Nurse Claims Analyst
ZipLiens
Senior Medical Director, Global Pharmacovigilance
ADC Therapeutics
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- The Senior Medical Director will serve as the safety strategy leader involved in safety related and benefit-risk decision making activities for assigned product(s) at ADC Therapeutics (ADCT).
- 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 engaged and influenced multiple cross functional teams including but not limited to Clinical Development, Regulatory, Biometrics, Medical Affairs, PV/Business partners, Affiliates and External Service providers as appropriate.
- The Senior Medical Director plays a lead role in owning, shaping and planning the safety strategy and activities for their assigned product(s). This would include acting as the lead point of contact for safety with cross functional leaders, defining long term safety related objectives, ability to articulate the overall design and the requirement of their defined safety strategy in the context of the overall clinical development program (e.g., TPP, CDP) and or post-marketing requirements.
- This role is accountable for the safety profile, product specific patient risk management strategies and activities and ensure safety communications approaches are implemented and can be demonstrated to be effective.
- The Senior Medical Director role is pivotal to the overall success of the product(s) they are assigned to. They are empowered to work independently under the oversight of VP, Global PV.
- 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.
- There is a preference for this role to be based near our office and have the ability to travel to the New Providence, NJ office as needed for business meetings. However, there is no in-office requirements and the role can be done remotely.
Requirements
- MD, required.
- 15 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.
