Senior Medical Director-Global Drug Safety

Description

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Senior Medical Director- Global Drug Safety

New Providence, NJ / Hybrid

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 a constantly expanding technology toolbox.

We are experts in the lifecycle of ADCs starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers.

Our CD-19-directed ADC for relapsed / refractory non-Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has been approved in the United States and in the European Union.

ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients.

We consist of nearly 300 dedicated employees, all focused on patient care and driven by purpose who carry out our mission in a flexible work environment.

If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!

To learn more about ADC Therapeutics, please visit us at https : / / adctherapeutics.com / and follow us on LinkedIn.

What You’ll Do : Position Overview

Position Overview

The Senior Medical Director will serve as the product safety physician and expert for assigned products at ADC Therapeutics (ADCT) in the Global Drug Safety function.

The Senior Medical Director is responsible for signal detection and evaluation, aggregate safety reviews, periodic aggregate safety report preparation, and the medical review oversight of vendors for Individual Case Safety Reports (ICSRs).

The successful candidate will have demonstrated prior career success as a product safety physician and managing the medical safety strategy for products in development and post-marketing, as well as effectively working within product teams.

Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders both verbally and in writing.

The individual who assumes this position will interact with multiple levels of management within ADCT external stakeholders in the medical community, as well as with global regulatory authorities.

This position can be remote based in the US. There is a preference to be based on the East Coast with the ability to travel to the New Providence, NJ office as needed for business meetings.

This role reports to the VP, Global Drug Safety.

Job responsibilities

• Responsible for all safety data review, understanding, and messaging throughout the life-cycle for assigned product(s).
• Lead safety signal surveillance, and aggregate data analysis for assigned product(s) on an ongoing basis in collaboration with the PV Scientist and / or Clinical Physician / Scientist.
• Will develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Responsible for content in the aggregate reports (such as DSUR, PADER, PBRER) and Risk Management documents (RMPs) for assigned products.
• Perform medical oversight of vendors on ICSRs, literature review, signal evaluation and aggregate report to ensure accuracy and completeness of the safety content.
• Review and contribute to safety sections within clinical documents such as Investigator’s Brochure, Study Protocol, and Informed Consent Forms.
• Lead cross-functional safety management team meetings and collaborate with team members to ensure patient safety for assigned products.
• Support and collaborate with cross-functional teams on safety-related activities, preparing and presenting safety data at meetings, providing responses to Health Authority requests, or business development queries.
• Provide support for the Safety Scientist on assigned work, such as vendor oversight.
• Collaborate effectively with key stakeholders, including business partners and vendors, and ensure they are informed of evolving safety issues and strategies.
• Support and contribute to the development of Pharmacovigilance Agreements as needed.
• Provide strategy and input into development of product risk strategy and documents as needed including RMP and REMS.

Who You Are :

• MD, required.
• 8 years+ of relevant experience in drug safety, depending on qualification, within the biotechnology or pharmaceutical industry is required.
• Oncology experience is preferred.
• In-depth knowledge of pharmacovigilance regulatory requirements, ICH guidance, and other relevant regulatory guidance.
• Knowledge of drug development process, safety monitoring and risk / benefit analysis in clinical trials.
• In-depth knowledgeable of individual case medical review, signal detection and evaluation, aggregate data review and report, as well as safety labeling.
• Experience with the writing / reviewing of safety documents such as DSURs, IB, PBRERs / PADERs, responses to Health Authority requests, submission documents and safety labels.
• Ability to work independently, and collaborate effectively with key stakeholders, including business partners and vendors.

Good team player with the ability to be flexible.

Demonstrated ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies;

to work in an entrepreneurial culture.

• Demonstrated sense of urgency and accountability for both individual and team-owned work products.
• Proficient with Microsoft Office.
• Strategic thinking, strong writing and analytic skills, excellent verbal, written communication skills.

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.

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