Pfizer · 4 hours ago
POD Head of APAC Site & Country Operations (Executive Director)
APAC - Remote
Full-time
Onsite
Director/Executive
10+ years exp
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Responsibilities
Partner with the VP Head of ROW Site & Country Operations to establish a strategic vision and short to long-term plan for Oncology GSSO within their regions.
Oversee the clinical trial deliverables across all studies within their regions, ensuring high quality delivery and effective resource utilization. This will require effective co-working and coordination with the PRD Area Heads across regions.
This team includes Site Care Partners (SCPs, Site Monitors, country Study Operations Managers (cSOMs), Directors of Clinical Study Operations (DCSOs) and Directors of Study Management (DSMs).
Actively develops and leads senior-level resources to deliver on critical business priorities.
The POD Head of Site & Country Operations will be a critical member of the GSSO Leadership Team ensuring the successful establishment of the POD country organization.
Partnering with other POD Heads of Site & Country Operations and PRD country leadership they will be accountable to ensure globally trial delivery.
They will oversee the clinical trial deliverables across all Oncology studies within their regions, ensuring high quality delivery and effective resource utilization of POD & PRD country-based GSSO resources.
They will manage the day-to-day operations of the Oncology GSSO in regions, as well as have a strategic role in creating and implementing robust clinical trial programs in the assigned regions.
They will define and build sustainable, change-agile in-Country strategies supported by resources with capabilities able to pivot with POD priorities and emerging business needs and opportunities.
Develops and fosters communities of practice and a culture of inclusion to share knowledge and supports colleague development while leveraging organizational capabilities.
Responsible for strategic and operational direction to staff overseeing the internal and/or strategic partners performance against an agreed set of Key Performance Indicators for quality, speed and cost in support of Pfizer’s goal.
Prioritizes emerging business issues and challenges affecting study preparation; start up and delivery and oversight and ensures strategies/solutions are developed and implemented to fully mitigate them.
Oversees in country operations activities of our internal and/or strategic partners in the conduct of study initiation, monitoring, and end of study procedures.
Determine the best utilization of Oncology GSSO resources within region, and the optimal organization of the Oncology GSSO infrastructure and staff. Able to leverage experience working in varying resource models (i.e. Hiring, Functional Service Provider, CRO Full Package Outsourcing, Hybrid, etc.) in POD to scale the Oncology GSSO organization as needed to meet the demands of the clinical portfolio.
Make decisions on selecting and managing local Oncology GSSO staff, colleagues and contractors.
Accountable of investigative site engagement and partnership.
Accountable for ensuring effectiveness of regional trial management and monitoring for high quality delivery.
Responsible for developing and maintaining SOPs and training guides applicable to a global organization.
Ensure consistency and best practices are followed on all processes, protocols, and within the Clinical Trial Management System (CTMS).
Take a lead role in managing projects within respective regions and collaborating globally and across departments such as clinical development, drug supply, regulatory, data management, biostatistics, medical writing and drug safety; and building and maintaining relationships with key stakeholders, including investigators, regulatory authorities, and ethics committees.
Provide local Oncology GSSO staff with appropriate coaching, mentoring and development
Ensure proper training is implemented to demonstrate GCP/ICH compliance.
Responsible for quality control plan for the clinical trials site monitoring and management, both for the external field staff and within the internal GSSO staff.
Work with other POD CD&O leaders to ensure POD CD&O is an efficient, flexible and effective organization operating with the highest quality.
Qualification
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Required
Bachelor’s degree with 15+ years of pharmaceutical/Biotech clinical development experience.
Master’s degree with 13+ years of pharmaceutical/Biotech clinical development experience.
Phd/MD degree with 10+ years of pharmaceutical/Biotech clinical development experience.
8+ years of people management / leadership.
Must have significant experience managing global clinical development Phase I-IV trials, including clinical trial delivery in their relevant region with experience of any regional regulatory directive.
Must have significant regulatory experience spanning Phase I-IV trials, CRO management, direct CRA management, and project and contract management.
Must have Oncology therapeutic experience.
Proven ability to effectively manage a large staff comprised of field-based colleagues and FSP contractors.
Intense drive and organizational expertise are necessary to manage the diverse group of functional activities involved in the international clinical trials program.
Proficiency in GCP/ICH and regulatory issues is essential.
Excellent communication skills and the ability to proactively handle multiple tasks simultaneously are required.
Knowledgeable of basic finance to support Oncology GSSO regional resource and budget management.
Experience and skills in interpersonal / enterprise communications, risk management, planning, stakeholder management, facilitation, conflict resolution, strategic thinking, cultural awareness.
Flexible location requirements (remote / onsite / hybrid).
Able to navigate matrix organizations and influence without formal authority to drive collaboration and build trusted partnerships at all levels.
Able to consistently deliver excellence in an evolving organizational environment characterized by a high degree of uncertainty and change.
Preferred
An advanced degree (Master’s or PhD).
Benefits
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
Company
Pfizer
Pfizer is a biopharmaceutical company that provides affordable access to safe, effective medicines and health care services.
10,001+ employees
H1B Sponsorship
Pfizer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (27)
2022 (55)
2021 (85)
2020 (66)
Funding
Current Stage
Public CompanyTotal Funding
$32BKey Investors
Starboard Value
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B
1978-01-13IPO· nyse:PFE
Leadership Team
Ian Read
CEO
Caroline Roan
Chief Sustainability Officer | SVP, Global Health & Social Impact | President, The Pfizer
Recent News
2024-11-15
thefly.com
2024-11-15
Company data provided by crunchbase
