Medical Director - Drug Safety & Pharmacovigilance

Medical Director – Drug Safety & Pharmacovigilance

Waltham, MA

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, Pharmacovigilance role is responsible for providing medical oversight of safety data from clinical trials to ensure proactive and timely benefit-risk assessments for all products in the Zenas portfolio. This is an individual contributor role reporting to the Head of Pharmacovigilance.

Key Responsibilities:

• Performs and oversees medical review of safety events to ensure accuracy, integrity and completeness of safety information, and consistency of medical coding of safety data
• Identifies and evaluates safety signals through the assessment of single case safety reports and aggregate trend analyses
• Participates in cross-functional aggregate medical review with the medical monitors.
• Provides CRO feedback regarding quality of narratives and case processing.
• Leads the internal safety committee meetings and all signaling activities.
• Assists in authoring and reviewing aggregate reports such as DSURS.
• Ensures the ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert to bring potential safety issues to the attention of the clinical team and leadership
• Contributes to safety sections of clinical documents, including preparing, review and approval of the safety portion of protocols, IBs, ICFs, CSRs, integrated summary of safety (ISS), and other documents, as needed; Drives annual DSUR preparation.
• Provides input and review of responses to regulatory agency questions regarding patient safety
• Establishes and maintains policies and procedures for the PV function

Qualifications:

• MD with a minimum of 8 years Drug Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations
• Experience working with CRO/vendors, and relationship management preferred
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment
• The ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.
• Ability to lead and influence project teams, committees, etc.
• Demonstrate excellent leadership and communication skills.