Senior Director - Compliance
About Sydnexis: Sydnexis Inc. is a clinical-stage biopharmaceutical company united by a single purpose: helping children see clearly. We are developing a proprietary, stable, topical eye drop designed to slow the progression of myopia, a disease that affects more children today than ever before. Our team has filed a New Drug Application (NDA) with the FDA for our patented formulation, marking an important milestone in redefining the standard of care in pediatric eye health. At our core, we believe every child deserves the chance to see their world, and their future, with clarity. This belief drives us every day. When you join Sydnexis, you become part of a mission bigger than any one of us: to challenge outdated standards, disrupt the status quo, and deliver innovations that truly matter. Here, you’ll find a tight-knit, purpose-driven team building something extraordinary together, and the opportunity to make a lasting impact on children’s lives. Position: As the Senior Director of Compliance, you will play a critical role in supporting the organization’s commitment to ethical business practices and regulatory compliance as we prepare for our first potential commercial launch. This position oversees compliance initiatives related to Fair Market Value (FMV) payments, Transfer of Value reporting, price transparency reporting, auditing and monitoring, investigations, training, and policy development. The role requires collaboration across various functions, including Business Operations, Finance, IT, Contracts, Market Access, and other stakeholders, to ensure adherence to federal, state, and global regulations. Role and Responsibilities:
Oversee the Fair Market Value (FMV) assessment process to ensure that payments to Eyecare professionals (ECPs) comply with regulatory requirements and company policies.
Ensure compliance with state price transparency reporting laws in partnership with Market Access.
Provide compliance oversight for activities such as investigator-initiated trials, sponsorships, grants, and advisory boards.
Implement auditing and monitoring programs to proactively identify and mitigate compliance risks in interactions with ECPs and in commercial activities.
Lead and support internal investigations related to potential compliance violations, ensuring thorough documentation, root cause analysis, and the implementation of corrective actions.
Conduct risk-based compliance assessments to evaluate the effectiveness of policies and controls, and report findings and recommendations to leadership.
Develop and deliver compliance training to employees, ensuring they understand the compliance risks and regulatory obligations specific to the biotechnology industry.
Create and update company compliance policies and procedures in response to changes in the regulatory environment and enforcement landscape.
Provide strategic guidance on emerging healthcare compliance risks, including clinical trials, patient support programs, expanded access programs, and commercialization strategies.
Qualifications:
J.D. degree from an accredited law school.
Over 10 years of work experience, including more than 5 years in compliance or regulatory roles within the biotech, pharmaceutical, or life sciences industries.
Strong knowledge of U.S. and global healthcare compliance regulations, including HIPAA, the Anti-Kickback Statute, the False Claims Act, the Sunshine Act, and state price transparency laws.
Experience with Fair Market Value (FMV) assessments, Transfer of Value (TOV) reporting, price transparency regulations, and industry compliance best practices.
Proven ability to design and deliver compliance training programs.
Strong investigative skills, with experience in auditing, monitoring, and risk management.
Excellent communication, analytical, and interpersonal skills, with the ability to work effectively across functions.
Adaptability and a growth mindset, providing practical compliance solutions to complex challenges.
This position is remote and requires occasional travel for business purposes. Sydnexis Inc. is an Equal Opportunity Employer. We are committed to providing a work environment free of discrimination and harassment. We do not discriminate based on race, color, religion, sex, national origin, age, disability, genetic information, or any other characteristic protected by federal, state, or local law. We are also committed to making our hiring process accessible to individuals with disabilities and will provide reasonable accommodations upon request.
About the job
Apply for this position
Senior Director - Compliance
About Sydnexis: Sydnexis Inc. is a clinical-stage biopharmaceutical company united by a single purpose: helping children see clearly. We are developing a proprietary, stable, topical eye drop designed to slow the progression of myopia, a disease that affects more children today than ever before. Our team has filed a New Drug Application (NDA) with the FDA for our patented formulation, marking an important milestone in redefining the standard of care in pediatric eye health. At our core, we believe every child deserves the chance to see their world, and their future, with clarity. This belief drives us every day. When you join Sydnexis, you become part of a mission bigger than any one of us: to challenge outdated standards, disrupt the status quo, and deliver innovations that truly matter. Here, you’ll find a tight-knit, purpose-driven team building something extraordinary together, and the opportunity to make a lasting impact on children’s lives. Position: As the Senior Director of Compliance, you will play a critical role in supporting the organization’s commitment to ethical business practices and regulatory compliance as we prepare for our first potential commercial launch. This position oversees compliance initiatives related to Fair Market Value (FMV) payments, Transfer of Value reporting, price transparency reporting, auditing and monitoring, investigations, training, and policy development. The role requires collaboration across various functions, including Business Operations, Finance, IT, Contracts, Market Access, and other stakeholders, to ensure adherence to federal, state, and global regulations. Role and Responsibilities:
Oversee the Fair Market Value (FMV) assessment process to ensure that payments to Eyecare professionals (ECPs) comply with regulatory requirements and company policies.
Ensure compliance with state price transparency reporting laws in partnership with Market Access.
Provide compliance oversight for activities such as investigator-initiated trials, sponsorships, grants, and advisory boards.
Implement auditing and monitoring programs to proactively identify and mitigate compliance risks in interactions with ECPs and in commercial activities.
Lead and support internal investigations related to potential compliance violations, ensuring thorough documentation, root cause analysis, and the implementation of corrective actions.
Conduct risk-based compliance assessments to evaluate the effectiveness of policies and controls, and report findings and recommendations to leadership.
Develop and deliver compliance training to employees, ensuring they understand the compliance risks and regulatory obligations specific to the biotechnology industry.
Create and update company compliance policies and procedures in response to changes in the regulatory environment and enforcement landscape.
Provide strategic guidance on emerging healthcare compliance risks, including clinical trials, patient support programs, expanded access programs, and commercialization strategies.
Qualifications:
J.D. degree from an accredited law school.
Over 10 years of work experience, including more than 5 years in compliance or regulatory roles within the biotech, pharmaceutical, or life sciences industries.
Strong knowledge of U.S. and global healthcare compliance regulations, including HIPAA, the Anti-Kickback Statute, the False Claims Act, the Sunshine Act, and state price transparency laws.
Experience with Fair Market Value (FMV) assessments, Transfer of Value (TOV) reporting, price transparency regulations, and industry compliance best practices.
Proven ability to design and deliver compliance training programs.
Strong investigative skills, with experience in auditing, monitoring, and risk management.
Excellent communication, analytical, and interpersonal skills, with the ability to work effectively across functions.
Adaptability and a growth mindset, providing practical compliance solutions to complex challenges.
This position is remote and requires occasional travel for business purposes. Sydnexis Inc. is an Equal Opportunity Employer. We are committed to providing a work environment free of discrimination and harassment. We do not discriminate based on race, color, religion, sex, national origin, age, disability, genetic information, or any other characteristic protected by federal, state, or local law. We are also committed to making our hiring process accessible to individuals with disabilities and will provide reasonable accommodations upon request.