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Pod Vp Head Of Row Site

2 mesi fa

Lazio, Italia Pfizer, S.A. De C.V A tempo pieno

POD VP Head of ROW Site & Country Operations We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Reporting to the Head of Oncology Global Study and Site Operations (GSSO), the Pfizer Oncology Division (POD) VP Head of Site & Country Operations will be accountable for establishing the strategic vision and short to long term planning for POD Operations within their region.
Represents POD at the regional level playing a critical role building relationships with KOLs, strategic sites/networks, HAs/governments and industry clinical research associations to become the Face of Pfizer Oncology and positioning Pfizer as a partner of choice for their region.
Demonstrated knowledge and understanding of the external marketplace, and industry trends, performing impact analysis and strategic action planning in anticipation of POD requirements.
Accountable for leading the GSSO organization within Americas or ROW to ensure world-class clinical development delivery of the Pfizer oncology portfolio within their regions, driving a meaningful increase in patient recruitment whilst meeting and exceeding speed and quality deliverables and best in class cycle times to bring medicines to patients faster.
Accountable to establish and cultivate a collaborative partnership with Medical Affairs, creating a framework for an end-to-end continuum linking investigator relationships to future prescribers.
Partners, negotiates, and influences across local, regional and global Pfizer business lines influencing POD strategy and decisions and then delivers from the best positioning on quality, cost-effective operational excellence.
Sponsor, Lead, and/or Support investigator site and vendor partnerships to design and shape short- and long-term innovation strategies incorporating decentralization, diversity and digitization solutions. Success in this role requires a strong understanding of clinical development processes and procedures, as well as experience in risk management, planning, stakeholder management, facilitation, conflict resolution, strategic thinking, and cultural awareness.
ROLE RESPONSIBILITIES
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 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.
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.
ORGANIZATIONAL RELATIONSHIPS
Reports to Head of GSSO • Member of GSSO Leadership Team • Directly manages country resources, as appropriate • Manages external relationships with strategic partners • Manages internal relationships with country leadership, country and regional managers, country medical directors, asset leads and POD medical teams. • Works closely with COH/ SMGLs to support and build program strategies
QUALIFICATIONS / SKILLS
In general, candidates for this job should have the following levels of experience:
Bachelor's or Master's degree or PhD/MD degree with extensive pharmaceutical/Biotech clinical development experience.
Proven 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 QUALIFICATIONS
An advanced degree (Master's or PhD).
ADDITIONAL REQUIREMENTS
Ability to travel up to 50% of time.

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