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, 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.
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.
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.
The Senior DCSO will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership.
When required, contribute to area or global GSSO strategy by leading and participating in area or global initiatives.
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.
Organizational Relationships Partners with local Medical Affairs and colleagues at country and regional level.
Partners with Internal stakeholders to ensure full awareness of Pfizer trial portfolio at country level.
Ensures close collaboration with country and/or regional managers/leadership and key global stakeholders (e. g. , MQA, Regulatory Affairs, CTRO, PharmSci, Legal, Drug Safety Unit, PRD, etc. ).
Partners with Study Team (e. g. , Clinician, Clinical Study team Lead, Study Manager, Data Manager, Project Planner, SUPM), and Country/Regional Study Team Members (Country Operations Manager (SOM), (SAP), (CTA), ICL and their line manager, as needed).
Partners with contracted organizations e. g. , FSP monitoring, and 3rd party vendors as applicable.
Represents Pfizer in key external bodies in support of enhancing the Clinical Trial Environment at Country/Cluster/Regional Level.
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.
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.
DIGITAL TRANSFORMATION STRATEGY One bold way we are achieving our purpose is through our company-wide digital transformation strategy.
We are leading the way in adopting new data, modeling, and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
FLEXIBILITY We aim to create a trusting, flexible workplace culture which encourages employees to achieve work-life harmony, attracts talent, and enables everyone to be their best working self.
Let's start the conversation!
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.
DISABILITY INCLUSION Our mission is unleashing the power of all our people and we are proud to be a disability-inclusive employer, ensuring equal employment opportunities for all candidates.
We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career.
Your journey with Pfizer starts here!
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