Job Description

Overview

Upstream Bio is looking for an experienced PV Scientist to be the first PV hire for the company. In this role, you will provide operational, strategic, and analytical PV support. Reporting to the SVP of Regulatory Affairs and Quality, you will provide guidance and recommendations for the future development of the PV department including SOPs and processes, hiring, and infrastructure build.

Key Responsibilities

• Job is a mix of operational support/oversight as well as PV analytics
• Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for the assigned product(s) including SAE/AESI review and processing, SUSAR reporting, and data reviews
• Facilitate internal cross-functional Safety Management Committee meetings for routine signaling and ad hoc urgent safety issues; includes coordinating materials, data presentation and all outputs, and agenda
• Review and provide PV input for development and updates of protocols, IBs, ICFs, CSRs and other relevant study documents
• Project lead and author for annual DSUR
• Oversight of vendor, specific to PV deliverables and metrics
• Provide strategic direction for the PV department on initiatives such as functional service provider model and global safety database strategy
• Coordinates with Quality on CAPAs, quality events, and process improvements
• Responsible for the development of supportive internal processes and SOPs
• Provide PV subject matter expertise to cross-functional platforms throughout the company

Qualifications

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• Minimum 10/12 years pharmaceutical industry experience, including a minimum of 8 years experience in PV
• Knowledge of MedDRA terminology and its application
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
• Experience in the preparation and authoring of pre- and post- aggregate safety reports
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Ability to execute and follow-through to completion and documentation
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Independently motivated, detail oriented and good problem-solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence across multiple functions
• Gene therapy experience is not required
• Experience working on BLA/MAA filings is preferred

About Upstream Bio

Upstream Bio is a public company based in Waltham, MA.

We are a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. We are developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. Upstream Bio has advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma and chronic obstructive pulmonary disease (COPD). Our team is committed to maximizing verekitugs unique attributes to address the substantial unmet needs for patients underserved by todays standard of care. To learn more, please visit

Seniority level

• Director

Employment type

• Full-time

Job function

• Research and Manufacturing

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