Otsuka Pharmaceutical Companies (U.S.) · 4 months ago
Director, Global Clinical Operations
Palo Alto
Full-time
Onsite
Director/Executive
$228K/yr - $250K/yr
10+ years expRecor Medical is pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension. The Director of Global Clinical Operations will establish strategic clinical plans, lead the Clinical Affairs department, and ensure operational effectiveness of clinical studies supporting the Paradise™ uRDN System.
Health CareMedical
Responsibilities
Participate with senior management to establish strategic clinical plans and objectives aligned with corporate goals
Initiate proposed decisions on clinical trial implementation and ensure operational effectiveness across global studies
Support the implementation of key business segment strategy into functional clinical plans and guide execution across regions
Contribute to development of organizational clinical policies that support regulatory submissions and commercial objectives
Ensure clinical budgets and schedules meet corporate requirements and optimize resource utilization
Lead the Clinical Affairs department by providing directions to managers and team leaders who oversee daily operations and staff
Lead team(s) to develop new clinical methods and solve complex clinical trial challenges
Oversee planning, execution, and completion of clinical trials from protocol development through final clinical study report
Establish and implement standardized clinical processes and tools to enhance operational efficiency
Manage clinical budget planning, forecasting, and resource allocation to optimize program performance
Interact with senior management, executives, and major clinical stakeholders which frequently involves negotiating matters of significance
Reconcile multiple stakeholder views to drive clinical study results and organizational objectives
Collaborate with Regulatory and Quality Affairs, Medical Affairs, and Scientific Affairs to ensure integrated approaches
Partner with Research & Development and new business development to align clinical evidence generation with product development activities
Support Marketing and Commercial teams with clinical evidence communication strategies
Develop creative solutions when faced with new challenges where there aren't clear precedents or guidelines to follow
Participate in corporate development of methods and techniques for clinical evidence generation
Engage with key opinion leaders and clinical investigators to foster strong research partnerships
Represent Recor Medical in interactions with regulatory authorities and at scientific conferences
Guide development of high-impact clinical publications and presentations
Qualification
Required
Minimum of Bachelor's degree in life sciences or related field required; advanced degree (Master's or above) preferred
Minimum of 10+ years of clinical affairs experience in the medical device, biotech, or pharmaceutical field, with at least 5 years in a leadership role
Proven track record of successfully leading global clinical trials from conception through completion
Comprehensive understanding of global regulatory requirements (FDA, BSI, etc.) and clinical evidence standards
Strong knowledge of clinical research methodologies, biostatistics, and GCP/ISO 14155 standards
Excellent leadership abilities with demonstrated success in building and developing high-performing teams
Strategic thinker with the ability to translate business objectives into actionable clinical plans
Outstanding communication skills with the ability to effectively negotiate matters of significance
Experience with global clinical operations, site management, and clinical data management
Preferred
Advanced degree (Master's or above)
Experience with cardiovascular medical devices; hypertension and/or renal denervation experience preferred
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
Recent News
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