Clinical Operations Leader

Role & Responsibilities of the Clinical Operations Leader at Nimbus

Reporting to our Vice President, Clinical Operations, the Clinical Operations Leader will be a critical member of Nimbus’ growing Development organization. This position will support the operational aspects of our clinical studies by providing expertise, creative thinking, and direction to ensure successful delivery for one or more clinical programs.

More specifically, this position will:

  • Lead cross-functional teams to ensure delivery of complex clinical trials and manages protocol execution.
  • Oversee CROs and vendors to ensure timelines, goals and deliverables are met with quality, within budget, and in accordance with SOPs, GCP and all applicable laws and regulations.
  • Contribute to the clinical development plans and strategies, including protocol development.
  • Collaborate with Regulatory on drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, CSRs and other FDA submissions.
  • Perform ongoing review and analysis of study safety and efficacy data.
  • Perform literature searches and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
  • Responsibility for other project and/or operational tasks, as they arise.

The Qualifications We Are Seeking

  • Bachelor’s degree in a life science or a health-related field, advanced degree preferred.
  • Minimum of 8 years of experience in a pharmaceutical industry or CRO environment in clinical operations, clinical development, or medical affairs, preferably in oncology and/or immunology.
  • Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and other research vendors.
  • Strong understanding of FDA/ICH guidelines and industry standard practices regarding clinical trial management.
  • Excellent management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams.
  • Demonstrated ability to comprehend and communicate complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
  • Ability to navigate, problem-solve, and execute in a dynamic and evolving environment.
  • Ability to navigate, problem-solve, and execute in a dynamic and evolving environment.

A Snapshot of Nimbus

Nimbus is a ~ 40 person, biotechnology company located in the thriving biotech hub of Cambridge, Massachusetts. We transform drug development by integrating computational drug discovery techniques, a cutting-edge computational chemistry platform and other advanced technologies to design breakthrough medicines for patients.

We focus on promising targets in metabolic disease, oncology and inflammation. These include both emerging and well-validated targets that have proven intractable to others in the pharmaceutical and biotechnology industry.

Nimbus offers a fast-paced, entrepreneurial, team-focused work environment. The culture is intellectually stimulating, flexible and results-oriented.  Joining our team offers significant opportunities to grow professionally and personally.

We also offer a top-notch benefits package (health, dental, life, vacation, and employer 401K contribution). Being part of Nimbus (a Nimbi, if you’re curious), allows you to become part of a small close-knit professional team that strives to bring out the best in each other by working hard and having fun together.

We are making a difference and you can too.

Nimbus is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.