Executive Medical Director, Clinical Development

Location United States
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Salary: On application
Contact name: Lucy Psaltis

Contact email: lucy.psaltis@rbwconsulting.com
Contact phone: +1 (617) 982 1238
Job ref: 20596
Published: 29 days ago
Expiry date: 12 April 2021

​Location: San Francisco Bay Area, USA

An extremely opportunistic time to join a global biopharma with oncology drug candidates across all phases of development. My SF-based client requires medical support within their clinical development department to contribute to their innovative approach in combination and immunotherapies for various cancers. In addition to the research and development they are advancing in the East, their US pipeline includes 5 clinical-stage assets, both novel and targeted, which take them closer to the goal of becoming global leaders in the development of medicines for cancer patients. They are currently pre-IPO and experiencing great success and funding which will bring them public next year, 2021, making this opportunity all the more stimulating as well as extremely lucrative.

With such success, they require developmental support and are seeking an Executive Medical Director to report to the CMO in the greater San Francisco Bay area. You will be responsible for all aspects of development of Phase 1-3 clinical trials and will work closely with the Clinical Operations team. This will be a highly strategic and hands on role, and prior leadership experience as well as a strong background in oncology clinical development across all phases is required.

Responsibilities:

  • Manage the process for the company’s clinical studies effort to ensure success, scientific integrity/accuracy and ethical conduct of clinical protocols, investigator brochures, FDA/Health Authority review, and clinical study reports; act as medical monitor.

  • Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates.

  • In conjunction with clinical development staff, direct and oversee clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board/Ethics Committee applications, training, monitoring, documentation, and data analysis.

  • Review and approve procedures for the design and implementation of clinical protocols, data collection systems and final reports.

  • Ensures clinical studies are appropriately designed, effectively executed and monitored.

  • Provide safety surveillance guidance and acts as a medical monitor

  • Manage outside consultants/vendors to ensure data is accurately collected and analyzed in a cost-effective fashion.

  • Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies

  • Conduct literature reviews, prepare summaries support clinical development programs

  • Prepare manuscripts, abstracts and presentations for scientific meetings.

Qualifications:

  • M.D. required. Board certification or eligibility in Hematology/Oncology preferred.

  • At least 3+ years of clinical development experience in the biopharma industry

  • Demonstrated outstanding leadership of multiple development projects and can work effectively with other clinical and scientific leaders.

  • Experience in the design, conduct, analysis, and reporting of clinical studies, including experience submitting NDAs/BLAs to regulatory authorities in the US and Europe.

  • Strategic agility; outstanding judgment and decision-making skills; strong interpersonal, influencing, presentation, and written and verbal communications skills.

  • Willingness and ability to travel.

Please apply with an updated CV and reach out to lucy.psaltis@rbwconsulting.com / 617-982-1238 for more information.

Salary: On application