Full-Time

Head of Clinical Operations

Posted on 5/29/2024

Flagship Pioneering

Flagship Pioneering

501-1,000 employees

Biotechnology firm creating health and sustainability solutions

Venture Capital

Senior, Expert

Cambridge, MA, USA

Required Skills
Communications
Requirements
  • Advanced degree in life sciences or related field
  • Minimum of 10 years of relevant industry experience in clinical operations
  • Solid understanding of US and global regulations and guidelines
  • Experience and skillset selecting and managing CROs, vendors and/or clinical trial consultants
  • Experience with alliance management
  • Ability to interpret and integrate scientific and clinical data
  • In-depth knowledge of global clinical trial regulations and guidelines
  • Strong strategic thinking, decision-making, and problem-solving skills
  • Excellent written and oral communication and people skills
  • Remote/hybrid role possible; Local highly preferred
Responsibilities
  • Lead clinical operational strategy for assets across multiple therapeutic areas
  • Manage all operational aspects of clinical trials from study concept through regulatory submissions
  • Drive the design and execution of clinical development plans
  • Oversee relationships with CROs and third-party vendors
  • Identify innovative opportunities in study start-up
  • Coordinate study objectives/protocols, timelines, and resource requirements
  • Develop and manage the clinical operations budget
  • Collaborate with KOLs on development plans and study protocols
  • Identify potential risks and develop mitigation plans
  • Represent the company at conferences and regulatory engagements
  • Present regularly to the executive team and Board of Directors

Flagship Pioneering fosters a culture of groundbreaking advancements in biotechnology, emphasizing an ecosystem approach that synergizes human health and sustainability. Their business model not only focuses on creating transformative products but also incubates leading companies like Moderna and Indigo Agriculture, positioning them at the forefront of scientific innovation and industry leadership. This approach offers employees a unique opportunity to be part of a pioneering team that drives real-world impacts across multiple sectors.

Company Stage

N/A

Total Funding

$6.4B

Headquarters

Cambridge, Massachusetts

Founded

2000

Growth & Insights
Headcount

6 month growth

10%

1 year growth

19%

2 year growth

45%