Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.
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:
The Vice President, Global Program Leader for orelabrutinib will provide strategic leadership and direction for the global development of orelabrutinib in progressive multiple sclerosis (MS). Reporting to the Chief Scientific Officer, this individual will define and drive the integrated global program strategy across R&D, and commercial functions to ensure successful execution of the Phase 3 program and future registrational activities.
The Program Leader will partner closely with a Global Program Manager, who will maintain the integrated program timeline, milestones, and operational execution, ensuring coordination across all functions. Together, they will lead a high-performing cross-functional team ensuring strategic focus, cross-functional coordination, and disciplined progress toward regulatory submission and commercialization of orelabrutinib.
Key Responsibilities:
- Program Vision: Define and lead the global strategy for orelabrutinib in progressive MS, ensuring alignment with corporate objectives and competitive differentiation in the MS landscape.
- Clinical Execution: Provide strategic oversight of the Phase 3 program to ensure quality, efficiency, and regulatory alignment.
- Lifecycle Planning: Develop a long-term plan positioning orelabrutinib for regulatory approval, launch, and potential indication expansion.
- Risk Management: Anticipate and address key development and regulatory risks, ensuring timely mitigation and decision-making
- Development Optimization: Identify and pursue scientific and clinical opportunities to strengthen therapeutic positioning.
- Launch Preparation: Collaborate with commercial and medical affairs teams to inform go-to-market strategies and ensure organizational readiness for regulatory milestones and launch.
- Integrated execution: Drive alignment across clinical, regulatory, medical affairs, commercial, and operations to ensure cohesive execution of the global program plan.
- Program Partnership: Work closely with the Global Program Manager to integrate strategic priorities with operational execution.
- Leadership Engagement: Provide clear, strategic communication to the CSO and executive leadership team, ensuring transparent decision-making and accountability
- Internal Leadership: Champion the orelabrutinib program across the organization to maintain alignment and focus.
- Executive Communication: Deliver concise, strategic updates to senior leadership and the Board of Directors.
- External Advocacy: Represent the program in interactions with global regulatory agencies, investigators, and key opinion leaders to advance program goals.
Qualifications:
- Advanced degree in life sciences (MD, PhD, or PharmD preferred).
- 15+ years of experience in drug development, with significant experience in neurology or immunology.
- Demonstrated success leading late-stage (Phase 3 or registrational) global programs.
- Strong knowledge of regulatory strategy, clinical development, and commercialization planning.
- Exceptional communication, leadership, and cross-functional collaboration skills.
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Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $248,000 to $310,000. 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.
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Zenas BioPharma Waltham, Massachusetts, USA Office
1000 Winter St, Suite 1200,, Waltham, Massachusetts, United States, 02451
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