Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!
Position Summary:
The Associate Director/Director of Immunology is a newly created position within Global Research at Zenas BioPharma and will play a critical leadership role in the organization. This individual will be an Immunology lead on Zenas projects and is expected to work with cross functional stakeholders from Global Research, Clinical Pharmacology/Clinical Development and Business Development, driving research of mechanism of action, expansion of indications in various autoimmune diseases, participate in due diligence for active/upcoming candidate pipeline molecules, provide technical expertise and oversee in vitro and in vivo studies with CROs and/or academic collaborators. Expertise in innate and/or adaptive immunology, an understanding of in vivo pharmacology, and experience supporting early and/or late-stage drug candidates is highly desirable. The candidate will provide subject matter expertise (SME), scientific leadership and participation in cross-functional teams. This role will require expertise in authoring scientific documents, including regulatory documents and scientific publications. Strong interpersonal skills, proven track record working in a matrix environment to deliver on programs and goals, and an ability to work in a dynamic cross-functional team environment are required. Candidates must be able to analyze and synthesize complex scientific data quickly and condense the information into straightforward, data-driven key messages for internal and external communication. Candidates must have technical acumen and have demonstrated a strong ability to ideate, lead and execute preclinical experimental plans to support immunology and inflammation programs. This person will work closely with the Executive Director of Immunology, and other members of the Zenas research team, to meet Zenas objectives.
Key Responsibilities:
- Serve as a technical expert by working closely with R&D teams to integrate immunology/pharmacology objectives with overall program goals.
- Lead the planning and delivery of immunology/pharmacology in vitro and in vivo studies, including in various disease models to support the advancement of Zenas product candidates around the world.
- Communicate study results, data interpretation and risk assessment for consideration in the context of proposed preclinical and clinical development strategies.
- Design, direct, and interpret investigative immunology/pharmacology studies in support of research, preclinical & clinical development/regulatory strategies.
- Coordinate and oversee activities with CROs and/or academic collaborators selected to conduct the relevant immunology/pharmacology studies.
- Monitors immunology/pharmacology studies for appropriate conduct, accuracy and timely execution; reviews raw data for accuracy, reviews draft reports and finalizes them for company regulatory submissions.
- Analyzes and evaluates ongoing data outcomes and timely communicate significant results, data interpretation and risk assessments to company key stakeholders.
- Develops and manages appropriate external consultants to advance program priorities.
- Participates in the evaluation of immunology/pharmacology data as part of due diligence assessments of potential new business development opportunities.
- Works across a diverse range of projects with different drug modalities and a breadth of therapeutic areas including immunology, inflammation and autoimmune diseases.
- Assists with the preparation and review of clinical and regulatory submissions, and in the response to related information requests.
Qualifications:
- D. in Immunology; 8+ years (5+ years for AD) of experience leading immunology research for pharmaceutical drug development.
- Proven experience in writing regulatory documents (experience filing global INDs/CTAs and/or in filing BLAs is a plus).
- Ability to coordinate multiple projects and effectively manage changing priorities.
- Proven ability to manage CRO and consulting relationships across multiple programs.
- Technical training in immunology and pharmacology (a plus). Experience designing, directing and critically evaluating results of in vitro and in vivo Full understanding of analysis methods, programs and standard tools and approaches.
- Experience with vendor management and oversight, and with contract negotiations.
- Strong leadership and collaboration communication skills.
- Strong communication and interpersonal skills.
- Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
- Ability to do some travel [up to 20%].
#LI-Hybrid
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $160,000 to $208,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
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What We Do
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and delivery of immune-based therapies for patients around the world. Zenas is rapidly advancing a deep portfolio of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com
