Odonate Therapeutics
Published
March 23, 2020
Location
Massachusetts, United States of America
Job Type
Work Setting
Remote / Home-based

Description

The Senior Director, MD Clinician is responsible for strategic clinical relationships with investigators and sites related to Odonate’s clinical trial programs, review of clinical safety and efficacy data for assigned projects and contribution to internal planning related to clinical development, commercial and regulatory planning. The Senior Director, MD Clinician will report to the Chief Medical Officer and collaborate closely with all functional lines including but not limited to Clinical, Regulatory, Commercial, Market Access, Pharmacovigilance and Quality Assurance. Our ideal candidate will have formal oncology clinical training as well as pharma experience with an established track record of progressive achievement in a clinical development environment.

Essential Duties and Responsibilities

  • Develop and maintain key strategic relationships with investigators participating in Odonate clinical studies
  • Support activities related to clinical study sites including participation in site initiation visits, face-to-face meetings with investigators and response to site study 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 Medical, Biometrics and Clinical Operations
  • Undertake clinical 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 for the timely and accurate reporting of serious safety events
  • Provide consultation and training to internal Odonate team members, CRO, vendor partners, investigator site personnel and others as required
  • Attend all Investigator Meetings, Regional or International Conferences, Odonate “All Company” meetings, as well as frequent travel to sites as required
  • Maintain compliance with Odonate’s policies and procedures

Qualifications

  • Medical Degree required; oncology and pharma-experienced PharmD may be considered
  • Minimum 5 years of experience within the pharmaceutical industry
  • Minimum 3 years of experience working directly on oncology clinical trials required
  • Specialty training in oncology required
  • Clinical practice experience in oncology strongly preferred
  • 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 quickly build rapport and credibility with key external stakeholders
  • Strong oral and written communication skills to interact with internal and external stakeholders
  • Must be willing and able to travel domestically and internationally up to 50%
Apply
https://www.linkedin.com/in/your_name/
Drop files here browse files ...
Resume, cover letter, or other documents as required per the job description

Related Jobs

Are you sure you want to delete this file?
/