Zenas BioPharma
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Director, Investor Relations
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 seeking an accomplished Director of Investor Relations to lead the development and execution of comprehensive IR strategies that effectively communicates the company’s scientific platform, clinical progress, regulatory milestones, and financial outlook to the investment community. Reporting to the Chief Financial Officer, this leader will work closely with executive management, R&D, new product planning, and cross functional partners to deliver consistent, compliant, and high impact communications. The role is central to gaining internal alignment and shaping external perception of Zenas’ transparency, credibility, and long term value creation.
Key Responsibilities:
- Develop high quality investor-facing materials including earnings documents, presentations, press releases, fact sheets, and Q&A; translating complex scientific and clinical concepts into clear, accessible content.
- Build and maintain strong relationships with covering analysts, ensuring their research and perspectives remain aligned with company messaging and strategic objectives.
- Collaborate cross functionally to craft compelling written materials that support company positioning and effectively communicate program updates during conference calls, investor meetings, and analyst events.
- Partner closely with Finance, Legal, Corporate Communications and external advisors to ensure accuracy, consistency, and regulatory compliance across all investor communications.
- Synthesize investor feedback, analyst commentary, and broader market sentiment to deliver actionable insights and recommendations to senior leadership.
- Coordinate logistics and prepare briefing materials for investor and analyst meetings, conference participation, and other external engagements.
- Manage a high impact IR events calendar including roadshows, medical and investor conferences, R&D days, and quarterly updates ensuring timely, accurate execution of all deliverables.
- Maintain detailed records of investor interactions, feedback, and follow ups to inform leadership and refine the overall IR strategy.
Qualifications:
- Bachelor’s degree in a scientific field; advanced degree (MD, PharmD, PhD) preferred.
- 5+ years of relevant experience in investor relations, equity research, investment banking, corporate finance, or related roles within biotechnology or the life sciences; experience in a publicly traded biotech company strongly preferred.
- Exceptional written and verbal communication skills, with the ability to translate complex scientific, clinical and financial concepts into clear, compelling investor messaging.
- Demonstrated experience preparing and reviewing executive- and external-facing materials.
- Proven ability to work closely with senior executives, including supporting leadership at investor conferences (virtual and in person) and leading preparation for investor events.
- Strong ability to set and manage priorities, deadlines, resources, and cross-functional project initiatives.
- Advanced proficiency in Excel and PowerPoint
- Medical or scientific communications/writing experience is an advantage.
#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 $188,000 to $235,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Regional Business Director, (West Region), Immunology
Share this job
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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Regional Business Director (RBD), Immunology, is a critical commercial leadership role responsible for driving sales performance, strategic execution, and customer engagement across a defined geographic region. This includes the design and implementation of business plans based upon strategic business analysis. This leader will manage, coach, and develop a team of high-performing Account Managers (AMs) to ensure exceptional performance in a competitive rare disease, specialty market. The RBD will collaborate cross-functionally to optimize field strategy, enhance customer experience, and support successful launches within the immunology portfolio. This position reports to the SVP, US Commercial Engagement and Access.
Key Responsibilities:
Regional Leadership & Team Management
- Hire, lead, develop, and inspire a team of Account Managers to achieve and exceed regional sales goals.
- Establish a high-performance culture focused on accountability, integrity, strategic execution, and professional development.
- Develop and implement performance plans to support AM skill growth, capability building, and succession planning.
- Conduct regular field rides and coaching sessions to model best practices and reinforce customer-centric engagement.
- Ensure compliance with all company policies, legal requirements, and industry standards in all field activities
Strategic Planning & Execution
- Translate national brand strategy into actionable regional business plans tailored to local markets, customer needs, and competitive dynamics.
- Leverage market data, customer insights, and analytics to identify opportunities and challenges and adjust strategies accordingly.
- Oversee pull-through of brand initiatives, launch plans, and disease-area priorities across the region.
- Partner with Marketing, Market Access, Medical Affairs and other internal stakeholders to ensure aligned compliant execution.
Customer & Market Engagement
- Establish and maintain relationships with key customers, including HCPs, administrators, and influential institutions across immunology.
- Support AMs in developing deeper customer insights and effective territory plans.
- Ensure customer needs and marketplace dynamics are communicated to inform strategy, planning, and resource allocation.
Cross-Functional Collaboration
- Collaborate closely with Medical Affairs, Market Access, Patient Services, and other functions to ensure coordinated, compliant customer engagement.
- Work with leadership to support congress activities, regional events, and speaker programs.
- Ensure alignment between regional goals and national commercial priorities.
Operational Excellence
- Manage regional budget effectively, including resource allocation, travel, and strategic investments.
- Report regional performance trends, strategic recommendations, and competitive insights to senior leadership.
Qualifications:
- Bachelor’s degree required; MBA or advanced degree preferred.
- 8+ years of pharmaceutical/biotech commercial experience, with a minimum of 3–5 years leading field sales teams.
- Experience in rheumatology, immunology, rare disease, biologics, or specialty care strongly preferred.
- Demonstrated success in building, managing, and leading dynamic teams, including performance planning and skill development.
- Proven track record of strong sales performance in highly competitive specialty markets.
- Strong understanding of payer dynamics, specialty pharmacy distribution models, and access challenges in immunology/biologics.
- Excellent strategic thinking, business planning, and analytical skills.
- Exceptional communication, coaching, and interpersonal leadership abilities.
- Ability to travel extensively across the region.
- Talent Developer: Proven ability to coach, elevate, and retain high-potential talent.
- Strategic Operator: Strong business acumen with the ability to translate insights into actionable strategies.
- Cross-Functional Influencer: Effective at aligning multiple internal stakeholders toward shared objectives.
- Customer-Focused Leader: Deep commitment to understanding and addressing customer needs in immunology.
- Integrity & Compliance: Models ethical behavior and ensures compliant execution across the region.
- The preferred candidate will reside in the Los Angeles or San Francisco area
#LI-Remote
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 $187,200 to $234,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Regional Business Director, (Southeast Region), Immunology
Share this job
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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Regional Business Director (RBD), Immunology, is a critical commercial leadership role responsible for driving sales performance, strategic execution, and customer engagement across a defined geographic region. This includes the design and implementation of business plans based upon strategic business analysis. This leader will manage, coach, and develop a team of high-performing Account Managers (AMs) to ensure exceptional performance in a competitive rare disease, specialty market. The RBD will collaborate cross-functionally to optimize field strategy, enhance customer experience, and support successful launches within the immunology portfolio. This position reports to the SVP, US Commercial Engagement and Access.
Key Responsibilities:
Regional Leadership & Team Management
- Hire, lead, develop, and inspire a team of Account Managers to achieve and exceed regional sales goals.
- Establish a high-performance culture focused on accountability, integrity, strategic execution, and professional development.
- Develop and implement performance plans to support AM skill growth, capability building, and succession planning.
- Conduct regular field rides and coaching sessions to model best practices and reinforce customer-centric engagement.
- Ensure compliance with all company policies, legal requirements, and industry standards in all field activities
Strategic Planning & Execution
- Translate national brand strategy into actionable regional business plans tailored to local markets, customer needs, and competitive dynamics.
- Leverage market data, customer insights, and analytics to identify opportunities and challenges and adjust strategies accordingly.
- Oversee pull-through of brand initiatives, launch plans, and disease-area priorities across the region.
- Partner with Marketing, Market Access, Medical Affairs and other internal stakeholders to ensure aligned compliant execution.
Customer & Market Engagement
- Establish and maintain relationships with key customers, including HCPs, administrators, and influential institutions across immunology.
- Support AMs in developing deeper customer insights and effective territory plans.
- Ensure customer needs and marketplace dynamics are communicated to inform strategy, planning, and resource allocation.
Cross-Functional Collaboration
- Collaborate closely with Medical Affairs, Market Access, Patient Services, and other functions to ensure coordinated, compliant customer engagement.
- Work with leadership to support congress activities, regional events, and speaker programs.
