Head of Clinical Development Operations

Company: The American College of Radiation Oncology
Location: Cambridge
Posted on: February 16, 2021

Job Description:

Vice President*, Clinical Development Operations Become Part of the BioNTech Family.

Based in Cambridge, MA,--BioNTech US--serves as BioNTech's North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech's highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech's growing presence in the US.

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project "Lightspeed" based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
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We aim to achieve life-changing successes for patients by being innovative, passionate and united,so get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

BioNTech is seeking a leader for global development operations activities to oversee functional areas and service lines supporting numerous clinical development programs for multiple products.
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The US-based (Senior) Vice President, Clinical Development Operationswill serve a key strategic role building and leading the global clinical development operations at BioNTech. This senior leader will be accountable for the overall operational execution team performing clinical development of BioNTech`s assets. This role will be responsible for building an organization that can plan and manage the clinical development of several products and programs from IND/CTA to initial regulatory approval and supplemental approvals.

The VP will be the senior operations executive and will have the opportunity to define the operational systems and strategy for a multi-billion-dollar organization developing several cutting-edge and personalized medicine technologies. Here, you'll achieve greatness. Supporting BioNTech's clinical operations and drug discovery in the US by:

• Build a team and organization (integrating teams in Germany and US) capable of executing against Clinical Development Plans and Target Product Profiles for numerous innovative drug and biologic programs for cancer, rare diseases, and infectious. This team will specifically involve following functions:
  • Clinical trial set up & management,
  • CRO management & oversight, clinical trial sourcing,
  • clinical trial data sciences & data management,
  • IMP management/trial supply.
  • Safety and Risk management
  • Lead a team developing processes, systems, and tools to implement clinical development strategy for all BioNTech products/programs.
  • Establish processes and interfaces to coordinate with relevant functions (including but not limited to clinical program leads, regulatory affairs, scientific/medical writing, pharmacovigilance, project management, QA GCP, Biomarker data science) to ensure that Clinical Development Operations is effectively delivering high-quality clinical research/development activities in support of all clinical development programs.
  • Ensure corporate-level delivery of all technical support related to production of clinical development program materials internally and by CRO vendors and other external suppliers.
  • Ensure BioNTech teams and vendors working on co-developed assets are meeting the terms of the co-development agreements including compliance with partnership obligations for all technical and operational deliverables.
  • Oversee a team providing management of and direction to global CRO personnel working on clinical trials of all BioNTech products/programs.
  • Ensure that BioNTech project teams are managing the performance of all vendors to ensure compliance with all contractual and regulatory obligations, including on-time and on-budget service delivery.
  • Engage with CRO personnel for project/program governance.
  • Take a key role in steering design and implementation of concepts, systems, processes for digital transformation of areas that are critical for clinical development operations Requirements
    • MD and/or PhD is highly preferred; Bachelor's required
    • Significant experience as a senior leader managing, mentoring and developing clinical development/operations team members
    • Significant experience with designing organizational functions, and building out departments and teams
    • Broad experience with--NDA/BLA/MAA submissions
    • Significant experience collaborating and partnering with FDA/EMA/global authorities
    • Significant strategy development and execution
    • Experience with biologics is required
    • Experience with oncology, immunology, immuno-oncology and vaccines highly preferred
    • Personal ethical integrity and a commitment to improving the outcomes for patient Job Information
      • Job ID: 55716063
      • Location:
        Cambridge, Massachusetts, United States
      • Position Title: Head of Clinical Development Operations
      • Company Name: BioNTech US
      • Job Function: Clinical,
        Operations
      • Job Type: Full-Time
      • Job Duration: Indefinite
      • Min Education: Ph.D.
      • Min Experience: 1-2 Years
      • Required Travel: 0-10% Jobs You May Like Clinical Group Head Cambridge, Massachusetts, United States Head of Drug Safety Cambridge, Massachusetts, United States CT Senior Manager/Associate Director, Clinical Supply... C4 Therapeutics Watertown, Massachusetts, United States S 2001 6th Ave, Suite 2700 Seattle, Washington 98121 (206) 956-3650

Keywords: The American College of Radiation Oncology, Cambridge , Head of Clinical Development Operations, Healthcare , Cambridge, Massachusetts