Totus Medicines, an innovative therapeutic drug discovery biotech, is just emerging from stealth. With a $40M Series A, Totus is poised to revolutionize drug discovery. For the first time, Totus is enabling genome-scale drug discovery to allow the identification of precision medicines for hard-to-drug targets. At its core, Totus is a chemical biology company. Totus’ novel proprietary platform allows screening at a rate more than 100,000 times faster than competitive technologies. Totus has pioneered the development of selective medicines for patients with genetically defined cancers and plans for its first program to enter Phase I by end of 2022. Totus also plans to expand their platform to create therapeutics targeted at neurodegeneration, infectious diseases, and others. We are searching for talented, passionate, high-energy candidates to join our growing team.

Summary:

The Senior Clinical Program Manager is accountable for oversight of clinical program(s) and leading day-to-day operations of one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. This activity is typically coordinated in conjunction with one or more CROs. This position will report to the Vice President, Clinical Operations.

Responsibilities:

  • Oversee all aspects of clinical trials to ensure trials are executed and completed on time, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines, with minimal supervision
  • Facilitate operational activities in coordination with contracted CRO/vendor(s) pertaining to the execution of Ph I-III clinical trials from study start through close-out
  • Primary contact for cross-functional area representatives (including consultants) and vendors responsible for protocol execution
  • Management and oversight of CROs, service providers and consultants that are involved in assigned studies.
  • Develops and coordinate reviews of study protocols, informed consent forms, case report forms, study plans, clinical study reports, study materials and tools, and regulatory documents (e.g. IND, NDA, etc.)
  • Contributes to and owns development of presentations, manuscripts, and abstracts, in collaboration with Clinical Development
  • Ensures accurate tracking and reporting of study progress
  • Lead CRO and vendor selection and onboarding process, including initiation RFPs, coordinates bid defenses and selection process, facilitates contracts and training
  • Develops, tracks and maintains study budgets and timelines
  • Communicates project status and issues and ensure project team goals are met
  • May conduct site visits (in conjunction with CRO) for oversight, site evaluation, initiation, monitoring, or close-out activities
  • Participates in selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
  • Coordinate and participate in data cleaning activities, data listings review, and preparation of Clinical Study Reports
  • Plan and coordinate Investigator Meetings
  • May mentor and manage more junior level staff and support their professional development
  • Contributes to department operations, including development/review of new and existing SOPs and participation in identification and implementation of clinical operations process and system improvements

Requirements:

  • Bachelor’s degree, preferably in a scientific field
  • A minimum of 8+ of Clinical Study Management experience at a Sponsor or CRO, preferably in oncology
  • Thorough understanding of ICH GCP guidelines
  • Understanding of clinical trial processes (e.g., data management, safety reporting, biostatistics, medical writing) and experience in driving execution, from study start-up through study closure
  • Strong foundation in the management of CROs, vendors, investigative sites, and external resources
  • Experience in all phases of a clinical trial, from study start-up to study close-out activities
  • Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
  • Self-motivated, assertive, and able to function independently or as part of a team
  • Flexibility and willingness to step in and be a team player in a collaborative environment
  • Strong problem-solving skills with the ability to work in a fast-paced environment with multiple competing timelines
  • Previous experience leading junior team members and mentoring those individuals

What We Offer

  • A knowledgeable, high-achieving, experienced and fun team

  • A diverse work atmosphere

  • The chance to be part of a growing startup and the next success story

  • The opportunity to shape our company culture

  • Constant learning and dynamic challenges to help you grow and be the best version of yourself

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