- Ensure alignment between regional goals and national commercial priorities.
Operational Excellence
- Manage regional budget effectively, including resource allocation, travel, and strategic investments.
- Report regional performance trends, strategic recommendations, and competitive insights to senior leadership.
Qualifications:
- Bachelor’s degree required; MBA or advanced degree preferred.
- 8+ years of pharmaceutical/biotech commercial experience, with a minimum of 3–5 years leading field sales teams.
- Experience in rheumatology, immunology, rare disease, biologics, or specialty care strongly preferred.
- Demonstrated success in building, managing, and leading dynamic teams, including performance planning and skill development.
- Proven track record of strong sales performance in highly competitive specialty markets.
- Strong understanding of payer dynamics, specialty pharmacy distribution models, and access challenges in immunology/biologics.
- Excellent strategic thinking, business planning, and analytical skills.
- Exceptional communication, coaching, and interpersonal leadership abilities.
- Ability to travel extensively across the region.
- Talent Developer: Proven ability to coach, elevate, and retain high-potential talent.
- Strategic Operator: Strong business acumen with the ability to translate insights into actionable strategies.
- Cross-Functional Influencer: Effective at aligning multiple internal stakeholders toward shared objectives.
- Customer-Focused Leader: Deep commitment to understanding and addressing customer needs in immunology.
- Integrity & Compliance: Models ethical behavior and ensures compliant execution across the region.
- The preferred candidate will reside in the Atlanta, Tampa or Miami area
#LI-Remote
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 $187,200 to $234,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Regional Business Director, (South Central Region), Immunology
Share this job
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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Regional Business Director (RBD), Immunology, is a critical commercial leadership role responsible for driving sales performance, strategic execution, and customer engagement across a defined geographic region. This includes the design and implementation of business plans based upon strategic business analysis. This leader will manage, coach, and develop a team of high-performing Account Managers (AMs) to ensure exceptional performance in a competitive rare disease, specialty market. The RBD will collaborate cross-functionally to optimize field strategy, enhance customer experience, and support successful launches within the immunology portfolio. This position reports to the SVP, US Commercial Engagement and Access.
Key Responsibilities:
Regional Leadership & Team Management
- Hire, lead, develop, and inspire a team of Account Managers to achieve and exceed regional sales goals.
- Establish a high-performance culture focused on accountability, integrity, strategic execution, and professional development.
- Develop and implement performance plans to support AM skill growth, capability building, and succession planning.
- Conduct regular field rides and coaching sessions to model best practices and reinforce customer-centric engagement.
- Ensure compliance with all company policies, legal requirements, and industry standards in all field activities
Strategic Planning & Execution
- Translate national brand strategy into actionable regional business plans tailored to local markets, customer needs, and competitive dynamics.
- Leverage market data, customer insights, and analytics to identify opportunities and challenges and adjust strategies accordingly.
- Oversee pull-through of brand initiatives, launch plans, and disease-area priorities across the region.
- Partner with Marketing, Market Access, Medical Affairs and other internal stakeholders to ensure aligned compliant execution.
Customer & Market Engagement
- Establish and maintain relationships with key customers, including HCPs, administrators, and influential institutions across immunology.
- Support AMs in developing deeper customer insights and effective territory plans.
- Ensure customer needs and marketplace dynamics are communicated to inform strategy, planning, and resource allocation.
Cross-Functional Collaboration
- Collaborate closely with Medical Affairs, Market Access, Patient Services, and other functions to ensure coordinated, compliant customer engagement.
- Work with leadership to support congress activities, regional events, and speaker programs.
- Ensure alignment between regional goals and national commercial priorities.
Operational Excellence
- Manage regional budget effectively, including resource allocation, travel, and strategic investments.
- Report regional performance trends, strategic recommendations, and competitive insights to senior leadership.
Qualifications:
- Bachelor’s degree required; MBA or advanced degree preferred.
- 8+ years of pharmaceutical/biotech commercial experience, with a minimum of 3–5 years leading field sales teams.
- Experience in rheumatology, immunology, rare disease, biologics, or specialty care strongly preferred.
- Demonstrated success in building, managing, and leading dynamic teams, including performance planning and skill development.
- Proven track record of strong sales performance in highly competitive specialty markets.
- Strong understanding of payer dynamics, specialty pharmacy distribution models, and access challenges in immunology/biologics.
- Excellent strategic thinking, business planning, and analytical skills.
- Exceptional communication, coaching, and interpersonal leadership abilities.
- Ability to travel extensively across the region.
- Talent Developer: Proven ability to coach, elevate, and retain high-potential talent.
- Strategic Operator: Strong business acumen with the ability to translate insights into actionable strategies.
- Cross-Functional Influencer: Effective at aligning multiple internal stakeholders toward shared objectives.
- Customer-Focused Leader: Deep commitment to understanding and addressing customer needs in immunology.
- Integrity & Compliance: Models ethical behavior and ensures compliant execution across the region.
- The preferred candidate will reside in the Dallas or Houston area
LI-Remote
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 $187,200 to $234,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Regional Business Director, (Northeast Region), Immunology
Share this job
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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Regional Business Director (RBD), Immunology, is a critical commercial leadership role responsible for driving sales performance, strategic execution, and customer engagement across a defined geographic region. This includes the design and implementation of business plans based upon strategic business analysis. This leader will manage, coach, and develop a team of high-performing Account Managers (AMs) to ensure exceptional performance in a competitive rare disease, specialty market. The RBD will collaborate cross-functionally to optimize field strategy, enhance customer experience, and support successful launches within the immunology portfolio. This position reports to the SVP, US Commercial Engagement and Access.
Key Responsibilities:
Regional Leadership & Team Management
- Hire, lead, develop, and inspire a team of Account Managers to achieve and exceed regional sales goals.
- Establish a high-performance culture focused on accountability, integrity, strategic execution, and professional development.
- Develop and implement performance plans to support AM skill growth, capability building, and succession planning.
- Conduct regular field rides and coaching sessions to model best practices and reinforce customer-centric engagement.
- Ensure compliance with all company policies, legal requirements, and industry standards in all field activities
Strategic Planning & Execution
- Translate national brand strategy into actionable regional business plans tailored to local markets, customer needs, and competitive dynamics.
- Leverage market data, customer insights, and analytics to identify opportunities and challenges and adjust strategies accordingly.
- Oversee pull-through of brand initiatives, launch plans, and disease-area priorities across the region.
- Partner with Marketing, Market Access, Medical Affairs and other internal stakeholders to ensure aligned compliant execution.
Customer & Market Engagement
- Establish and maintain relationships with key customers, including HCPs, administrators, and influential institutions across immunology.
- Support AMs in developing deeper customer insights and effective territory plans.
- Ensure customer needs and marketplace dynamics are communicated to inform strategy, planning, and resource allocation.
Cross-Functional Collaboration
- Collaborate closely with Medical Affairs, Market Access, Patient Services, and other functions to ensure coordinated, compliant customer engagement.
- Work with leadership to support congress activities, regional events, and speaker programs.
- Ensure alignment between regional goals and national commercial priorities.
Operational Excellence
- Manage regional budget effectively, including resource allocation, travel, and strategic investments.
- Report regional performance trends, strategic recommendations, and competitive insights to senior leadership.
Qualifications:
- Bachelor’s degree required; MBA or advanced degree preferred.
- 8+ years of pharmaceutical/biotech commercial experience, with a minimum of 3–5 years leading field sales teams.
- Experience in rheumatology, immunology, rare disease, biologics, or specialty care strongly preferred.
- Demonstrated success in building, managing, and leading dynamic teams, including performance planning and skill development.
- Proven track record of strong sales performance in highly competitive specialty markets.
- Strong understanding of payer dynamics, specialty pharmacy distribution models, and access challenges in immunology/biologics.
- Excellent strategic thinking, business planning, and analytical skills.
- Exceptional communication, coaching, and interpersonal leadership abilities.
- Ability to travel extensively across the region.
