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Medical Director, Patient Safety Physician

Location Gaithersburg, Maryland, United States Waltham, Massachusetts, United States Job ID R-120218 Date posted 11/11/2021

Do you have expertise in, and passion for Patient Safety? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Working with one of the broadest and deepest Biopharmaceutical pipelines in the industry offers the possibility to work on the most novel molecules at all development stages. It takes each of us challenging our thinking to keep pushing our pipeline forward and shape the future of drug development at AstraZeneca.

As a Medical Director, Patient Safety Physician, you are a senior leader within Patient Safety and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca products. You also have a role in shaping the culture of the department; and will act as a coach and mentor to more junior Patient Safety staff. You will also ensure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. We encourage you to closely follow medical developments within assigned areas to incorporate emerging data and trends into the safety strategy

Main Responsibilities:

  • Providing strategic Patient Safety input to drug development and post-marketing programs

  • Collaboration with team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings.

  • Ensuring expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation).

  • Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee.

  • Lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities.

  • Lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs.

  • More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external partners.

Minimum Requirements:

  • BS degree in medicine and experience as a physician or academic clinician

  • 5+ years of proven experience

  • Extensive experience in Pharmacovigilance and drug development , with clear evidence of delivering to a high standard

  • Detailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency

  • Experience in designing, supervising and implementing clinical trials and interpreting trial results

  • Strategic leadership of complex drug projects

  • Understanding of the medico-legal aspects of pharmacovigilance

  • Proven leader of cross-functional delivery teams.

  • Demonstrated ability to influence key business partners within and outside of company

  • Proficiency with both written and verbal communications

  • A thorough knowledge of the pharmaceutical/ biopharmaceutical industry, especially clinical research and global regulatory requirements (BLA, NDA or MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities

Preferred

  • PhD in scientific field

  • 5+ years of proven experience

  • Therapeutic area expertise and commercial understanding

  • Extensive general medical knowledge

  • Able to work across TAs and Functions

  • Research background, including peer reviewed publications

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them



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.

50056669 F CDPN R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.