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ADC Therapeutics America Inc
New Providence, NJ | Full Time
7 Months Ago
Director, Project Management (New Jersey, US or Remote)
Full Time 7 Months Ago
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ADC Therapeutics America Inc is Hiring a Remote Director, Project Management (New Jersey, US or Remote)

Description

Why ADC Therapeutics:

ADC Therapeutics (NYSE: ADCT) is a rapidly growing commercial-stage biotechnology company that is improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs) for patients. ADC Therapeutics’ CD19-directed ADC ZYNLONTA™ (loncastuximab tesirine-lpyl) was approved by the FDA on April 23, 2021 for the treatment of adult patients with relapsed and refractory diffuse large B-cell lymphoma.

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.  

Job Description: 

The Director, Project Management (AD, PM) will be responsible for leading the day-to-day interactions with the Safety Service Providers (SSPs). The position will provide expertise, leadership, and collaboration with internal cross-functional team and the external SSPs; ensure overall excellence of SSP performance through the delivery of high-quality project management. The Director PM may assume other responsibilities as assigned by Management. 

The Director, PM will report to the Senior Director, Global Pharmacovigilance Operations (PVO) and will be based in the New Jersey office. However, there is an option for this position to be remotely based, with travel to the NJ office based on business needs.

What You’ll Do:

· Serves as a key interface person for the SSP, liaise with SSP project manager(s) and respective functional leads for effective project management, to ensure optimal performance of SSP across the service scope, including but not limited to, safety database hosting, individual case safety reports, aggregate reports, regulatory reporting, literature reviews, risk management, signal management, audit and inspections, etc.

· Leads the regular project team meetings with SSP project manager(s), including agenda topics compilation, meeting minutes review and finalization, and follow up action tracking.

· Coordinates key project plan document review with SSP and ADCT team and ensures quality and timeliness of the review.

· Manages the service scope, budget planning, and expense reimbursement with the SSPs in collaboration with responsible safety functions.

· Collaborates with members in ADCT Global Drug Safety and other cross-functional teams for a unified approach in working and communicating with the SSPs.

  • Supports ADCT Global Drug Safety departmental policies and SOPs that address SSP oversight.
  • Coordinates/Oversees SSP support to ADCT Global Drug Safety during audits and inspections
  • Oversees/implements best practices for vendor management as related to the SSP.
  • Supports BLA and MAA regulatory submissions as related to the SSP. 
  • Supports ADCT Global Drug Safety and interdepartmental and/or corporate initiatives as related to the SSP.

Requirements

Who You Are:

5 years of experience in the biotechnology or pharmaceutical industry with a focus on project management; 2 years of experience managing safety service outsourcing vendors and relationships, or equivalent experience with safety service providers. 

  • Able to set up project plans, identify project risks with appropriate mitigations and contingency planning, implement solutions; track SSP deliverables and maintenance of timelines
  • 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.
  • Hands-on experience with proprietary safety databases, individual case safety reports, aggregate reports, regulatory reporting, literature reviews, etc. Knowledge of MedDRA dictionary. 
  • Experience implementing best practices for vendor management. 
  • Strong relationship building skills with ability to interact effectively in a multifunctional, multicultural, growing organization.
  • Strategic thinking, strong organizational and analytic skills, collaborative spirit, strong project management; excellent verbal, written communication skills, and attention to detail.

Job Summary

JOB TYPE

Full Time

POST DATE

08/18/2022

EXPIRATION DATE

11/29/2022

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