- Talent Developer: Proven ability to coach, elevate, and retain high-potential talent.
- Strategic Operator: Strong business acumen with the ability to translate insights into actionable strategies.
- Cross-Functional Influencer: Effective at aligning multiple internal stakeholders toward shared objectives.
- Customer-Focused Leader: Deep commitment to understanding and addressing customer needs in immunology.
- Integrity & Compliance: Models ethical behavior and ensures compliant execution across the region.
- The preferred candidate will reside in the Boston, New York or Philly area
LI-Remote
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 $187,200 to $234,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Regional Business Director, (Midwest Region), Immunology
Share this job
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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Regional Business Director (RBD), Immunology, is a critical commercial leadership role responsible for driving sales performance, strategic execution, and customer engagement across a defined geographic region. This includes the design and implementation of business plans based upon strategic business analysis. This leader will manage, coach, and develop a team of high-performing Account Managers (AMs) to ensure exceptional performance in a competitive rare disease, specialty market. The RBD will collaborate cross-functionally to optimize field strategy, enhance customer experience, and support successful launches within the immunology portfolio. This position reports to the SVP, US Commercial Engagement and Access.
Key Responsibilities:
Regional Leadership & Team Management
- Hire, lead, develop, and inspire a team of Account Managers to achieve and exceed regional sales goals.
- Establish a high-performance culture focused on accountability, integrity, strategic execution, and professional development.
- Develop and implement performance plans to support AM skill growth, capability building, and succession planning.
- Conduct regular field rides and coaching sessions to model best practices and reinforce customer-centric engagement.
- Ensure compliance with all company policies, legal requirements, and industry standards in all field activities
Strategic Planning & Execution
- Translate national brand strategy into actionable regional business plans tailored to local markets, customer needs, and competitive dynamics.
- Leverage market data, customer insights, and analytics to identify opportunities and challenges and adjust strategies accordingly.
- Oversee pull-through of brand initiatives, launch plans, and disease-area priorities across the region.
- Partner with Marketing, Market Access, Medical Affairs and other internal stakeholders to ensure aligned compliant execution.
Customer & Market Engagement
- Establish and maintain relationships with key customers, including HCPs, administrators, and influential institutions across immunology.
- Support AMs in developing deeper customer insights and effective territory plans.
- Ensure customer needs and marketplace dynamics are communicated to inform strategy, planning, and resource allocation.
Cross-Functional Collaboration
- Collaborate closely with Medical Affairs, Market Access, Patient Services, and other functions to ensure coordinated, compliant customer engagement.
- Work with leadership to support congress activities, regional events, and speaker programs.
- Ensure alignment between regional goals and national commercial priorities.
Operational Excellence
- Manage regional budget effectively, including resource allocation, travel, and strategic investments.
- Report regional performance trends, strategic recommendations, and competitive insights to senior leadership.
Qualifications:
- Bachelor’s degree required; MBA or advanced degree preferred.
- 8+ years of pharmaceutical/biotech commercial experience, with a minimum of 3–5 years leading field sales teams.
- Experience in rheumatology, immunology, rare disease, biologics, or specialty care strongly preferred.
- Demonstrated success in building, managing, and leading dynamic teams, including performance planning and skill development.
- Proven track record of strong sales performance in highly competitive specialty markets.
- Strong understanding of payer dynamics, specialty pharmacy distribution models, and access challenges in immunology/biologics.
- Excellent strategic thinking, business planning, and analytical skills.
- Exceptional communication, coaching, and interpersonal leadership abilities.
- Ability to travel extensively across the region.
- Talent Developer: Proven ability to coach, elevate, and retain high-potential talent.
- Strategic Operator: Strong business acumen with the ability to translate insights into actionable strategies.
- Cross-Functional Influencer: Effective at aligning multiple internal stakeholders toward shared objectives.
- Customer-Focused Leader: Deep commitment to understanding and addressing customer needs in immunology.
- Integrity & Compliance: Models ethical behavior and ensures compliant execution across the region.
- The preferred candidate will reside in the Chicago or Detroit area
#LI-Remote
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 $187,200 to $234,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Director, Global Quality Assurance, GCP/GLP
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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:
Reporting to the Sr. Director of Global Quality Assurance, Clinical Development and Operations, the Director of Global Quality Assurance, GCP/GLP is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical operations and development programs, including conducting, managing, and overseeing audits, managing quality issues, investigations, and inspections. Additionally, this role is accountable for GCP/ GLP oversight, and for assuring the compliance of studies with our Company’s Standard Operating Procedures (SOPs), policies, and all applicable global regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations); and will play a key role in process improvement, compliance, and inspection readiness.
Key Responsibilities:
- Conduct oversight activities to determine compliance with internal procedures, Clinical Research Organization (CRO) procedures and regulations by conducting audits/assessments/reviews of key processes clinical trials execution and sponsor oversight processes and providing actionable recommendations to mitigate or eliminate risks and issues identified.
- Support study teams and execute oversight activities, for example, attend study team meetings, collect and perform analysis of study health metrics, review study plans, advise study teams regarding matters of quality and compliance related to issues, risks, investigations, and CAPA’s.
- Conduct on-site, hybrid, and/or remote vendor or clinical site audits and or inspection readiness visits.
- Establish, manage, track, and provide status reports for Quality Objectives, and Priorities.
- Serve as the Quality Business Partner (QBP) point of contact for assigned functions.
- Manage ongoing QA for ongoing GCP and GLP day-to-day activities cross-functionally and serve as the quality subject matter expert on applicable regulatory requirements and guidance.
- Provide executive-level reporting of compliance risks, trends, and audit outcomes to senior leadership and governance committees.
- Ensure rapid communication of Quality issues, including potential misconduct, issues of significance with project/product for Health Authorities, business partners and senior management.
- Lead and support health authority inspections (sponsor and sites) and lead inspection readiness activities for assigned studies.
- Collaborate with clinical operations and other functions to develop and refine standard operating procedures (SOPs) related to GCP and GLP.
- Support activities related to key Quality Management System (QMS) programs, including Supplier Quality Management (SQM), audits, and inspection readiness and management.
- Monitors Quality Assurance, Clinical Operations metrics, reporting, and cross-functional review forums, including the Quality Management Review process.
- Stay current with industry trends, regulations, and best practices to ensure the organization remains compliant.
- Interact with third-party vendors and business partners to ensure compliance with Quality standards.
- Build rapport and trust with internal stakeholders in accordance with Zenas values, TRUE Innovation.
Qualifications:
- Bachelor’s degree and 10+ years’ experience managing Quality activities related to GCP and GLP in Clinical Development and Operations in the Biopharmaceutical industry.
- Extensive knowledge of Quality Assurance principles, practices, and standards.
- GCP and GLP compliance expertise including knowledge of applicable regulatory requirements for US FDA, China, EU, and ICH.
- Comprehensive knowledge of compliance requirements and best practices for building and maintaining the systems, processes, and tools needed for Quality oversight of GCP and GLP activities in Clinical Development and Operations.
- Regulatory agency audit hosting experience.
- Experienced in leading direct reports and managing talent.
- Demonstrated ability to act as both a functional leader and an individual contributor capable of defining and driving work independently.
- Efficacy and efficiency in making and acting on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.
- Pushes themself and others to exceed results and helps others to thrive in the face of challenge.
- When an issue arises, directs their time and energy towards resolution.
- Influences functional prioritization decisions to ensure continuous alignment with corporate objectives.
- Regularly leverages strategic relationships and networks both internally and externally.
- Understands the interdependencies between functions throughout the organization
- Embraces and demonstrates a “one team” mindset.
- Enables cooperation across teams or external partners by helping to remove and overcome barriers.
- Flexibility to work non-traditional work hours when needed, given international operations across time zones.
- Ability to travel to and work from the Zenas headquarters monthly and internationally as needed [up to 25%].
#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 $166,600 to $208.261. 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.
Ready to apply?
