Global Safety Program Lead

Job Title: Global Program Safety Lead

Location: Gaithersburg

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Introduction to Role:

The individual is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); the role holder will work with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level. Acts strategically to generate opportunity and value for the asset or indication to optimize benefit risk and maintain a competitive advantage. Line manages a team of safety physicians and / or scientists. They will be required at times to deputise for the Global Safety Head.

The individual will operate according to the highest ethical, quality and compliance standards in compliance as provided by global and local regulations, GxP practice and AZ procedures.

Accountabilities:

Safety Expert

• Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.

• Accountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).

• Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy.

• For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset

• Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.

• Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).

• Leads response to complex technical issues for specific safety aspects for the assigned asset(s).

• Is accountable for safety contribution to study designs and study concept delivery within their assigned program

• Through integrated understanding of the product strategy, provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s).

• Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset.

• Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.

• Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team.

• May be required to support in-licensing opportunities.
• Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours

• Accountable for implementation of new processes, systems and learning, including new ways of working.

• Prioritizes risk mitigation strategies and effective trouble shooting.

• Line manages a team of safety physicians and / or scientists.

Scientific clinical safety analytical accountabilities

• Maintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information,

• Accountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally

• Delivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals.

• Serves as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data.

Messaging and External Impact

• Maintains a high degree of understanding and awareness of new and emerging clinical safety developments, globally.

• Maintains strong networks globally and works with international colleagues and with external alliance partners on safety initiatives and regulatory issues.

• If required, able to provide safety guidance for investigator-initiated trials in cooperation with regional marketing companies.

• This Job description is not exhaustive and may include other job-related duties as assigned.

Essential Skills/Experience:

• Medical degree or equivalent degree in biomedicine or science

• 5 years extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities

• Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs.

• Ability to collaborate across a matrixed environment and influence cross-functional- leaders on decision-making (e.g. Clinical Development, Medical Affairs, Regulatory Affairs).

• Thorough knowledge and understanding of pharmacovigilance & safety deliverables, standards and processes at a global level; including pre and post launch experience.

• Experience of global regulatory submissions and interacting with major regulatory agencies.

• Demonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists.

• Available to travel domestically and internationally

• Demonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement.

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

• Our US Footprint: Powering Scientific Innovation - YouTube

The annual base pay (or hourly rate of compensation) for this position ranges from $221,630 to $332,435. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected]

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.