Medical Director, Clinical Development, Neurology

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.
• 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.
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Additional Information

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 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.

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