Company Overview

This is a pharmaceutical company that focuses on orphan and autoimmune diseases.

Position Title: Clinical Development Sciences Operations Manager (#2204-5753)

Therapeutic Area: Hematological Disorders

The Operations Manager is responsible for full strategic and administrative program-level and project-level support of the Clinical Development Sciences function, working closely to support Clinical Development Sciences sub-team leaders, Clinical Operations, Biometrics, and Data Management and coordinating with other key functional areas involved in drug development.

Essential Duties and Responsibilities

  • Establishes detailed Clinical Development Sciences program and project plans, including activities, timelines, staffing resources, and budgets in alignment with the overall development programs and company goals.
  • Maintains strategic program timelines for clinical development activities, flagging and tracking rate-limiting activities.
  • Coordinates data cuts to support program goals, including interim analyses, safety monitoring committees, database lock, and public disclosure.
  • Identifies development-level risks, facilitates mitigate planning, and maintains risk logs.
  • Facilitates Clinical Study Team meetings and other meetings, including responsibility for agendas and meeting minutes.
  • Ensures Advisory Boards and/or Scientific Conferences are planned and executed to facilitate program advancement in coordination with functional area experts.
  • Coordinates and maintains a budget for departmental attendance at scientific and career-development conferences and training.
  • Updates and maintains early study forecasts to enable proper planning for resource allocation, with input from relevant functional leads, to ensure consistent assumptions and expectations and facilitate executive-level reporting. 
  • Develops and maintains resourcing spreadsheet to ensure the appropriate level of staffing available for all phases of development, including planning, start-up, maintenance, lock, Regulatory filings, and post-approval. 
  • Coordinate with project management and vendors to ensure the timelines are consistent across stakeholders for clinical functions
  • Ensures effective communication collaboration and documentation of all Clinical Development Sciences aspects of the program, including preparation of reports and clinical-specific regulatory filings such as CTAs.
  • Other duties as assigned.

Qualifications (Education & Experience)

  • Bachelor’s degree is required, preferably in a scientific field preferred. Masters or PhD preferred.
  • A minimum of 7 years of experience in the biopharmaceutical industry, including Early Drug development management throughout the development process.
  • Broad understanding of all aspects of drug development, including preclinical, clinical, safety, regulatory, and quality requirements globally.
  • Strong project management skills, exceptional problem-solving skills, and ability to discern critical aspects of operations.
  • Proactively ensures departmental deliverables are met with the highest level of data integrity and subject safety.
  • Proven experience in managing programs, budgets, and resources.
  • Demonstrated ability to see beyond own function to understand business issues and implement best practices.
  • Outstanding planning, communication, and collaboration skills, including leading teams with cross-functional scope.
  • Proven ability for strategic thinking in a complex business environment.
  • Ability to successfully function in a rapidly changing environment.
  • Strong interpersonal communication skills.
  • Fosters excellence throughout the organization.

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.

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