Associate Director, Global Patient Safety Operations

Ironwood Pharmaceuticals•Boston, MA

4d•Hybrid

About The Position

Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options. The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years. Position Summary: As a key member of Global Patient Safety Operations, the Associate Director, GPS Ops, is responsible for operational management and oversight of case processing activities, vendor management and supporting functions such as alliance management, quality & compliance, and safety systems. The incumbent will join the Global Patient Safety Operations department reporting directly to the Vice President, Global Patient Safety.

Requirements

Bachelor's degree in life sciences; A health professional degree (e.g., PharmD, BSN, RN, MPH) is preferred.
7-10 years of relevant experience that includes experience in case processing for US and EU clinical trials.
Strong working knowledge of global safety regulations for regulatory authorities such as of FDA, MHRA, EMA (GVP), ICH Guidelines and their specific implications to case processing, patient privacy, and safety databases.
Experience with clinical trial data and safety reporting tools such as Argus Safety, Electronic Data Capture, electronic reporting gateways, elluminate platform
Knowledge of MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases

Responsibilities

Provide oversight of operational and case management activities for safety reporting for both investigational and marketed products
Managing Case Processing Vendor including oversight of daily responsibilities, providing guidance, training, and evaluating vendor performance and quality of work
Generate performance and compliance metrics for the PV vendor and monitor for trends and possible improvements
Identify and lead needed upgrades to Safety Database functionality in conjunction with Vendor, IT and project management colleagues
Lead and provide safety operations support to Clinical Trial Teams (CTT) on assigned studies including input to protocols, IBs, CSRs and other relevant study documents
Develop documents related to safety case processing and reporting such as Safety Management Plan, Safety Reporting Forms and completion guidelines, reconciliation plan, data handling conventions, blinding and unblinding protections and SOPs
Review new or updated PV regulations to identify required modifications to internal Ironwood procedures and/or agreements with vendors or business partners
Maintain inspection readiness and collaborate with internal teams and vendors to prepare for Regulatory Authority inspections and internal/external audits as subject matter expert for PV operations
Contribute to responses to safety requests from Regulatory Authorities and internal teams