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Full-Time

Clinical Study Team Lead

Obesity, Director

Confirmed live in the last 24 hours

Pfizer

Pfizer

10,001+ employees

Develops and manufactures vaccines and medicines

Biotechnology
Healthcare

Compensation Overview

$161.6k - $269.4kAnnually

+ Bonus

Senior, Expert

Remote in USA + 1 more

More locations: Groton, CT, USA

Relocation support available.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • Bachelor’s degree (BS/BA) in science, health-related field or epidemiology, or a discipline related to drug development or business required
  • 10+ years of relevant experience (prior clinical trial, non-interventional study and/or epidemiologic study)
  • Extensive experience in conduct of multiple obesity clinical trials and clinical trial operations with glucagon-like peptide-1 (GLP-1) agonists and/or glucose-dependent insulinotropic polypeptide (GIP) compounds required.
  • Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise)
  • Demonstrated project management and cross-functional leadership experience associated with project and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations required
  • Demonstrated experience in understanding key drivers impacting budgets, building Clinical Trial Budgets and managing project to budget
  • Demonstrated breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
  • Strategic thinking and targeted problem-solving skills
  • Exceptional communication and interpersonal skills
  • Ability to lead cross-functional teams, identify, resolve, and escalate issues
  • Ability to influence and collaborate with peers
  • Ability to leverage, negotiate, and resolve conflicts to enhance team performance and delivery
  • Ability to represent & communicate clearly to senior leaders and governance bodies
  • Ability to understand and assimilate high-level data from all functions
Responsibilities
  • Lead study teams and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets and quality targets to meet or exceed business needs
  • Accountable for strategic planning and decision making at the study-level in line with program objectives
  • Represents the study team at appropriate medicine team and sub-team discussions
  • Partner and collaborate with functional line leadership to ensure optimal resourcing of the study teams
  • Drive functional lines to ensure inspection readiness; ensure maintenance and accuracy of Standard Operating Procedures (SOP) log
  • Maintain active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensure appropriate prioritization and management of events through to resolution
  • Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team performance and be accountable for effective study team operations
  • Accountable for issue escalation and resolution
  • Lead study team chartering and team health check process
  • Drive proactive planning to navigate the team through governance and decision point milestones to support on-time delivery of study to maintain development timelines
  • Develop and lead execution of data and document delivery plans at key milestones such as Proof of Concept and Phase 3 decisions
  • Lead preparations for and present the study to relevant governance per organizational norms and expectations
  • Proactively identify operational issues and lead the teams in identifying options to de-risk and capitalize on opportunities
  • Lead the study teams in proactive problem solving, management and communication of risk management plans including risk assessment and mitigation strategies
  • Act as a single, authoritative source of study information and lead study-level status reporting per organizational norms and expectations; ensure systems are maintained with up-to-date program status, risks, and issues
  • Oversee operational metrics across study(-ies) and partner with functional lines to manage trends
  • Accountable for managing overall submission of Clinical Development & Operations sub-team timelines, budgets, and quality targets
  • Ensure comprehensive operational input to submission plan
  • Lead cross functional Module 2/5 submission sub-teams with accountability for delivery and overall operational strategy to ensure data and document delivery to support submissions and rapid response. Manage other submission activities as necessary
  • Oversee operational metrics across submission sub-teams and manage trends and escalations

Pfizer is a biopharmaceutical company that focuses on creating and manufacturing healthcare products, including medicines and vaccines. The company conducts extensive research and development to discover new treatments, which are then commercialized and sold to various clients such as governments, healthcare providers, and patients. Pfizer's products include vaccines, oncology treatments, and specialized medicines. A notable achievement is its partnership with BioNTech to develop a vaccine for COVID-19, which has played a significant role in addressing the pandemic. Pfizer aims to improve public health by providing access to vaccines, especially in underserved areas, and continues to grow its product offerings with new approvals and treatments.

Company Stage

IPO

Total Funding

$3.8B

Headquarters

New York City, New York

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
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Simplify's Take

What believers are saying

  • Pfizer's significant investments in companies like CellCentric and Caribou Biosciences indicate a strong focus on expanding its oncology and cell therapy capabilities.
  • The company's proactive approach in securing investments and partnerships positions it well for future growth and innovation in the biopharmaceutical sector.
  • Pfizer's involvement in funding rounds for promising biotech firms suggests potential for lucrative returns and strategic advancements in healthcare solutions.

What critics are saying

  • The slowdown in demand for COVID-19 vaccines could impact Pfizer's revenue and market perception.
  • Activist investor involvement, such as Starboard Value's $1 billion stake, may lead to pressure for strategic changes that could affect company stability.

What makes Pfizer unique

  • Pfizer's strategic partnerships and investments in innovative biotech companies like Promise Bio and Enara Bio highlight its commitment to cutting-edge research and development.
  • The company's collaboration with BioNTech for the COVID-19 vaccine showcases its ability to rapidly respond to global health crises, setting it apart from many competitors.
  • Pfizer's diverse portfolio, including oncology and specialized medicines, ensures a broad market reach beyond just vaccines.

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