Position Summary

Reporting to the Senior Vice President of Clinical Development, the Director, Global Study Lead (GSL) will be a key member of the Rakuten Medical Inc. (RMI) Clinical Operations Team. The GSL will function as the product team leader to plan, organize, and coordinate all operational aspects of a global multi-regional clinical study from protocol development through database lock while ensuring timelines for different regions are fulfilled.

The GSL will ensure timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and all applicable regulations governing the conduct of clinical trials while meeting Company goals and objectives.

The GSL will be a roll-up of the sleeves to get the job done team member, work with a sense of urgency, attention to details, and work with utmost integrity in a fast-paced small biotech environment.

Key Duties and Responsibilities

• Responsible for the implementation and quality execution of assigned clinical projects according to RMI SOPs, ICH/GCP and corporate and departmental program goals.
• Lead global timelines and budget management to optimize achievement of study goals and milestones.
• Lead Clinical Research Organizations (CRO)/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions. Includes review of Scope of Work, budgets and negotiating contracts through execution in a timely manner.
• Ensure quality and timely delivery of clinical study data.
• Chair or participate in global meetings or conference calls with multi-disciplinary study team across multiple time zones/countries/regions, regional monitors, or vendors (e.g., CROs, central Labs).
• Coordinate activities with other functional groups, such as Regulatory, Drug Safety, Biostatistics, Supply Chain, etc.
• Work with CROs to define and ensure the coordination of Sponsor and CRO responsibilities, obligations are being met in a timely manner.
• Lead the team developing critical study documents, including, but not limited to informed consent form templates, various management plans and study trackers.
• Maintain strong relationships with site study personnel to ensure site engagement.
• Monitor global site performance on an ongoing basis and escalate any infringements, breaches and misconduct, fraud, and negative trends.
• Ongoing protocol deviation tracking, reporting, and trending.
• Collaborate with the Quality department in the auditing of clinical trial site data for accuracy and consistency and arrange correction of errors as appropriate.
• Remain current with ICH guidelines, FDA regulations, and company SOPs May contribute to the identification and development of departmental policies.
• May recommend and implement innovative processes to improve and impact clinical trial management and deliverables.
• Lead or support GCP inspection-readiness activities.
• Present at Cross-functional meetings, Vendor Meetings, Leadership forum, and Investigator Meetings.
• Be proficient using Microsoft Office tools (MS word, excel, power point) to provide regular updates and action items.
• Travel up to 25% (domestic and International) to regional offices, visit study sites, and meet PI/ site staff.

Desired Education, Skills and Experience

• BA/BS in related life science field required, Master’s degree preferred e.g. nursing, or health related field.
• 8 or more years of relevant experience managing clinical programs. Prior study coordinator or CRO experience is a plus.
• Global drug experience in oncology drug development.
• Experience in CRO selection and management including drafting requests for proposals (RFPs), bidding process, vendor negotiations etc.
• In-depth knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
• Success working within a team and independently, with minimal supervision.
• Strong organizational/prioritization of multiple tasks under tight timeframes with close attention to detail in a global environment.
• Excellent communication and interpersonal skills.
• Excellent computer skills.
• Advanced degree desired.
• Experience with Global Phase 3 trials in Europe and Asia is preferred.

Travel Requirements:

• Ability to travel 25% domestically and international travel

The expected salary range for this position based in California is $190,000 to $240,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. Company is posting role confidentially.