Apply to Zenas BioPharma
Director, Commercial Training
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Director of Training leads the vision, strategy, and execution of Zenas Bio Pharma training programs, ensuring all commercial field-facing teams are equipped with the knowledge, skills, and capabilities needed to excel. This role oversees the development, integration, and continuous enhancement of training frameworks, curricula, digital learning assets, and capability-building initiatives that support both initial onboarding and ongoing professional development across all commercial functions required for Account Management.
The Director provides strategic oversight of vendors and training partners to ensure consistency, quality, and alignment across the commercial field. Working cross-functionally with Commercial Leadership, Medical Leadership, Compliance, Marketing, HR, and Field Leadership, this role translates strategic business priorities into high-impact learning solutions that elevate field performance and drive commercial excellence.
This leader guides the development of modern learning systems and processes, identifying capability gaps through data, field insights, and performance metrics. The Director plays a key role in supporting product launch, enhancing field readiness, and strengthening leadership capabilities throughout the organization.
Key Responsibilities:
- Coordination of the new hire training and ongoing skills/knowledge training across all commercial field-facing teams.
- Ensure that the training curriculum and on-boarding processes meet the current and emerging needs of the field-facing employees.
- Oversee the development, updating, and use of all training modules that are appropriate for commercial employees.
- Create training materials that enhance the learning process; including study guides, home study materials, assessments, frequently asked questions, competitive overviews, etc.
- Lead commercial training across all settings which include 1:1 meetings, conference calls, live classroom, etc.
- Gather and analyze data from direct field observations, focus groups, and other methods to identify potential training gaps and suggest areas for improvement that will enhance performance and achieve Zenas Bio Pharma goals.
- Manage the training of commercial employees on cross functional business rules (ie. Veeva CRM, Concur, Patient Services data/CRM, etc.).
Cross Functional Collaboration
- Support leadership in leading content development workstreams across field meetings from an objective, content, and agenda standpoint.
- Work with the cross-functional teams to gather feedback on training needs and development of necessary meeting workshops to meet those needs.
- Work with sales leadership to facilitate management-level “train-the-trainer” sessions.
Systems and Employee On-going Personal Development
- Create and manage the Learning Management System (LMS), and all vendors related to field training and development resources.
- Work with corporate compliance and/or our compliance agency partner to ensure field employees are trained and up to date on policies and procedures that affect their respective functional areas.
- Other duties as assigned
Qualifications:
- Bachelor’s degree (science or business preferred) or equivalent combination of relevant education and applicable job experience may be considered. MBA preferred.
- A minimum of 10 years’ progressively responsible experience in pharmaceutical sales and training, with a minimum of 6 years in training.
- A focus on Immunology &/or Rare Disease preferred.
- Experience with product launches and Account Management experience is highly desired.
- Demonstrated leadership and teaching/facilitation ability.
- Proven ability in creating effective training materials.
- Proven application of adult learning principles.
- The ability to successfully navigate challenging situations and conversations with diplomacy, respect and flexibility when required.
- Experience in launching a product in a rare disease
- Excellent interpersonal and communication skills.
- Organization, initiative, and self-motivation.
- Project and vendor management experience.
- Professionalism, integrity, and the ability to comply with strict policy, work in a highly regulated environment and maintain confidential information and data.
- Ability to travel up to 30%.
#LI-Remote
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 $184,000 to $230,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Vice President, Head of Intellectual Property
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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, Head of Intellectual Property will lead our intellectual property (IP) function globally, including patent strategy as well as trademark protection. This individual will serve as the company’s subject matter expert on IP matters, and work closely with our research, development and technical operations colleagues to ensure patentable inventions are captured and protected. The ideal candidate will be strategic and seasoned with hand’s-on in-house biotech experience preferably in both biologics and small molecules. This position will report to the Chief Legal Officer and be based in our Waltham, MA headquarters location.
Key Responsibilities:
- Own the development and execution of a global IP strategy for a portfolio of antibodies and small molecules designed for patients with autoimmune diseases, from early research to clinical to commercial stage, and ranging from initial composition of matter to formulation/CMC to lifecycle management
- Build, manage, expand, and optimize our portfolio across patent types, including composition of matter, method of treatment, formulation, dosing, manufacturing, and biomarker claims
- Serve as the patent advisor to the organization as we transition from a clinical-stage biotech to a commercial company, ensuring IP goals are met within timeline and quality standards
- Collaborate closely with our R&D, clinical, and manufacturing teams to identify and capture inventions in a timely and comprehensive manner; advise on IP implications of development activities and decisions; support publication and data generation strategies
- Oversee outside counsel managing our global patent portfolio and supervise the prosecution of patent applications in the US and globally
- Work with our in-license and out-license partners as applicable, to ensure global protection and coordination
- Create and implement comprehensive patent lifecycle strategies across the pipeline; including developing effective secondary IP filing strategy to extend and strengthen exclusivity
- Oversee all regulatory exclusivity matters, including potential listings (e.g. FDA Orange and Purple Book) and the interplay between regulatory and patent protections
- Lead IP due diligence in connection with business development and licensing activities, including evaluation of IP assets such as exclusivity, patentability, validity, and enforceability and assessing freedom-to-operate risk
- Draft and negotiate IP-related provisions in research collaborations, license agreements, material transfer agreements (MTAs), and other commercial contracts
- Monitor the competitive patent landscape for potential risks and opportunities; advise leadership team and the Board on relevant updates and related strategies
- Protect our brands by managing trademark portfolios as well as outside trademark counsel, working with our corporate and commercial teams and other stakeholders
- Manage and protect the company's trade secrets, know-how, and proprietary information and implement procedures for trade secret protection
- Develop and maintain IP policies and procedures, including invention disclosure, record-keeping, and outside counsel management protocols
- Manage IP budget, including outside counsel spend, annuity and maintenance fees
- Educate and train internal stakeholders on IP strategy, policies, invention disclosure processes, and best practices for protecting confidential information
Qualifications:
- Bachelor's degree in a relevant scientific discipline (e.g. biology, biochemistry, molecular biology, pharmacology, chemistry, or a related field); advanced degree strongly preferred
- J.D., active USPTO registration (patent bar), and bar membership in at least one U.S. jurisdiction; current license to practice in Massachusetts preferred
- 8-13 years of patent law experience, with meaningful life sciences exposure (in-house or at a law firm) and direct experience with antibody and/or small molecule patents; experience in-house biotechnology or pharmaceutical company experience preferred
- Demonstrated experience managing a complex, global patent portfolio and overseeing prosecution through outside counsel
- Solid understanding of Hatch-Waxman and/or BPCIA regulatory frameworks and related patent litigation
- Familiarity with Orange and Purple Book listing requirements and regulatory (data) exclusivity mechanisms
- Experience conducting or overseeing IP due diligence, including FTOs or similar analyses
- Strong scientific curiosity and acumen, and the ability to engage credibly with research and clinical teams
- Ability to communicate effectively and clearly to a diverse set of audiences ranging from junior employees to senior executives to the board of directors
- Strong analytical and problem-solving skills; ability to think creatively and develop innovative IP strategies; adaptability and nimbleness in a fast-moving environment
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
#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 $283,200 to $354,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Associate Director, Medical Science Liaison (MSL), Rheumatology
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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!
Territory: MidAtlantic (NY, NJ, PA, OH)
Position Summary:
The Associate Director, Medical Science Liaisons (MSLs), Rheumatology, at Zenas are the field-based extension of our Medical Affairs department. MSLs are scientifically-trained professionals who possess strong clinical and/or scientific backgrounds whose role is to be a resource of fair-balanced and scientifically-rigorous information to the healthcare community. This position reports to the Executive National Director, US MSLs.
Key Responsibilities:
- Identify, establish, and maintain professional relationships and dialogue with international, national, regional, and local key opinion leaders and allied healthcare professionals.
- Educate healthcare professionals on Zenas’ product portfolio.
- Function as a regional medical/scientific resource and work to pair external stakeholder needs with available Zenas resources.
