Associate Director of Healthcare Compliance

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

 Scholar Rock is seeking a seasoned compliance professional at the Associate Director (AD) level who thrives in fast-paced settings, brings a proactive, practical approach to compliance, and is driven to make an impact. The AD of Healthcare Compliance will assist the Chief Compliance Officer in driving the development, implementation, oversight, and continuous improvement of Scholar Rock’s healthcare compliance program. This individual will serve as a business partner to all business functions supporting commercial and pipeline products, including medical, clinical, and commercial departments, and will operationalize compliance program processes.  In addition, this role will be responsible for managing various compliance projects that support our commitment to integrity and ethical practices.  As a key leader and resource, the individual must have the appropriate level of business acumen and compliance experience, as well as sound judgment to advise the business on complex compliance processes and compliance related issues. The individual will communicate effectively with all levels of the organization, including sales representatives and executives.

This position reports to the Vice President, Chief Compliance Officer and is located in Cambridge, MA.  The Company has flexibility with hybrid work arrangements.

• Draft and revise compliance policies and procedures, working with relevant functional stakeholders, compliance and legal colleagues, and external partners to ensure compliance with applicable laws, regulations and codes (excluding cGMP, cGCP and other GxP guidelines). This includes tracking policy versions and ensuring that updates are successfully implemented and rolled out.
• Serve as a strategic business partner and provide proactive compliance support to designated business areas, such as commercial operations, sales, marketing, medical affairs, and clinical operations and development departments.
• Stay current on changes in the external global ethics & healthcare compliance business environment and develop and implement policy enhancements to reflect the risks.
• Help to create, design, and deliver creative, engaging, and impactful training materials and programs, utilizing a variety of formats. Ensure training is timely, current, and relevant to employees across the organization based on changes to legal and compliance program guidelines and applicable laws, regulations, and trends.
• Develop and track training metrics and prepare reports showing the performance and on-time completion of training activities.
• Oversee and drive the implementation of a global transparency reporting infrastructure to ensure compliance with U.S. Sunshine/Open Payments, state, and ex-US transparency disclosure laws.
• Oversee the timely and accurate data submissions for U.S. Sunshine/Open Payments, state, and ex-US transparency disclosure laws. Analyze data to identify compliance risks and identify and execute on remedial strategies.
• Support Chief Compliance Officer in the design of the annual auditing and monitoring plan, ensuring milestones are met, communicating progress, and making necessary adjustments. Also responsible for planning and execution of audits within the plan (e.g., HCP payments, email audits) and supporting live and virtual monitoring activities (e.g., field monitoring rides, attending live or virtual speaker programs, monitoring advisory boards).
• Assist with ad-hoc compliance reviews, inquiries, investigations, and corrective/preventative measures as required.
• Manage compliance technology platforms, including training, running reports, end-user support, and implement system changes to support compliance initiatives.
• Assist Chief Compliance Officer with execution of Company’s Compliance Committee meetings, including compilation and communication of meeting materials.
• Ensure processes employed to mitigate compliance risks are operating correctly and efficiently, such as debarment and exclusion screening, HCP engagements & FMV, and speaker bureaus.
• Perform project management responsibilities to deliver key global compliance initiatives, ensure on-time and on-budget delivery.
• Periodic travel within the U.S.

• Bachelor’s Degree Required
• Advanced degree (e.g., JD, MBA) Preferred
• Minimum of 8 years of combined experience in ethics and healthcare compliance in pharmaceuticals/biotech, including in-house experience
• High ethical standards and integrity
• Knowledge of laws, regulations, codes, and guidance applicable to US and global pharmaceutical companies (e.g., Anti-kickback statute, False Claims Act, FDCA, FDA guidance, OIG Compliance Program Guidance, OIG advisory opinions, US and ex-US transparency disclosure laws, and U.S. and ex-US industry codes such as PhRMA or EFPIA)
• Ability to recognize compliance risk and develop workable strategies to mitigate such risk
• Self-starter with demonstrated leadership skills able to exercise sound judgment in balancing risks in ambiguous and complex situations, escalating matters appropriately
• Agile, flexible, and solution-oriented approach, yet firm and strong, when appropriate
• Ability to communicate effectively with all levels of management and employees and consult with key business stakeholders
• Exceptional relationship-building skills; must be a team player and support the Compliance function’s goal of proactive and collaborate relationships with all business functions.
• Expertise analyzing multiple data sets, and ability to expertly identify and summarize data trends for stakeholders
• Experience creating effective training
• Exceedingly detail oriented and organized
• Consummate team player with excellent judgment and interpersonal skills
• Demonstrable experience taking ownership of issues and providing timely, actionable guidance
• Excellent project management skills with the ability to manage multiple priorities simultaneously
• Demonstrated superior ability to identify areas for improvement in controls, systems, and processes and implement effective solutions
• Confidence and professionalism to handle difficult conversations and discretion on sensitive matters
• Ability to work in a fast paced and dynamic work environment supporting a rapidly growing business with a strong work ethic and positive attitude
• Strong presentation, verbal, and written skills.
• Travel approximately 20%
• Able to travel within the US (or internationally as required).
• #Hybrid
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Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.