Senior Director/Executive Director, Clinical Operations
4 weeks ago
Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its AlluminoxTM technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.
Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients.
Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives.
Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland, and India.
The Senior Director/Executive Director of Clinical Operations will be a key leader with responsibilities to manage all clinical operations in coordination with other leadership at the company.
This is an excellent opportunity to join a rapidly growing company that is well-funded to advance novel cutting-edge anticancer therapies into registration trials and later commercialization.
The candidate will function as the product Global Study 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 Senior Director/Executive Director will be a roll-up of the sleeves to get the job done team member, work with a sense of urgency, with attention to details, and work with utmost integrity in a fast-paced small biotech environment.
The ideal candidate will have at least 10 years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in oncology drug development.
The candidate will have strong leadership skills with the ability to be hands-on and drive execution and manage the clinical team.
Align with the SVP of Clinical Development for successful implementation of studies. Responsible for management of compounds at the program and franchise levels including supporting at the Portfolio Design Committee.
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.
Coordinate activities with other functional groups, such as Regulatory, Drug Safety, Biostatistics, Supply Chain, etc.
Lead the team developing critical study documents, including, but not limited to study protocols, informed consent form templates, various management plans, and study trackers.
Lead global timelines and budget management to optimize achievement of study goals and milestones.
Provides leadership, effective management, and guidance to the Clinical Operations group.
Develops and continually improves departmental infrastructure, including development of SOPs, work practices, training, and workshops, and ensuring inspection-ready state of clinical operations activities.
Ensures that clinical trials are properly resourced, managed, and executed within budget and in accordance with established timelines.
Ensures clinical trials are conducted in compliance with relevant SOPs, regulatory requirements, Good Clinical Practice, and the highest quality standards.
Evaluates data quality and study progress on an ongoing basis, informs management of potential issues, and works with the team on corrective action plans.
Oversees the selection and management of CROs, clinical consultants, and vendors and may serve on the Governance and Oversight Committees.
Ensures appropriate maintenance of clinical trial master files and documents.
Responsible for representing Clinical Operations on cross-functional project teams for strategic planning, risk/benefit assessments, and achievement of company, project, and team goals.
Provides leadership for Clinical Operations-related issues and advises management team of potential issues and solutions.
Manages, mentors, and develops staff in order to maximize their capabilities and contributions to the organization.
Must be able to travel up to 20% of time on average, may be higher in accordance with company and/or program requirements.
BS degree or higher in science, health, or related field (MS degree preferred).
Minimum 12 years relevant industry experience in clinical/medical research or pharmaceuticals/medical devices.
Minimum 10 years relevant experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.
Experience in CRO selection and management, including drafting requests for proposals (RFPs), bidding process, vendor negotiations, etc.
Excellent computer skills.
Travel Requirements:
~ Ability to travel 25% domestically and international travel.
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans, and more for full-time employees.
We recommend anyone coming onsite to be vaccinated for COVID-19.
Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.
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