handle difficult situations with firmness and care
• High ethical standards and integrity
• Ability to communicate effectively with all levels of management and employees
• Strong collaboration skills; ability to build effective relationships internally and externally
• Self-starter with demonstrated leadership skills and ability to meet goals given limited supervision; able to exercise sound judgment in balancing risks in ambiguous and complex situations and escalating matters appropriately
• Confidence and professionalism to handle difficult conversations and discretion on sensitive matters
• Embraces and embodies Boston Pharmaceuticals’ corporate values: Commitment to Patients, Decisive Innovation, Purposeful Urgency, Passion for Excellence, One Team