Maureen Curran Email & Phone Number

Cambridge, MA, US

Boston, Massachusetts, US

Uniondale, New York, US

• Directed corporate vision, strategic planning, and developed infrastructure; provided resourcing, financial management and oversight of PVG&RM and Medical Writing in support of medicinal products in development.
• Established first PVG&RM and Medical Writing function including implementation of software systems and other infrastructure.
• Provided procedural framework, contributed to, and oversaw the development of essential clinical development documents (Investigator’s Brochures, Protocol and Protocol Amendments, Clinical Study Reports).
• Developed risk mitigation strategies for adverse events of special interest in Phase II protocol for an investigational tyrosine kinase inhibitor.
• Established safety surveillance and monitoring sections and toxicity management of study protocols; approved standard safety language and informed consent documents for studies.
• Authored safety evaluation documents including DSURs; led a cross-functional group in planning for an integrated safety summary; active participant in NDA team.

• Created vision, strategic planning, infrastructure development, resourcing, financial management, and oversight of PVG&RM in support of first newly approved medicinal products in the US/EU.
• Contributed to and oversaw development and finalization of safety-related documents required for submission of EU Market Authorization Application (Risk Management Plan (RMP), responses to health authority queries.
• Assumed role of PVG representative for face-to-face meetings with US and EU Health Authorities during MAA/sNDA review and approval process.
• Oversaw development of post-approval safety study (PASS) required for EU approval; coordinated external/internal team in development of protocol.
• Performed and oversaw performance of consultant safety physicians in medical review and assessment of individual case safety reports (ICSRs) reported in clinical trials and post-marketing experience; transitioned.
• Developed tools to facilitate consistent and effective medical review ICSRs (list of expected terms; list of ‘always medically significant’ terms; targeted questionnaires for significant ICSRs; conventions for writing.

Cambridge, Massachusetts, US

• Led global PVG&RM department; accountable for oversight of medical evaluation of clinical trial and post-marketing safety information for Ariad products.
• Developed and maintained core knowledge of adverse events commonly associated with pharmaceuticals such as hepatotoxicity, long QT syndrome, nephrotoxicity, and bone marrow toxicity.
• Defined strategic infrastructure and implemented PVG processes in compliance with business needs and US/EU regulatory requirements for first approved product.
• Built department from four to approximately 20 team members globally with positions ranging from PVG coordinators to Senior Medical Directors and Head of EU PVG.
• Managed global PV vendors, business alliances and co-licensing partners to ensure global consistency, compliance and effective proactive management of potential safety signals.
• Established signal detection and management for development and approved products; instituted cross-functional teams dedicated to continual evaluation of safety data from multiple sources.

Cambridge, Massachusetts, US

• Established first Drug Safety department and oversaw safety-handling processes supporting 11 clinical trials in oncology, from Phase I to III.
• Transitioned drug safety infrastructure from fully outsourced model to hybrid platform with effective outsourcing of resource-intensive case processing while building and maintaining internal strategic/decision-making.
• Assumed responsibility for authoring and maintaining risk profiles (company core safety information), accurate characterization of risk profiles in key clinical documents (ICF, IB) and translating risk profiles to.
• Developed departmental infrastructure including business procedures, oversight of human resources and effective cross-functional business relationships.
• Authored SDEAs with co-development business partner and implemented complex procedures to ensure compliance with global regulations across co-development activities.
• Served as Co-chair of Risk Management Safety Team (RMST); collaborated with Co-chair (lead development MD; co-development business partner) in signal detection and management activities.

Cambridge, MA, US

• Developed and managed formal signaling process for marketed products and products in development; created and implemented template output reports to support signaling activities; created and implemented template.
• Presented results of safety signal evaluation to Global Safety Committee.
• Identified and evaluated signals; utilized internal/external data and resources; collaborated with therapeutic teams regarding ongoing analysis of benefit/risk for company products.
• Authored written responses to Heath Authority queries on safety-related issues.
• Oversaw submission of PSURs on all approved products; authored multiple sections comprising written analysis of safety signal and articulating company position on risk.
• Maintained company core safety information for marketing products and coordinated safety labeling changes in collaboration with cross-functional team members.

Cambridge, MA, US

• Managed growing team of Safety Specialists in support of compliant handling of ICSR reported during clinical trials and in post-marketing experience.
• Developed multiple event-specific data collection tools to ensure appropriate collection of relevant clinical data on special interest events.
• Authored IND Safety Reports including Analysis of Significance.
• Joined forces with representative from Regulatory Affairs in establishment of 12-week student internship in collaboration with Massachusetts College of Pharmacy; mentored approximately 10 PharmD students for six-week.
• Coordinated company transition from CoStart AE dictionary to MedDRA.
• Developed promotion pathways for Specialists to transition to supervisor and management roles.

Cambridge, MA, US

• Established resource needs, prepared job descriptions, hired and trained variety of PV positions including safety associates, PVG quality associates and operational staff.
• Established training curriculum and mentoring framework for newly hired individuals.
• Served as PV representative in review and approval of study protocols, IBs, product safety profiles and final expedited reports.
• Authored first set of standard operating procedures for approved product.
• Assumed lead PVG role in regulatory inspections; participated effectively in four FDA inspections.

Cambridge, MA, US

• Accurately processed adverse events in support of company’s first approved medicinal product.
• Performed data quality evaluation and ensured completeness and accuracy of safety data.
• Provided medical information to customers and to five Area Business Managers in Northeast.
• Delivered PV training to sales team and internal departments.

NY, US