- Demonstrate proficiency in delivering educational resources and clinical information in response to an established need/request.
- Liaise with investigators to support clinical research activities (investigator-initiated and company sponsored).
- Facilitate speaker development and training.
- Engage in timely and fair-balanced scientific exchanges with HCPs in a compliant, ethical manner in response to unsolicited requests for information related to Zenas’ products.
- Lead, contribute to, attend, and provide scientific support at international, national, regional, and local medical conferences.
- Liaise with Clinical Operations to support company-sponsored studies.
- Actively participate in advisory boards and clinical investigator meetings.
- Gather data to generate insights and competitive intelligence to provide impactful and appropriate feedback to headquarters based on field interactions with healthcare providers, thought leaders, and congress attendance.
- Deliver internal educational training sessions for internal stakeholders, including disease state, therapeutic landscape, and product information.
- Build and cultivate working relationships cross-functionally with adherence to compliance guidelines.
- Engage in continued independent learning within the therapeutic area
- Adherence to all company regulatory and compliance policies
- Identify & coordinate execution of scientific communication opportunities at national and local congresses
- Work closely with the team to identify opportunities to generate and present meaningful data
- Provide scientific session, poster or symposium coverage when requested
- Attend face-to-face meetings to gain pertinent feedback from experts
Qualifications:
- Advanced clinical/science degree or health care professional credentials required (MD, PhD, RPh, PharmD, NP, PA, MS or equivalent)
- Minimum 3+ years MSL, field-based, or clinical position preferred
- Therapeutic area experience preferred
- Knowledge of treatment guidelines, clinical research processes, FDA regulations, and Officer of Inspector General (OIG) guidelines preferred
- Outstanding interpersonal skills, including building strong working relationships and managing and resolving conflict
- Excellent communication skills (written, verbal, listening, and presentation)
- Results-oriented
- Team oriented
- Proven track record of success
- Current knowledge & full understanding of all relevant industry, legal, and regulatory compliance guidelines
- Commitment to the highest ethical, legal, regulatory, and scientific standards
#LI-Remote
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $181,600 to $227,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Medical Director, Clinical Development, Neurology
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Medical Director, Clinical Development, Neurology, will assist in the development and execution of key activities of the Neurology Therapeutic Area in the Clinical Development department. The Clinical Development team is responsible for Phase I-III clinical research and supporting the company with medical and scientific knowledge for the therapeutic area. The Director will serve as a key resource to the VP of Clinical Development, Neurology, and as a medical expert to the company relating to products advancing through the various phases of drug development.
Key Responsibilities:
- Provide support to the VP of Clinical Development, Neurology in a variety of projects and responsibilities (detailed below).
- Assists in the generation of study protocols/amendments, design and execution of clinical study programs, and review and interpretation of study results.
- Facilitate Clinical Development goals and achievement of study quality metrics.
- Interfaces with various functions, including Regulatory, Clinical Operations, Drug Safety, Medical Affairs, and Legal.
- Assists with the tracking of (in- or outsourced) study programs, collaborating actively with Clinical Operations, Drug Safety and vendors; activities include site selection, collection and analysis of clinical data, reporting and providing ongoing medical monitoring for clinical trials (eg, assessment of eligibility criteria, managing protocol-related questions, and clinical safety data surveillance)
- Stay up to date on current information regarding regulations and guidelines for the therapeutic area and scientific advances in the relevant field
- Stays abreast of clinical and drug development information relevant to our products, including attendance to medical or scientific meetings, monitoring external competitor landscape and personal interactions with consultants and investigators
- Provides medical oversight of the implementation of clinical trials
- Maintains a working knowledge of projects in his/her functional area
- Provides therapeutic and protocol-specific scientific training to project teams and new hires
- Assists with (internal) legal inquiries on the science related to our products
- Participates in the design and review of study-related documents and professional abstracts and manuscripts
- Maintains a high level of expertise engaging key opinion leaders and investigators through impactful participation in internal meetings and attendance at professional seminars, advisory boards, workshops and educational programs
- Assists with the preparation and/or review of data listings, summary tables, study results, study reports, and clinical/regulatory/safety documents (e.g., investigator brochures). ,
- Provides strategic planning and assists with the preparation of clinical development plans.
- Assists with business development due diligence activities.
- Assists with authoring and/or reviewing relevant Pre-IND, IND, and BLA sections and generating responses to information queries.
- Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
Qualifications:
- MD, or MD with a PhD with post-graduate training and experience. Neurologist preferred but other relevant medical specialties (e.g. Psychiatry) can be considered with significant neuroscience/multiple sclerosis clinical trial experience
- Clinical or research experience in this field of specialization is highly desirable. Experience with the evaluation of injection devices and digital outcome measures is a plus but not an absolute requirement.
- Minimum of 5 years of clinical trial/research experience in an industry setting; Phase 3 clinical development and execution experience is strongly preferred.
- Hard working, driven to achieve sound results
- Experience in pharma-related clinical research and patient care or investigational site experience desirable
- Experience in analysis and interpretation of clinical data (safety and efficacy).
- Demonstrable experience in writing or editing reports of scientific research, either for regulatory submission or for scientific publications
- Ability to work in a fast paced, cross-functional, team-oriented professional environment
- Experience working with personnel with varied professional (technical and educational) backgrounds
- Experience in cultivating novel business contacts and projects via interpersonal skills
- Must have excellent verbal and written communication skills in English
- Willingness to travel 10-15% of the time, including travel to key medical conferences and study-related events such as investigator meetings.
#LI-Hybrid
The position is eligible for competitive compensation and benefits package.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $240,000 to $300,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Senior Manager, Global Quality Assurance, Technical Operations
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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:
Reporting to the Director of Global Quality Assurance for Medical Devices and Combination Products, the Senior Manager, Global Quality Assurance – Technical Operations is responsible for providing strategic and hands‑on quality oversight for late clinical‑stage—and ultimately commercial—manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). This role ensures the highest standards of GMP compliance across global operations, supports regulatory submissions and inspections, and drives continuous improvement in partnership with internal teams and external manufacturing partners. The Senior Manager will oversee batch manufacturing and testing activities, process validation, and inspection readiness to ensure robust product quality throughout the development and commercialization lifecycle.
Key Responsibilities:
- Ensure Global GMP Compliance - Maintain and enforce compliance with all applicable GMP requirements across Zenas and CMO operations, ensuring alignment with US, EU, ISO 13485, and China regulatory expectations.
- Cross‑Functional and CMO Partnership - Collaborate with internal stakeholders and external GMP partners to guide compliant execution of development, manufacturing, and supply activities, while fostering a culture of continuous improvement.
- Inspection Readiness and Regulatory Support – Support Zenas and CMO inspection readiness efforts and manage follow‑up activities related to regulatory authority inspections, ensuring timely and effective resolution of observations.
- Provide expert guidance on GMP quality assurance activities related to biologic and small molecule drug product and medical device \ combination product commercial manufacturing.
- Support the development and maintenance of internal quality systems while managing external vendors to ensure compliance and performance.
- Conduct vendor assessments, qualifications, and continuous monitoring to ensure adherence to quality and regulatory expectations.
- Support the authoring, revision, and periodic review of SOPs, policies, and controlled documents to ensure alignment with current regulatory requirements and best practices.
- Monitor local, regional, and global cGMP requirements and assess impact for the company
- Plan, execute, and document audits of CMOs and service providers involved in manufacturing, packaging/labeling, warehousing, and distribution of DS, DP, and commercial cGMP materials, including follow‑up on corrective actions.
- Collaborate closely with CMC and Technical Operations teams to provide QA support for development, scale‑up, and manufacturing activities.
- Review and approve master batch records, specifications, test methods, stability protocols, and reports
- Provide Person-In-Plant support for CMO manufacturing operations
- Review and approve executed batch records, analytical data, change controls, deviations, OOS investigations, and related GMP documentation.
- Perform batch disposition activities in accordance with applicable regulations and internal procedures.
