Medical Director - Drug Safety & Pharmacovigilance, Waltham

Medical Director - Drug Safety & Pharmacovigilance

4 Days Old

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

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.

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $227,200 to $284,000. 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.

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Location:: Waltham

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