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Associate Director, Clinical Scientist

$161.7k - $202.2k
Full-time

Zenas BioPharma

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation! Position Summary: The Associate Director, Clinical Scientist is a highly collaborative, execution-focused role that supports the development, evaluation, planning and conduct of clinical studies. This position ensures the scientific integrity and accurate interpretation of study data for clinical programs within the Neurology Therapeutic Area. Reporting to the Director, Clinical Scientist, this individual serves as a key scientific and clinical partner across global clinical programs, contributing directly to the authoring of clinical study documents, supporting trial conduct, and participating in cross-functional study teams. This position works closely with Medical Directors to support medical monitoring activities, while partnering cross-functionally with Clinical Operations, Data Management, Biostatistics, Translational Sciences, Medical Affairs, and Regulatory Affairs to translate clinical strategy into operational deliverables and ensure rigorous ongoing review of trial data for quality, safety, and protocol compliance. Key Responsibilities: Actively contribute to the scientific development and execution of global clinical studies within the Neurology Therapeutic Area in alignment with the clinical development plan. Contribute to the development and/or review of clinical and scientific content for core study documents, including clinical protocols, protocol amendments, informed consent forms (ICFs), investigator brochures (IBs), and clinical study reports (CSRs). Perform ongoing, rigorous review and interpretation of emerging clinical trial data (both subject-level and aggregate safety and efficacy data) to ensure quality, completeness, consistency, and protocol compliance. Participate actively as a member of cross-functional study teams to ensure the timely and high-quality execution of clinical trial milestones. Support the Director, Clinical Scientist in study execution activities, serving as a key clinical science resource and subject matter expert for the study team. Contribute to the preparation, authoring, and revision of regulatory submissions and health authority responses, ensuring compliance with global guidelines. Qualifications: Advanced scientific or clinical degree (e.g., PhD, PharmD, or equivalent clinical/scientific training). Minimum of 3 to 5 years of relevant clinical research experience within the biopharmaceutical or biotechnology industry, with prior experience supporting neurology clinical trials preferred but not required. Demonstrated experience in clinical trial conduct, including hands-on data review, safety monitoring, and data cleaning processes. Strong understanding of clinical development processes, regulatory requirements, and global guidelines (FDA, EMA/EU, ICH, and GCP) and applicable standard operating procedures. Excellent communication and technical writing skills, with demonstrated experience drafting, reviewing, and editing scientific or clinical content for study-related documents and clinical protocols. Proven ability to work effectively and collaboratively in a fast-paced, cross-functional, team-oriented professional environment. Strong organizational skills with the ability to manage multiple priorities and drive sound results. Willingness to travel 10–15% of the time, including travel to key medical conferences and study-related events such as investigator meetings. 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 $161,700 to $202,200. 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.

Vacancy posted 2 days ago
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