Medical Director - Patient Safety
At AstraZeneca, we turn ideas into life changing medicines. Working here means to follow the science, put patients first, play to win, do the right thing, and be entrepreneurial. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine, positively impact patient experience and bring big new ideas to life. As an Medical Director (or Associate Medical Director), US Patient Safety in Wilmington, DE, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
Main Duties and Responsibilities:
We are currently seeking a physician to join our team as an Associate Medical Director or a Medical Director, US Patient Safety. The role holder will provide medical leadership as a safety expert for assigned products in an oncology therapeutic area and ensure effective collaboration with other physicians and teams. optimize overall benefit/risk and safety of patients who receive AstraZeneca products. The role holder is accountable for US post-marketing product safety evaluations, patient safety support and surveillance activities on AZ US sponsored clinical studies and real-world evidence studies, safety review of externally sponsored research proposals, and development of US specific documents such as periodic safety reports or regulatory responses as appropriate, contribute to Global benefit risk assessment, risk management strategies and related activities. The role holder will lead USPS in product launch planning and contribute to US submissions and product labeling activities. Should a REMS be required, the role holder will contribute to the development, management and safety reporting of the REMS program. The role holder will also be accountable for strategic safety support to US medical teams, including development of patient centric brand safety strategy, strategic safety support to the US Medical and brand teams, US product benefit/risk assessment, management, mitigation, training, and communications. The role holder also collaborates with US and Global Patient Safety, Medical Affairs, Regulatory Affairs, R&D, and Legal functions as appropriate.
The role holder may also be required to represents AstraZeneca and US Patient Safety at external events, networks with colleagues and experts, providing consultancy in own area of expertise and serving as a resource for others by sharing experience within and beyond project team and function. The role holder should ensure that all work is carried out with regards to AstraZeneca standards and external regulations, closely collaborate with other relevant stakeholders in the global and US business (including regulatory, medical affairs, Real World Evidence, legal), ensure efficient and effective leadership and management of project information, strategy, quality standards, and integrity of information interpretation.
Education, Qualifications, Skills and Experience
- MD or equivalent degree from US or reputable foreign medical university
- Team player with strong collaboration and communication skills
An Associate Medical Director candidate should also meet at least one of the following requirements:
- 1-2 years of clinical experience post-registration/certification
- 1-2 years of pharmacovigilance experience as a safety physician in a pharmaceutical environment
- 2 or more years of clinical development experience in a pharmaceutical or academic environment
A Medical Director candidate should also meet one or two of the following requirements:
- 2 or more years in clinical practice
- 3 or more years of pharmacovigilance experience (the majority of which as a safety physician) with clear evidence of delivery in a pharmaceutical company
- At least 3 years of clinical development and post-marketing research experience as a study physician in the pharmaceutical industry or as an Investigator in academia
- Extensive medical knowledge
- High level of competence, with an ability to balance this with industry standards to achieve business goals
- Postgraduate training with board certification or equivalent in a subspecialty
- Extensive safety experience in a pharmaceutical industry
- Working knowledge of epidemiology
- Working knowledge of US and Global regulations and guideline
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.