- Participate in technical process transfers, including review and approval of commercial GMP batch records and associated documentation.
- Ensure timely communication and coordination with Operations to support uninterrupted product ensure availability
- Conduct impact assessments and approve changes in accordance with Zenas’ Change Management processes.
Qualifications:
- Bachelor’s degree with 5+ years of hands‑on experience managing Quality activities in a cGMP biopharmaceutical environment; at least 2 years of experience in medical device \ combo product functions preferred.
- Strong working knowledge of Quality Assurance principles, practices, and global regulatory standards, including US FDA GMP, EMA regulations, ICH guidelines, ISO 13485, and China GMP. Proven working experience in biopharma/pharmaceutical industry related to Quality Assurance
- Demonstrated experience in the biopharmaceutical or medical device industry with a focus on Quality Assurance for clinical and/or commercial products.
- Ability to manage workload prioritization in a fast-paced changing environment.
- Exceptional organizational skills with the ability to manage multiple tasks and deadlines effectively
- Strong interpersonal skills, written and verbal communication skills, and good team player and able to work independently
- Ability to operate as individual contributor, independently defining and driving work.
- Strong analytical and problem-solving abilities with a result-driven approach.
- Strong decision-making skills balance speed, quality, and risk delivering results under tight deadlines.
- Willingness and ability to work non‑traditional hours to support global operations across multiple time zones.
#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 $140,800 to $176,000. 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.
Ready to apply?
Apply to Zenas BioPharma
National Account Director, Payer Accounts
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 National Account Director, Payer Accounts is responsible for developing and executing payer engagement strategies that support optimal coverage, access, and reimbursement for Zenas BioPharma’s innovative portfolio. Reporting to the Executive Director, Payer Strategy, this role will lead strategic engagement with national payer organizations, Medicare and commercial health plans, pharmacy benefit managers (PBMs), and Tier 1 regional health plans to support optimal coverage and access.
The National Account Director will build and manage senior-level relationships with payer decision makers, support formulary positioning and contracting discussions, and ensure payer insights inform internal access strategy. This individual will collaborate closely with cross-functional partners including Pricing & Contracting, Medical Affairs, Sales, Market Access Operations, and Patient Services to ensure payer strategy is aligned with commercial execution and supports successful patient access.
The successful candidate will bring established relationships with key national and regional payer organizations and PBMs and demonstrated success negotiating coverage and access for specialty or rare disease therapies.
This role offers a unique opportunity to help shape payer access strategy and establish foundational payer partnerships in preparation for upcoming product launches.
Key Responsibilities:
- Develop and maintain strategic relationships with national payer organizations, Medicare and commercial health plans, pharmacy benefit managers (PBMs), and Tier 1 regional health plans.
- Execute payer engagement strategies designed to support favorable coverage, reimbursement pathways, and formulary positioning for Zenas therapies.
- Partner with the Executive Director, Payer Strategy to support payer engagement activities leading up to anticipated product launches.
- Collaborate with the Sales organization to share payer insights, support field awareness of coverage dynamics, and help address market access barriers impacting providers and patients.
- Lead and support payer contract negotiations in collaboration with Finance and the Pricing & Contracting team, ensuring alignment with overall access and reimbursement strategy
- Monitor payer coverage policies, utilization management criteria, and competitive access dynamics to inform internal strategy.
- Provide actionable payer insights and market intelligence to cross-functional stakeholders including Sales, Medical Affairs, HEOR, Commercial, and Patient Services teams.
- Provide strategic payer insights and account-level intelligence to senior leadership to help inform access strategies, coverage planning, and launch readiness.
- Support development and delivery of payer value presentations and account engagement plans.
- Maintain detailed account plans and track payer coverage developments to ensure coordinated payer strategy across accounts.
- Represent Zenas BioPharma with professionalism, credibility, and integrity while building long-term payer partnerships.
Qualifications:
- The successful candidate will bring deep experience engaging national and regional payer organizations and pharmacy benefit managers, with a demonstrated ability to influence coverage strategy and negotiate access for specialty or rare disease therapies. Experience engaging Medicare Advantage or Part D plans is preferred.
- Bachelor’s degree required; advanced degree (MBA, MPH, PharmD or similar) preferred.
- Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry, including at least 5 years in Market Access, payer account management, or managed markets roles.
- Demonstrated experience negotiating and managing contracts with national payer organizations, PBMs, and Tier 1 regional health plans.
- Demonstrated experience managing and growing relationships with national and regional payers, with an established network of payer decision-makers required.
- Proven success supporting payer strategy, formulary positioning, and reimbursement planning for specialty, rare disease, or immunology therapies preferred.
- Strong understanding of the U.S. payer landscape including commercial health plans, PBMs, specialty pharmacy distribution models, and reimbursement dynamics.
- Demonstrated ability to work cross-functionally and influence internal and external stakeholders.
- Strong communication, presentation, and strategic planning skills.
- Ability to operate effectively in a fast-paced and collaborative biotech environment.
- Willingness to travel as required to support payer engagement.
#LI-Remote
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 $196,000 to 245,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Associate Director, Biostatistics
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Associate Director, Biostatistics is responsible for leading the development and execution of statistical aspects for global clinical programs. He/she will provide project leadership and hands-on technical statistical support. This position reports to the Senior Director, Biostatistics.
Key Responsibilities:
- Independently lead the development and execution of all statistical aspects for one or more clinical development programs, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
- Review or author statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications.
- Generates or reviews study randomization, sample size/power estimations and key specifications for statistical programming implementation of analyses including programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications.
- Manage biostatistics and programming vendors.
- Develop statistical programs to ensure quality and accuracy or to perform other pre-specified or ad-hoc analyses as required.
- Work as part of a collaborative, cross-functional team with members from other disciplines.
- Represent Biostatistics, ensuring statistical input is provided throughout the clinical development process.
- Interact with regulatory agencies, and effectively address statistical questions and requests.
- Take accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.
Qualifications:
- PhD or MSc in Biostatistics or related discipline, 8+ years’ experience working across all phases of clinical trials in CRO/Biotech/ Pharmaceutical company.
- Solid knowledge of statistical methodology, clinical experimental design and analysis for clinical trials.
- Experience working with CROs and vendors.
- Good knowledge of ICH, FDA, EMA, and NMPA guidelines.
- Prior experience supporting global clinical trials.
- Project leadership experience.
- Submission experience is strongly preferred.
- Exceptional interpersonal skills and problem-solving capabilities.
- Excellent oral and written communication skills and ability to effectively communicate statistical concepts to both technical and non-technical stakeholders.
- Experience working with cross-functional teams, including clinical development, regulatory affairs, medical affairs and commercial.
- Experience working with CDISC data standards.
- Proficiency in SAS programming and other statistical software tools.
- Fluency in both English and Mandarin Chinese, both oral and written communication.
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
- Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
#LI-Hybrid
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $172,300 to 215,400. 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.
Ready to apply?
Apply to Zenas BioPharma
Senior Director, Pricing & Contracting
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Senior Director, Pricing & Contracting is responsible for developing and leading the U.S. pricing and contracting strategy to support optimal market access, reimbursement, and financial performance for Zenas BioPharma’s portfolio, including development of contracting strategies with national/regional payer organizations, PBMs, and government payer segments. Reporting to the Vice President, U.S. Market Access, this role will lead the development of pricing strategy, gross-to-net modeling, and payer contracting strategies that support both product launch planning and lifecycle management.
The Senior Director will play a key role in establishing launch pricing strategy while also overseeing ongoing pricing governance, access financial modeling, and contracting frameworks with payer organizations, pharmacy benefit managers (PBMs), and other healthcare stakeholders. This individual will work closely with the Payer Strategy team to support contract negotiations and ensure pricing and contracting decisions align with overall market access strategy and company financial objectives.
This role will collaborate cross-functionally with Finance, Market Access, Legal, Compliance, Medical Affairs, and Commercial leadership to evaluate pricing scenarios, inform access strategy decisions, and support the successful commercialization of Zenas therapies.
