Director, Pharmacovigilance

Responsible for building a pharmacovigilance infrastructure together with the CMO, and in collaboration with clinical, biostatics, regulatory, and other relevant functions. Function as a clinical safety expert responsible for developing overall pharmacovigilance strategies/policies for individual products as well as for Shattuck Labs as a whole. Works closely with pharmacovigilance vendor and manages all activities related to pharmacovigilance for clinical trials in compliance with regulatory requirements. Independently handles aspects of safety signal identification, evaluation, and risk mitigation. Proactively creates communication plans for important safety topics and identified risks. May serve as an author for certain safety documents and contribute to protocols, investigational brochures (IBs), informed consent forms (ICFs), and other regulatory filings.

Summary of Key Responsibilities

* Risk Management (signal identification, evaluation, mitigation): Provides oversight of all aspects of drug safety surveillance for Shattuck Labs' investigational products. Performs clinical assessment of all serious adverse events, including those requiring submission to regulatory authorities (e.g., IND Safety Reports). Provides pharmacovigilance review of INDs, BLAs, annual report summary statements, and Periodic or Developmental Safety Update Reports (DSURs). Works in conjunction with clinical safety physician/study physician in assessing potential safety issues/signals. May independently integrate and analyze safety data from multiple sources to deliver comprehensive conclusions. Responsible for safety signal detection and evaluation, monitoring, and benefit/risk assessment. Is a key participant in developing, and implementing, the risk management strategy for assigned products. Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. Demonstrates familiarity with pharmacovigilance and epidemiology related literature.
* Safety Communication: Develops strategy for communicating safety information internally and externally with clinical study physician. May first author safety communications.
* Documentation: Documents meeting discussions, decisions, and action items for Safety Review Committee (SRC) activities. Ensures the appropriate archiving of the team meeting documentation. Maintains a current signal tracking log.
* Author: Provide safety strategies for development of protocols and safety input for the development of informed consent forms, investigator brochures, statistical analysis plans, clinical study reports and other relevant documents. Responsible for authoring the IB summary data and guidance for the investigator, including the reference safety information (RSI). Work with PV vendor on aggregate safety reports (e.g., DSURs, PSURs), according to the agreed process and timelines. Author adverse event narratives where applicable. Author/provide strategic input on safety responses to regulatory documents in partnership with other functional experts. Develop/author Safety Monitoring Plans, Safety Data Exchange Agreements, and Charters.
* Project Management: Coordinates and leads cross-functional Safety Review Committee meetings. Takes the lead role in discussion of the results with the SRC Chair and other key stakeholders. Provide necessary information for SMC in collaboration with biostatistics. Provide oversight for the review of safety events to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data. Oversees management of pharmacovigilance systems (safety procedures, pharmacovigilance training, safety databases, pharmacovigilance master file).
* Oversees CRO for Pharmacovigilance: Provides oversight of vendor case management and continued process improvement and oversees safety reporting activities of CRO to ensure quality reports. Manages PVG CRO budget and vendor performance.
* Procedures: Contribute to implementation of safety related Corrective Action and Preventive Action (CAPA) for assigned products. Establish and maintain policies and procedures and training for Pharmacovigilance. Oversee and guide remediation of pharmacovigilance deficiencies cited during regulatory or internal audits. Keep abreast of new safety regulations and guidance from the regulatory authorities.

Required Qualifications

* Possess strong medical and drug development knowledge.
* A life sciences/pharmacy/nursing degree/MD/MSc/PharmD/PhD in scientific discipline
* 12+ years of clinical drug development experience, including 8+ years of patient safety pharmacovigilance experience. Early phase oncology- and/or immunology- related experience preferred but not required.
* Advanced knowledge of Pharmacovigilance regulations and documentation requirements: in depth knowledge of GCP, clinical safety documentation and reporting of adverse events, regulatory requirements, pharmacovigilance methodology
* Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
* Experience in the preparation and authoring of individual and aggregate safety reports
* Working knowledge of principles of data collection, analysis, retrieval, and summarizing
* Understanding of medical or drug terminology; knowledge of MedDRA terminology and its application
* Experience with safety databases and vendor management
* Experience in writing regulatory documents and submissions
* Excellent verbal and written communication skills
* Attention to detail, strong problem-solving skills and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
* Thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
* Excellent leadership, organizational, and collaboration skills in a cross-functional, multi-faceted environment
* Ability to maintain primary focus on the safety of the patient
* Excitement about the vision and mission of Shattuck Labs

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