Medical Director, Clinical Development, Neurology

Zenas BioPharma•Waltham, MA

5d•$240,000 - $300,000•Hybrid

About The Position

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.

Requirements

MD, or MD with a PhD with post-graduate training and experience in Neurology (Board Certified or Board Eligible) with focus on Multiple Sclerosis. 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.

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