This role offers a unique opportunity to shape pricing and contracting strategy in preparation for upcoming product launches while supporting long-term access and financial performance for the Zenas portfolio.
Key Responsibilities:
- Lead the development and execution of U.S. pricing strategy, including launch price recommendations and lifecycle pricing management for Zenas BioPharma’s portfolio.
- Develop and manage gross-to-net (GTN) models that support financial forecasting, access strategy decisions, and pricing scenario planning.
- Design and implement payer contracting strategies, including rebate structures and contracting frameworks with pharmacy benefit managers (PBMs), national payer organizations, and regional health plans.
- Partner with the Payer Strategy team to support contract negotiations and ensure pricing and rebate strategies align with payer coverage objectives.
- Lead financial modeling and pricing scenario analyses to evaluate the impact of pricing and contracting strategies on market access, reimbursement, and overall company financial performance.
- Collaborate closely with Finance to ensure pricing assumptions, GTN forecasts, and contracting scenarios are accurately reflected in financial planning and forecasting models.
- Monitor competitive pricing dynamics, payer contracting trends, and reimbursement environments to inform pricing strategy and market access planning.
- Support the development of pricing governance processes and provide strategic recommendations to senior leadership regarding pricing decisions and contracting strategies.
- Provide strategic pricing insights to support launch planning, payer engagement strategy, and long-term market access objectives.
- Provide strategic oversight of government pricing considerations, including AMP, Best Price, Medicaid rebate implications, and 340B pricing impacts, ensuring pricing and contracting strategies align with regulatory requirements.
- Partner with Legal and Compliance to ensure pricing and contracting practices adhere to regulatory requirements and company compliance standards.
- Collaborate cross-functionally with Market Access, Commercial, Medical Affairs, HEOR, and Finance teams to ensure alignment between pricing strategy, access strategy, and commercial objectives.
- Support the evaluation of pricing and contracting strategies across different payer segments, including commercial and government payer environments
Qualifications:
- Minimum of 12+ years of experience in the pharmaceutical or biotechnology industry, including at least 7+ years in Pricing, Contracting, Market Access, or Managed Markets roles.
- Demonstrated experience developing U.S. pricing strategy, including launch pricing recommendations and lifecycle pricing management for specialty or rare disease therapies.
- Proven experience developing and managing gross-to-net (GTN) models to support financial forecasting, pricing scenario planning, and contracting strategy.
- Demonstrated experience designing and implementing payer contracting strategies, including rebate structures and negotiations with pharmacy benefit managers (PBMs), national payer organizations, government payers and regional health plans.
- Strong understanding of U.S. pharmaceutical pricing dynamics, including WAC strategy, payer rebates, contracting frameworks, and market access considerations.
- Experience evaluating government pricing implications including AMP, Best Price, Medicaid rebate exposure, and 340B pricing considerations.
- Experience supporting product launches or late-stage pipeline assets strongly preferred.
- Strong financial modeling and analytical skills with the ability to translate complex pricing and contracting scenarios into strategic recommendations.
- Demonstrated ability to collaborate cross-functionally with Market Access, Finance, Legal, Compliance, Medical Affairs, and Commercial teams.
- Experience supporting pricing governance processes and cross-functional pricing decision frameworks preferred.
- Bachelor’s degree required; advanced degree (MBA, MPH, PharmD or similar) preferred.
- Strong leadership, communication, and executive presentation skills.
- Ability to operate effectively in a fast-paced and collaborative biotech environment.
- Willingness to travel as required to support contracting discussions and internal planning
#LI-Remote
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 $219,200 to 274,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Head of Biostatistics
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Head of Biostatistics role is accountable for overall leadership of Biostatistics function, providing statistical leadership and strategic input for all clinical programs and studies as well as managing and leading the biostatistics and statistical programming team. He/she will work closely with clinical development, clinical operations, clinical pharmacology, pharmacovigilance, regulatory affairs, and project management in the development and implementation of clinical development strategy and plan to ensure that statistical elements are aligned with overall program strategy. He/she will participate in interactions with regulatory agencies, and prepare statistic section of protocols, clinical study reports, and regulatory submission materials. He/she will provide oversight to CRO partners and vendors to ensure project timelines and goals are met.
Key Responsibilities:
- Provide strategic leadership in biostatistics across all phases of clinical development.
- Oversee statistical design, analysis, and interpretation of clinical trials.
- Bring innovative statistical thinking and methods to help drive applications of statistical methods that enhance the probability of success for clinical development programs
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Data Management.
- Ensure compliance with regulatory requirements and industry best practices.
- Develop and mentor a high-performing biostatistics team.
- Manage external vendors and CROs for statistical support.
- Interact with regulatory agencies, and effectively address statistical questions and requests
- Represent biostatistics function at executive meetings, advisory board meetings, and meetings with KOLs
Qualifications:
- PhD in statistics, biostatistics, or related field with at least 10 years of experience in clinical trials is preferred; or MS in statistics, biostatistics, or related field with 15 years of experience in clinical trials
- Excellent understanding of and experience implementing statistical principles and clinical trial methodology
- Experience working on all phases of clinical trials, particularly phase 3 and POC clinical trials
- Previous experience working in small biotech is preferred
- Demonstrated experience working with and overseeing CROs, vendors and other external partners is preferred
- Understanding of ICH GCP as well as knowledge of industry practices and standards.
- Fluency in English, both oral and written
- Ability to manage people and projects
- Excellent written and oral communication and presentation skills
- Expertise in SAS and familiarity with other statistical software
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, and Project)
#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 $248,800 to $311,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Senior Director, Global Regulatory Affairs
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Senior Director, Regulatory Affairs (RA), will be the Global Regulatory Lead for a multi-indication late phase investigational product responsible for leading and overseeing global filings including US and EU, and advancing Phase 2 indications by contributing to clinical development and registrational planning. The Senior Director, RA will also have oversight of the regulatory plans for at least one early phase investigational product, leading and overseeing the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and critical regulatory intelligence. The Senior Director, RA will participate in a cross-functional team, partners with key internal/external team members/stakeholders, and partner with Regulatory CMC, Medical Writing and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. This position will report to the Executive Director, Global Regulatory Affairs and will have at least one direct report.
Key Responsibilities:
- Lead global and/or regional regulatory team on assigned projects and manage direct report(s).
- Represent Regulatory Affairs on Global Development Teams (GDTs) and relevant cross-functional sub-teams providing strategic advice and accountable for all regulatory activities.
- Develop and execute global regulatory strategy and contingencies for assigned projects.
- Prepare/coordinate/review the nonclinical and clinical content of IND/CTAs, protocol/information amendments, and BLA/MAA. Lead regulatory submission teams for assigned projects per agreed upon/required timelines.
- Monitors evolving global regulatory guidance/regulations and ensures Zenas’s regulatory submissions comply with all document/file formats and structures.
- Authors and/or collaborates on standard operating procedures for the regulatory function.
- Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions for assigned programs.
- Supports budgeting and forecasting activities for the Regulatory function.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidance. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
- In collaboration with the Regulatory team, design, implement, drive, and monitor global Regulatory strategies to inform Zenas’ programs.
- Perform other regulatory related duties as assigned.
Qualifications:
- A BS, or advanced degree, preferably in life/physical sciences
- A minimum of 10-12 years regulatory affairs experience within the pharmaceutical or biotechnology industry
- Prior late phase experience including filing of marketing applications in the US and developing both US and global regulatory strategies
- Knowledge of biologics development and regulatory processes. Understanding of small molecules and combination products development process is preferred but not required.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment.
- Independently motivated, detail oriented and good problem-solving ability. Ability to make independent, timely, and risk-based decisions (think outside of the box mentality).
- Excellent written and verbal communication skills.
