Sobre esta vaga de Director, Global Compliance na Zenas BioPharma
Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody.
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!
Position Summary:
Zenas BioPharma is looking for a Director of Global Compliance to play a central role in shaping and advancing our global ethics and compliance program as we move toward commercial launch. This is a high-impact, highly visible role that sits at the intersection of compliance, business partnership, and organizational culture.
Reporting to the Executive Director, Global Compliance, you will help design, implement, and mature scalable compliance solutions that support Zenas's growing commercial and medical organizations — ensuring we meet evolving regulatory obligations while fostering a culture of integrity, accountability, and transparency. You will work closely with cross-functional partners across Legal, Medical Affairs, Commercial, Finance, HR, and IT to ensure our compliance program is practical, well-integrated, and fit for purpose.
If you are a collaborative, solutions-oriented compliance professional who thrives in a fast-paced environment and is energized by building programs that matter — this role is for you.
Key Responsibilities:
Program Development & Governance
- Support the build and continuous improvement of Zenas's global ethics and compliance program, ensuring alignment with organizational values, applicable laws, regulations, and industry codes
- Conduct and maintain periodic compliance risk assessments to identify, prioritize, and mitigate emerging risks
- Monitor changes in applicable laws, regulations, and industry guidance and translate them into actionable program updates
Policies & Written Standards
- Draft, implement, and maintain compliance-related policies and procedures, including the effective rollouts across the organization
- Ensure policies are clear, practical, and aligned to the needs of a growing, commercially oriented organization
Training & Education
- Develop and deliver compliance training programs and awareness communications for employees and key stakeholders, with emphasis on field-based roles
Monitoring, Auditing & Risk
- Design and integrate compliance controls into company processes to support effective risk management
- Conduct and oversee routine and risk-based monitoring and auditing of key business activities and related policies
Third-Party Risk Management
- Manage and support third-party due diligence activities, including ongoing oversight of key high-risk vendors
Cross-Functional Partnership
- Serve as a trusted compliance advisor to business partners across Commercial, Medical Affairs, Market Access, and other functions
- Provide independent compliance guidance to help manage and mitigate organizational risk
Qualifications:
- Bachelor's degree required
- 5–8 years of progressive healthcare compliance experience within a pharmaceutical, biotechnology, or medical device organization
- Experience supporting first commercial launch preferredSolid understanding of the elements of an effective compliance program, including DOJ and HHS OIG guidance
- Deep knowledge of US healthcare fraud and abuse laws (Anti-Kickback Statute, False Claims Act), transparency laws and regulations (Sunshine Act), and the PhRMA Code on Interactions with Healthcare Professionals
- Familiarity with anti-bribery and anti-corruption legislation, including the Foreign Corrupt Practices Act (FCPA) and similar global regulations
- Experience with healthcare compliance systems, HCP engagement, transparency reporting, and third-party risk management
- Strong interpersonal and communication skills — clear, concise, and effective in both written and verbal formats across all levels of an organization
- Collaborative and cross-functional by nature; able to build trust and credibility with business partners while maintaining independence
- Solutions-oriented with the ability to analyze complex issues, anticipate risks, and propose practical, innovative compliance solutions with minimal supervisory input
- Comfortable operating in a fast-paced, results-driven environment with a high degree of accountability
- Flexible and adaptable; excited by the opportunity to build and evolve a compliance program alongside a growing, multicultural organization
- High degree of personal, professional, and corporate integrity
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)Ability and willingness to travel up to 25% as needed
#LI-Hybrid
The position is eligible for a competitive compensation and benefits package.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $180,000 to $226,051. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
