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Pfizer

Senior Director, Clinical Site Operations, ANZ Cluster

Posted 3 Days Ago
Be an Early Applicant
Remote or Hybrid
Hiring Remotely in Sydney, New South Wales
Senior level
Remote or Hybrid
Hiring Remotely in Sydney, New South Wales
Senior level
The Senior Director of Clinical Site Operations oversees clinical research operations across multiple regions, ensuring compliance with regulations and driving strategic initiatives to improve clinical trial processes.
The summary above was generated by AI
Use Your Power for Purpose
By connecting evidence-based support with stakeholders, you will enhance health outcomes and ensure our evidence is sound and unbiased. Your role is vital in linking evidence-based medical decision support with colleagues and stakeholders to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Whether you are developing frameworks to ensure our evidence is scientifically robust, providing unbiased and medically necessary expertise, or investigating ways to close data gaps, your contributions will be crucial.
What You Will Achieve
The Senior Director of Clinical Site Operations works above Country/Cluster/Region, Area, and Department to sponsor, chair, or lead operational /strategic lines, in addition to significant strategic initiatives, to accomplish business objectives that are multifaceted and unique in complexity.
The Senior Director of Clinical Site Operations influences top management decisions that impact business directives.
The Senior Director of Clinical Site Operations builds and leverages constructive relationships externally and cross functional internally. Influence regulatory authority or leading/contribute significantly in industry Clinical Research association and/or drive strategic initiative and innovative methodology implementation across Global Business Units.
  • The Senior Director of Clinical Site Operations (Sr DCSO) is a significant Subject Matter Expert of the principles, concepts, and theories in an assigned discipline and represents the Enterprise to influence direct business drivers associated.
  • The Sr DCSO may serve as delegate to the Regional Site Operations Head for certain key activities, initiatives, and deliverables.
  • The Sr DCSO is accountable for ensuring appropriate Site Care Partner(SCP), as well as Clinical Research Associate (CRA) resources are in place to deliver on country and site-level end to end study start up, management and monitoring activities in-line with study milestones in the designated countries/clusters/regions, as well as providing line management and overseeing the job function of the SCP and CRA. The role is also accountable to ensure overall monitoring, operational site management and oversight activities within a designated country/cluster/region and supervises the monitoring, oversight activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.
  • This is a strategic role that coordinates cross functionally with others in Study Start Up, including Start Up Project Management (SUPM), Site Activation Partners (SAP), Clinical Trial Assistants (CTA), Investigator Contracts Leads (ICL), Operational Analytics and Quantitative Sciences (OAQS), Patient Recruitment and Global Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their cluster when applicable.
  • The role also executes investigator site/recruitment strategies and site-level end to end study start up, management and monitoring activities.
  • The Sr DCSO represents Research & Development as the in country/cluster/regional point of contact for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster/regional stakeholders across the portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy.
  • This role is also responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders. Applicable to certain countries/clusters/regions, the role also represents site operations in therapeutic area/asset/study-level discussions, working in coordination with other key roles, including but not limited to, Clinician, Directors of Study Management and Clinical Study Team Leads.
  • The Sr DCSO will lead, contribute to and implement strategic initiatives as a representative of the GSSO Leadership. They will also lead initiatives that shape the clinical development environment within their country/cluster/region to facilitate Pfizer's clinical development goals and scientific leadership. For example, this role actively manages risks and identifies opportunities for clinical trial conduct through engagement with local clinical development leaders and/or regulatory authorities, activate participates in local industry forums, builds portfolio-aligned, investigational sites/network relationships. To shape performance of ethical clinical research, as needed (e.g., DCT readiness/ virtual monitoring, and drive the cycle times reduction).
  • The Sr DCSO provides insights on local/regional trends to facilitate the conduct of clinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the country/cluster and site level) on the trial's conduct.

Here Is What You Need (Minimum Requirements)
  • BA/BS with at least 14 years of clinical research experience
  • Well-developed skills in planning, observation, analysis, and problem-solving
  • Experience in creating, tracking, and reporting metrics and key performance indicators
  • People management experience and ability to effectively coach and train direct reports
  • Leading complex cross-functional teams
  • Effective verbal and written communication skills and demonstrated ability to engage with colleagues and senior stakeholders both within and outside the organization
  • Proven ability to manage multiple projects simultaneously
  • Ability to travel within the country/cluster, region and/or globally
  • Ability to be in the Sydney office on a consistent basis to interact with key internal stakeholders and team members.

Bonus Points If You Have (Preferred Requirements)
  • Master's degree (MA/MS/MBA) with over 10 years of experience, or a Doctoral Degree (PhD/PharmD/JD) with 7+ years of experience, or a DVM with 5+ years of experience
  • Exceptional interpersonal skills with the ability to persuade, negotiate, and moderate conflicts effectively
  • Ability to influence senior leadership and act as a strategic advisor
  • Proven track record in fostering a culture of inclusion and knowledge sharing
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment: Remote
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:
  • Paid parental leave
  • Access to Health & Wellness apps
  • Career Growth Experiences program
  • Recognition & rewards program
  • Paid volunteer days
  • Life Insurance Benefits
  • Pfizer Learning Academy access to top content providers
  • Access to flu vaccines & skin checks
  • Options to purchase additional leave
  • Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
Medical

Top Skills

Ai Tools
Chatgpt
Clinical Research
Metrics And Key Performance Indicators
Microsoft Copilot

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