Medical Director

Talentify • San Diego, CA, United States • $200k - $250k / year • 3w ago

Medical Director of Oncology Clinical Development

Key Responsibilities:

Serves as a Study Medical Monitor
Author Clinical Trial Documents including protocols, Investigator brochures, ICFs, training materials, and DSURs
Work closely with Clinical Operations to execute clinical trials with high quality, deliver results and meet target timelines
Drive contribution of clinical content for deliverables in support of regulatory submission activities and ensure flow and accuracy of key data for clinical module sections of the IND
Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plan
Contribute to the ongoing scientific review of clinical trial data and assist with query resolution and data analysis
Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data
Maintain scientific and clinical knowledge in the specific oncology-focused therapeutic areas
Stay up to date with internal and external developments, trends, and other areas relevant to the work, maintaining a fully current view
Develop and maintain relationships with a variety of internal and external partners and stakeholders, including clinical investigators, study coordinators/CRAs and KOLs
Review and manage clinical development budgets and provide forecasts to the clinical development and finance team members

Qualifications:

Medical Degree (MD or DO), preferably board certified in medical oncology
5+ years’ experience in clinical development with at least 2 years in the biopharmaceutical industry.
Experience in translational medicine/early phase oncology clinical trials is a plus
Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations
Proven ability to interact and work with external partners (PIs and consultants) with regards to clinical development functions
A solid understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management, and monitoring of investigative sites
Excellent problem-solving skills, a strong sense of urgency and keen attention to detail. Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures
A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required
Excellent oral and written communication skills and strong organizational skills are required
Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes

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