- Experience interacting with key functional stakeholders (clinical development, clinical operations, QA, technical operations, supply chain)
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
- Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
#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 $218,400 to $273,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Senior Director, HCP Marketing Lead
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 is seeking a seasoned, dynamic commercial leader with extensive I&I experience and US Market understanding to lead the HCP Brand Marketing strategy and activities. Reporting to the VP Head of Marketing, the Senior Director, HCP Marketing Lead will drive the HCP marketing strategy for Obexelimab, focusing on the launch of its 1st indication in IgG4-Related Disease, setting a customer-centric vision and delivering high performance standards. This leader will oversee all aspects, from brand positioning and messaging to resource prioritization, ensuring alignment with other cross-functional partners. This is a critical role that will be instrumental in the Company’s continued success.
Key Responsibilities:
- Lead the development of Obexelimab brand strategies, focusing on product positioning, messaging, and market differentiation.
- Lead Cross-functionnal launch readiness governance and execution for Obexelimab in IgG4-RD
- Represent US Marketing on the Obexelimab US Brand Team, collaborating on strategies, messaging, and materials to ensure consistency strategic alignment across function.
- Ensure strong collaboration between the US Marketing team and counterparts on cross-functional teams, including Sales, Access & Trade, Strategic Engagement, Analytics, Medical Affairs, Compliance, Legal and Regulatory and Patient Support Services.
- Utilize market and customer insights to inform key business decisions and refine brand and customer strategies.
- Establish core messaging for a diverse customer base, including HCPs & KOL.
- Lead the creation of HCP marketing assets (disease education and promotional materials), including development, review, approval that aligns with brand positioning, messaging, and regulatory guidelines
- Lead the creation of a Market Development strategy including the development, review and approval of all materials associated with market development activities
- Collaborate closely with Strategic Engagement to collect relevant insights for the Brand Strategy, and build and execute the market development plan (Congress, Ad board, Speaker Bureau…)
- Lead customer segmentation efforts to optimize outreach and engagement across channels and ensure precise targeting.
- Leverage data and analytics to allocate marketing budget effectively across channels and audience segments, ensuring optimal utilization of marketing budgets.
- Prioritize investment opportunities and secure budget approval from senior leadership, advocating for resources to support strategic initiatives.
- Champion cross-functional teamwork and team engagement, fostering a culture of continuous learning, growth, and diversity.
Qualifications:
- Bachelor’s degree required; advanced degree in business or life sciences preferred.
- Deep marketing experience required. I&I &/or Rare Diseases experience preferred.
- Deep understanding of the US Market Dynamics
- Exceptional communication and analytical skills, with a focus on high-impact execution and results.
- Proven success in customer-centric marketing strategy development and cross-functional leadership
- Strong project management skills with the ability to manage multiple projects simultaneously while meeting tight deadlines
- Established Marketing skills.
- HCP, Account, & Digital marketing experience with multiple brands. Demonstrated expertise in omnichannel, modular marketing and content / channel strategy.
- Field experience will be a plus
- Ability to travel up to 33%.
#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 $217,600 to $272,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Associate Director, Medical Science Liaison (MSL), Neurology
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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!
Territory: US - East
Position Summary:
The Associate Director, Medical Science Liaisons (MSLs), Neurology, at Zenas are the field-based extension of our Medical Affairs department. MSLs are scientifically-trained professionals who possess strong clinical and/or scientific backgrounds whose role is to be a resource of fair-balanced and scientifically-rigorous information to the healthcare community. This position reports to the Director, MSLs, Neurology.
Key Responsibilities:
- Identify, establish, and maintain professional relationships and dialogue with international, national, regional, and local key opinion leaders and allied healthcare professionals.
- Educate healthcare professionals on Zenas’ product portfolio.
- Function as a regional medical/scientific resource and work to pair external stakeholder needs with available Zenas resources.
- Demonstrate proficiency in delivering educational resources and clinical information in response to an established need/request.
- Liaise with investigators to support clinical research activities (investigator-initiated and company sponsored).
- Facilitate speaker development and training.
- Engage in timely and fair-balanced scientific exchanges with HCPs in a compliant, ethical manner in response to unsolicited requests for information related to Zenas’ products.
- Lead, contribute to, attend, and provide scientific support at international, national, regional, and local medical conferences.
- Liaise with Clinical Operations to support company-sponsored studies.
- Actively participate in advisory boards and clinical investigator meetings.
- Gather data to generate insights and competitive intelligence to provide impactful and appropriate feedback to headquarters based on field interactions with healthcare providers, thought leaders, and congress attendance.
- Deliver internal educational training sessions for internal stakeholders, including disease state, therapeutic landscape, and product information.
- Build and cultivate working relationships cross-functionally with adherence to compliance guidelines.
- Engage in continued independent learning within the therapeutic area
- Adherence to all company regulatory and compliance policies
- Identify & coordinate execution of scientific communication opportunities at national and local congresses
- Work closely with the team to identify opportunities to generate and present meaningful data
- Provide scientific session, poster or symposium coverage when requested
- Attend face-to-face meetings to gain pertinent feedback from experts
Qualifications:
- Advanced clinical/science degree or health care professional credentials required (MD, PhD, RPh, PharmD, NP, PA, MS or equivalent)
- Minimum 3+ years MSL, field-based, or clinical position preferred
- Therapeutic area experience preferred
- Knowledge of treatment guidelines, clinical research processes, FDA regulations, and Officer of Inspector General (OIG) guidelines preferred
- Outstanding interpersonal skills, including building strong working relationships and managing and resolving conflict
- Excellent communication skills (written, verbal, listening, and presentation)
- Results-oriented
- Team oriented
- Proven track record of success
- Current knowledge & full understanding of all relevant industry, legal, and regulatory compliance guidelines
- Commitment to the highest ethical, legal, regulatory, and scientific standards
#LI-Remote
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $181,600 to $227,000. 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.
Ready to apply?
Apply to Zenas BioPharma
Director, Global Regulatory Affairs
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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 a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.
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 Director, Regulatory Affairs, will be responsible for day-to-day regulatory activities of early/late phase investigational products, leads the writing and submission of IND/CTA/amendments and future marketing application submissions, provides guidance to the team on regulatory filings and responses, and provides critical regulatory intelligence and guidance back to the team. The Director, RA participates in a cross-functional team, partners with key internal/external team members/stakeholders, and partners with Regulatory CMC, Medical Writing and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. This position will report to the Executive Director, Global Regulatory Affairs.
Key Responsibilities:
- Lead global and/or regional regulatory team on assigned projects and manage direct report(s).
- Develop and execute global regulatory strategy and contingencies for assigned projects.
- Prepare/coordinate/review the nonclinical and clinical content of IND/CTAs, protocol/information amendments, and NDA/MAA. Lead regulatory submission teams for assigned projects per agreed upon/required timelines.
- Monitors evolving global regulatory guidance/regulations and ensures Zenas’s regulatory submissions comply with all document/file formats and structures.
- Authors and/or collaborates on standard operating procedures for the regulatory function.
- Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions for assigned programs.
- Represent Regulatory Affairs on various cross-functional teams, including Development, Project Teams, Study Teams, and relevant Sub Teams.
- Supports budgeting and forecasting activities for the Regulatory function.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidance. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
- In collaboration with the Regulatory team, design, implement, drive, and monitor global Regulatory strategies to inform Zenas’ programs.
- Perform other regulatory related duties as assigned.
Qualifications:
- A BS, or advanced degree, preferably in life/physical sciences
- A minimum of 10 years regulatory affairs experience within the pharmaceutical or biotechnology industry
- Prior experience in developing both US and global regulatory strategies
- Knowledge of small molecules development and regulatory processes. Understanding of biologics and combination products development process is preferred but not required.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment.
- Independently motivated, detail oriented and good problem-solving ability. Ability to make independent, timely, and risk-based decisions (think outside of the box mentality).
- Excellent written and verbal communication skills,
- Experience interacting with key functional stakeholders (clinical development, clinical operations, QA, technical operations, supply chain)
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
- Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
#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 $192,000 to $240,000.. 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.
Ready to apply?
Apply to Zenas BioPharma