Senior Medical Director, Clinical Development Rheumatology

Zenas BioPharma•Waltham, MA

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 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 Senior Medical Director, Clinical Development Rheumatology is a highly visible role within the organization. In this strategic role, the individual will lead the clinical development plan for one or more assets within Zenas’ extensive portfolio and oversee the medical and safety responsibilities for global clinical trials across all phases of development. This individual will collaborate closely with Clinical Operations, Clinical Pharmacology, Medical and Scientific Affairs and other functions, and externally with Key Opinion Leaders and Investigators, Regulatory Authorities, Patient Advocacy Groups (PAG) and others involved in the scientific and clinical development process.

Requirements

MD or MD/PhD in Rheumatology with a minimum of 8 years of clinical development or equivalent experience, especially in late-stage clinical studies, preferred.
Clinical experience in Immunology, Rheumatology, or other autoimmune disorders a plus.
Demonstrated leadership, organization, and excellent written and verbal communication skills.
Ability to work collaboratively in a fast-paced, team-based matrix environment.
Experience leading global teams: experience working with China is highly valued.
Comfortable working in a demanding, fast-paced, start-up culture with evolving processes.

Responsibilities

Lead the clinical development plan and overall clinical strategy for multiple global programs.
Help to identify unmet medical needs in autoimmune disorders.
Overall responsibility for clinical study design, including: authoring study synopses and protocols, collaborating with biostats to develop the statistical analysis plan (SAP), providing medical monitoring and safety oversight to ensure the safety of subjects and adherence to the protocol and good clinical procedures (GCP).
Interpreting clinical data and authoring clinical study reports (CSR).
Develop strong relationships with Investigators, research sites and KOLs to design clinical trials that answer important medical questions.
Support publication strategy of clinical data through preparation and submission of clinical findings to scientific journals and conferences.
Lead clinical strategy for regulatory submissions, responses to regulatory questions and presentations at regulatory meetings.