Medical Director, Senior Safety Physician

AstraZeneca • Gaithersburg, MD

125d

About The Position

As a Medical Director, Senior 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.

Requirements

• BS degree in medicine and experience as a physician or academic clinician.
• 7+ years of proven experience.
• Extensive experience in Pharmacovigilance, 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.

Nice To Haves

• 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.

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.
• Participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy.
• Represent Patient Safety in cross-functional discussions with internal and external partners.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree