Senior Director Clinical Site Operations

4 settimane fa

Rome, Italia Pfizer A tempo pieno
Senior Director Clinical Site Operations

JOB SUMMARY

  • Reporting to the Head of Site & Country Operations, the Pfizer Oncology Division (POD) Senior Director of Clinical Site Operations (Senior DCSO) is a dynamic leader supporting the Head of Site & Country Operations to deliver their strategic vision and representing POD operations at the country or cluster level.
  • Represents POD at the country or cluster level playing a critical role establishing and cultivating relationships with KOLs, strategic sites/ networks, HAs/governments and industry clinical research associations to become the Face of Pfizer and positioning Pfizer as a partner of choice within their country/cluster.
  • Supports and cultivates a collaborative partnership with Medical Affairs, creating a framework for an end-to-end continuum linking investigator relationships to future prescribers within the country.
  • The Senior DCSO influences leadership decisions that impact business, will build and leverage constructive internal relationships within POD and PRD, to drive strategic initiative/success.
  • Demonstrated knowledge and understanding of the local marketplace, and industry trends, providing insights and enabling teams to successfully position and deliver oncology clinical trials.
  • Leads the GSSO organization within their country/cluster to deliver the Pfizer oncology portfolio, 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.
  • The Senior DCSO may sponsor, chair, or lead operational strategic initiatives, to accomplish business objectives that are multifaceted and unique in complexity. Also encompassing and empowering an extensive team / line management, mentoring and coaching duties.

JOB RESPONSIBILITIES

  • The Senior DCSO is accountable for ensuring appropriate Site Care Partner (SCP), and Site Monitor resources are in place to deliver on, country and site-level end to end activities in-line with study milestones in the designated countries/clusters. This role provides line management and oversees the Site Care Partner and Site Monitor ensuring compliance with training requirements. The Senior DCSO is accountable to ensure overall monitoring, operational site partnership, management and oversight activities within a designated country/cluster 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.
  • Overall accountability for the Growth and Development of the Site Operations organization (Managers and Individual Contributors) and to ensure compliance with training requirements.
  • Partner with the FSP Manager of Site Care Partner & Site Monitors as described in standard contracts with the FSP.
  • Accountable for country/cluster budget in accordance with financial expectations.
  • Demonstrate leadership in the resolution of site/country/cluster issues to ensure project delivery, patient safety, quality and maintain investigator site relationships.
  • This is a strategic role that coordinates cross functionally with Study Start Up, Operational Analytics and Quantitative Sciences (OARS), Patient Recruitment and Study Management, providing local knowledge and critical input to country and site selection.
  • Collaborate with country regulatory/regional Clinical Trial Regulatory operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their country/cluster.
  • The Senior DCSO represents Pfizer Oncology Divisions (POD) as the operational partner for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster 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 responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders.
  • Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection and ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.
  • The Senior DCSO will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership.
  • The Senior Director of Site operations is a Subject Matter Expert (SME) on country/site management.
  • As applicable, act as the POD representative on Country Medical Councils to ensure transparent communication within relevant Pfizer stakeholders in the cluster/country.

Basic Qualifications

  • 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 be fluent in English. Local language capabilities are an advantage in this role
  • Availability to travel up to 50% of time.

Skills

  • Demonstrated People management experience
  • Ability to lead and manage diverse teams.
  • Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities.
  • Ability to lead and influence a matrix environment, capable of driving initiatives across GSSO.
  • Demonstrated understanding of People Experience (PX) procedure and policies at global and local level.
  • Demonstrated ability to navigate the right stakeholder internal and externally for the required escalation when appropriate and resolve issues in a timely manner.
  • Ability to lead change with can-do attitude and support team to go through change management cycle.
  • Demonstrated ability to engage with senior stakeholders internally and externally to the organization.
  • Ability to work effectively with line support functions including finance, PX across the region.
  • Ability to effectively coach and train direct reports including management of escalated issues from sites/investigators, and development of core competencies.
  • Agility to adapt to VUCA (Volatility, uncertainty, complexity and ambiguity)/evolving environment.

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve.

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