Senior Director, Global PV Operations & Safety Science chez ADC Therapeutics

Description

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

Why ADC Therapeutics

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization.  Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission.  ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics and in earlier lines of therapy to determine if it has potential to treat an even broader range of patients. In addition to ZYNLONTA, ADC Therapeutics has a PSMA-targeting ADC in ongoing development. 

We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients.  If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey!  To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at  https://adctherapeutics.com/ and LinkedIn. 

Position Overview

The Sr. Director Global Pharmacovigilance (PV) Operations & Safety Science is accountable for developing and implementing the strategy for PV operations and driving excellence in operational execution. The role is accountable for and oversee the execution of key safety processes that are essential to meet regulatory requirements and compliance, and aid in robust scientific analysis.  This role provides strategic direction for the overall PV operations, and ensures efficient, cost-effective, high quality and compliant delivery of operational activities by establishing strong relationships with cross-functional teams, vendors supporting safety operations deliverables and PV Partners (PVPs). This role is accountable for operational aspects and support/lead signal and risk management activities for the product(s). 

The position reports to the VP of Global Patient Safety and Pharmacovigilance and is remote based but will be affiliated with the New Providence, New Jersey office location and will be expected to travel to the office as needed for meetings and other business needs.

Job responsibilities

• Accountable for delivery of PV operation activities and ensuring timely and consistent execution globally

o Manage and oversee PV vendor responsible for ICSR management (collection, processing, and regulatory reporting in accordance with global ICSR regulations) including associated quality and training activities to ensure standards and timelines are met for the company's product portfolio

o Collaborate closely with stakeholders including PV partners (PVPs) to ensure operational deliverables are met and to continually identify opportunities for efficiency and excellence

o Ensure regulatory compliance with global regulatory authorities and submission compliance with PVPs 

o Provide vigilance expertise on operational processes to stakeholders including clinical development, clinical science, biometrics, data management and commercial teams 

o Implement and maintain the PV QMS and ensure adherence to SOPs and best industry practices

o Work in collaboration with Quality Management personnel on PV QMS to develop or update PV SOPs/WI. Ensure up-to-date processes and procedures for operational activities in the end-to-end safety process including but not limited to ICSR management, regulatory reporting, safety agreements, signal and risk management 

o Ensure awareness and training of appropriate Company personnel and external groups of PV principles, policies and SOP

o Leads, develops, negotiates, implements and maintains safety agreements (PVAs, SDEAs, SMPs) with PVPs and IITs

• Drive and set safety performance standards within PV operations to ensure quality and compliance

o Ensure tasks are performed according to global regulatory requirements and internal standards

o Monitor vendor to achieve defined KPI, compliance metrics, invoice management, budget and quality standards for PV operations deliverables

o Develops and implements operational sourcing strategies to optimize cost, capacity, quality and performance by finding the right balance between internal and external resources

o Ensure PV operations and PS&PV function are ready and assist quality personnel during audits & inspections, preparation of comprehensive audit strategy, root cause analysis and CAPA development to ensure timely completion

• Accountable for operational aspects and support/lead aggregate reports, signal and risk management activities.

o Collaborate with and support the safety physician on signal detection process including data collection, analysis and reporting as well as coordinate signal detection meetings and document appropriately

o Supports the safety physician in signal detection documentation activities including but not limited to signal validation, implement and maintain signal and HA safety commitment trackers

o Contribute to the strategy and review of safety assessments (safety topic review) and drug safety reports for signals or issues including product quality or in response to RA requests

o Collaborates closely with PVPs to ensure operational requirements for safety risk management are met

o Operationally support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, SASUSAR)

o Collaborate with the vendor, PVP and Regulatory members to develop submission schedule for all aggregate safety reports, REMS documents and other regulatory documents for Regulatory Submission to ensure effective project management.

o Provide scientific and safety support for the preparation, quality control and compliance of Benefit-Risk and aggregate safety reports including PBRER, DSUR, RMPs, REMS, risk communications, assessment reports, and regulatory responses, and aid with project plans for timely execution

o Support in the preparation, review, approval, and version control of CCSI or potential safety variations in coordination with key stakeholders, recording all supporting documentation in the CCSI preparation

• Contribute to clinical study management from a safety perspective

o Supports the preparation and review of the safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, relevant sections of clinical study reports, IND/NDA/BLA/MAA, renewals and other regulatory submissions

o Support in the preparation of RSI and maintains the RSI effective date for implementation.

o Participates in investigator meetings as required to train the site personnel in SAE data collection and reporting

o Support the safety physician in review of clinical safety data for iDMC meetings

o Ensure safety data reconciliation (SAEs & AESIs) activities between safety and clinical databases are performed by vendor

Requirements

• Bachelor’s Degree including a Health care degree (RN, Pharm D) or PhD in biomedical or pharmaceutical sciences 

• Extensive drug safety experience in oncology highly desirable

• Minimum 10 years of PV operations experience within the biotechnology or pharmaceutical industry is required

• Prefer management experience with direct reports.   

• High EQ with demonstrated skills and experience fostering a positive culture within a PV organization

• Expert knowledge of global PV requirements, e.g. US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines

• Experience and extensive working knowledge of MedDRA and proprietary safety databases

• Experience managing business process outsourcing vendors and relationships

• Experience with Quality Management Systems (QMS) and the development of SOPs. 

• Experience and extensive working knowledge of PV processes for individual case medical review, signal detection and evaluation, risk management, aggregate data assembly, review and report, as well as clinical study safety management 

• Experience with compilation, writing and reviewing safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels

• Experience with audit and inspection

• Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization

• Proficient with Microsoft Office 

• Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail

Join Our Inclusive Team

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.