Position Summary

The Director, Clinician Scientist is responsible for review of clinical safety and efficacy data for assigned projects and contribution to internal planning related to clinical development, commercial and regulatory planning. The Director, Clinician Scientist will report to the Chief Medical Officer and collaborate closely with all functional lines including but not limited to Clinical Operations, Safety and Pharmacovigilance, Data Management, Regulatory and Quality. This individual is expected to assist with review and authoring of clinical sections of regulatory documents (IB, Annual Reports, IND sections and CSR). Our ideal candidate will have formal training in biology or a related field as well as pharma experience with an established track record of progressive achievement in a clinical development environment.

Essential Duties and Responsibilities

  • Support activities related to clinical study sites including participation in site initiation visits, face-to-face meetings with investigators and response to site questions regarding clinical trial implementation and patient treatment
  • Participate in data review to support the accurate assessment of study drug benefit and risk, in collaboration with Clinical Operations, Safety and Pharmacovigilance, Data Management, Regulatory and Quality
  • Undertake support of sites in relation to patient safety including appropriate patient enrollment, optimal prevention management of drug adverse events and evaluation of emergent safety events
  • Partner with Safety and Pharmacovigilance to ensure accurate reporting of serious safety events and reconciliation between safety and clinical databases
  • Assist with review and authoring of clinical sections of regulatory documents (IB, Annual Reports, IND sections and CSR)
  • Develop and maintain key strategic relationships with investigators participating in Odonate clinical studies
  • Undertake review and provide input to operational strategy and feasibility of clinical protocols and study plans and documents, including but not limited to informed consent forms
  • Provide consultation and training to internal Odonate team members, CRO, vendor partners, investigator site personnel and others as required
  • Develop and contribute to SOPs as requested
  • Attend Investigator Meetings, Regional or International Conferences, Odonate “All Company” meetings, as well as travel to sites, as required
  • Maintain compliance with GCP and Odonate’s policies and procedures 

Qualifications

  • Bachelor’s Degree required, preferably in a Life Sciences discipline
  • Minimum 5 years of experience within the pharmaceutical industry required
  • Minimum of 3 years of experience working directly on oncology clinical trials required
  • Experience in solid tumors preferred
  • Knowledge and understanding of ICH and GCP guidelines
  • In-depth understanding and experience with study methodology, protocol design, safety evaluation and data analysis 
  • Ability to effectively engage and influence internal and external leaders, solicit information, persuade others and shape outcomes
  • Global mindset and proven ability to partner regionally and cross-culturally
  • Excellent interpersonal skills to enhance achievement of Odonate’s corporate objectives 
  • Effective written and verbal communication skills with the ability to communicate clearly and concisely
  • Must be willing and able to travel domestically and/or internationally up to 20% 

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