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Director, Clinical Sciences

Totus Medicines

Totus Medicines

Emeryville, CA, USA
Posted on Friday, May 31, 2024

Totus Medicines is an innovative therapeutic drug discovery biotech that has developed a platform focused on targeted covalent drugs. This novel proprietary platform will enable Totus to deliver candidates against challenging targets in months, not years – 100,000 times faster than competitive technologies and has the potential to expand the spectrum of drug targets to be screened for any disease process.

Totus discovered its first-in-class covalent program in 4 months and entered Phase I in 2023. Totus also plans to expand their platform to create therapeutics targeted at neurodegeneration, infectious diseases, and others. We are searching for talented, passionate, agile candidates to join our team.

The Director will provide strategic input and contribute to the execution of the development and medical affairs plans at Totus. This individual should desire leading or making strategic contributions while demonstrating strong scientific acumen and execution skills in a dynamic, collaborative environment, with opportunity for growth.

Responsibilities:

  • Assists in writing clinical documents and amendments (clinical study protocols, Investigator’s brochure, ICF template) and in the preparation of clinical content for regulatory submissions/documents, in collaboration with other clinical team members
  • Support and contribute to requests for information from health authorities
  • Actively participates in clinical trial investigator feasibility, selection, training and engagement to support clinical trial conduct and compliance, including site initiation and sponsor engagement visits
  • Participates in protocol training for study sites, study vendors and CRO staff
  • Partners with data management to develop eCRFs, data review plan and reviews subject and cumulative data per the data review plan, and coordinates with others for study level review; escalates questions to appropriate team members
  • Participates in interpretation and presentation of study results, including contributing to Clinical Study Reports
  • Supports the preparation, review, and submission of clinical publications and presentations
  • Leverage and manage vendors to support medical and scientific affairs deliverables
  • Lead or contribute to clinical development strategy and execution of advisory boards
  • In collaboration with CMO, develops and drives scientific communication strategy, ensuring alignment with company strategy and cross-functional partners
  • Provide updates relating to emerging data in the scientific literature
  • Works closely with Medical Monitor to review patient eligibility and manage patient safety on clinical trials
  • Other duties as assigned

Requirements:

  • MD, PhD, or PharmD degree
  • 3+ years of drug development or medical or scientific affairs experience or equivalent clinical research experience at CRO or academic institution
  • Oncology experience is preferred
  • Ability to work independently
  • Strong understanding of GCP, clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology
  • Ability to collaborate with cross functional colleagues at all levels of to coordinate/execute study activities
  • Proficient at clinical data review including query generation and management and data presentation to both internal and scientific audiences
  • Demonstrated strong scientific acumen and desire to expand knowledge, expertise, and experience
  • Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
  • Ability to travel as needed (15 – 25%)

Compensation Range:

Director: $189,000 - $243,800