Head of Clinical Operations

Cambridge, Massachusetts, United States Full-time

Evelo Biosciences is seeking an outstanding Head of Clinical Operations

This is an outstanding opportunity to join a fast-paced company leveraging the previously untapped biology of the gut-body network to develop a new class of therapies that could transform the treatment of many major diseases, potentially providing profound benefits to patients and society. Evelo Biosciences is pioneering the development of therapies designed to act on the gut-body network – monoclonal microbials. Monoclonal microbials use naturally evolved pharmacology to work in the gut for effects throughout the body and comprise an entirely new class of potentially effective, convenient and safe medicines to address the unmet needs of huge numbers of patients with serious diseases. As a senior member of the Evelo team, you will play a vital role in creating this new modality of medicine.

We are seeking a Head of Clinical Operations to join a highly dynamic and intellectually challenging team. This key leadership role will afford a qualified candidate an opportunity to work in an innovative, fast paced environment and shape Evelo’s vision to bring new products to patients. 

The Head of Clinical Operations has the overall responsibility for the delivery of the Evelo clinical trial pipeline.  They will be accountable for managing the clinical operations resources ensuring efficient and effective allocation enabling delivery of the immuno inflammation and oncology trials.  The successful candidate will be accountable for developing the plans to build a late stage development capability to come onstream as the first monoclonal microbial therapy reaches phase 3 readiness. The head of clinical operations will work with the immuno inflammation and oncology clinical operations leads to ensure projects are performed within budget, on schedule and in compliance with the appropriate - and quality standards.  The head of clinical operations will be responsible for the development of clinical SOPs with the QA function ensuring Evelo is always inspection ready and compliant with all national and international regulations. 

Primary Responsibilities:

  • Ensure that clinical-stage programs achieve their related objectives and milestones while delivering within established timelines, budget and quality standards, including adherence to ICH, GCP, and all applicable guidelines and regulations
  • Develop, maintain, and report on program budgets, including long-range forecasting and monthly accruals, in support of Evelo’s financial goals
  • Develop the Clinical Operations function to be ready for the execution of late stage clinical development and filing of the first monoclonal microbial.
  • Establish and lead team of internal- and external- multi-functional stakeholders focused on program management and study execution; evaluate and develop ideal outsourcing model for delivery on clinical portfolio, including selection and oversight of CROs and other vendors/ external partners
  • Is a key member of the Evelo senior management team with accountability for all aspects of clinical operations
  • Build and maintain effective relationships with Investigators, Regulatory Authorities and CROs in implementation of study protocols, collaboration on feedback, etc.
  • Design and build a clinical operations organisation that can deliver Industry leading phase 3 programmes
  • Implements, and maintains sound business practices
  • Ability to work in and drive a team-oriented environment, motivate and influence others, lead strategic discussions, and interact with critical internal and external stakeholders, including the Clinical Development Core Team, Principal Investigators, KOLs, CRO partners, patient advocacy groups, and regulatory agencies.
  • Lead the continuous improvement of clinical operations through the establishment of working teams/ initiatives as needed
  • Partner effectively with essential subject matter experts in data management, safety/ pharmacovigilance, clinical supply and CMC, biostatistics, medical writing, quality assurance, regulatory- and medical- affairs

Required Skills/Qualifications:

  • Willingness to travel domestically and internationally (up to 30% of time)
  • Thorough knowledge of drug discovery and development program management, from IND- through BLA, as well as experience in preparation of clinical sections of INDs, BLAs/ MAAs
  • Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA, as well as those defined by international regulatory bodies in specific locations. Thorough understanding of cross-functional processes involved in study design and execution, including protocol development, data management, safety/ pharmacovigilance, biostatistics, medical writing, quality assurance, regulatory- and medical- affairs

Experience and Education:

  • 15 years + experience in clinical operations
  • 3+ years experience in early development
  • 10+ years experience in full development
  • Has been through full submission process
  • 2-5 years in a supervisory role managing clinical operations staff
  • Advanced degree in science or business

 

About Evelo

Evelo Biosciences, Inc. is a clinical-stage biotechnology company developing a new modality of medicine, monoclonal microbials, which are designed to act on the gut-body network. Evelo’s product candidates are orally-delivered, single strains of microbes, selected for their defined pharmacological properties. They are intended to modulate systemic immunology and biology by acting on multiple naturally evolved biological pathways through the gut-body network. Evelo believes that monoclonal microbials have the potential to be broadly applicable across many diseases including immunoinflammatory, cancer, autoimmune, metabolic, neurological and neuroinflammatory diseases.

Evelo currently has three product candidates, EDP1066 and EDP1815 for the treatment of inflammatory diseases and EDP1503 for the treatment of cancer, for which ten clinical readouts are expected during 2019 and 2020. Evelo is also advancing additional candidates through preclinical development in other disease areas.

For more information, please visit www.evelobio.com.

 

 

 

 

 

Apply for this opening at http://evelobio.recruiterbox.com/jobs/fk01bla?apply=true