Senior Scientist, Scientific Affairs

Position Summary We are seeking an execution-focused scientific leader to drive the management of global External Research programs, including Investigator‑Sponsored Research (ISR). This role owns planning, execution, and delivery of multiple concurrent clinical and scientific initiatives in close partnership with leadership, physicians, and cross‑functional teams. The senior scientist will serve as a hands‑on program leader, ensuring timelines, budgets, and quality standards are met while proactively managing risks and operational complexity. The role requires strong scientific fluency in interpreting clinical data, guiding evidence generation, and communicating support for product differentiation and clinical adoption. The ideal candidate thrives in fast‑paced environments, takes initiative, and excels at managing competing priorities while driving programs from concept through completion. Key Responsibilities Scientific Affairs & Physician Engagement Lead development of abstracts, publications, presentations, and scientific materials. Lead or support physician interactions, advisory boards, and working groups to advance study objectives and scientific understanding. Scientific Strategy & Evidence Generation Contribute to and influence the development and execution of the Scientific Affairs and evidence‑generation strategy aligned with organizational and product priorities. Identify evidence gaps and help prioritize clinical, real‑world evidence (RWE), and investigator‑led research initiatives. Cross‑Functional Program Management Lead external research across regions to ensure alignment on clinical and scientific objectives. Track and communicate program status, milestones, and outcomes to senior leadership. Clinical Program Management Serve as lead program manager and primary point of accountability for assigned global clinical studies from initiation through close‑out. Develop and maintain integrated project plans, timelines, budgets, and resourcing strategies. Ensure study outputs are actionable and aligned with downstream publication, regulatory, and commercialization needs. Ensure compliance with ICH‑GCP, FDA, EU MDR, and applicable global regulatory standards. Support inspection and audit readiness (FDA, notified bodies, internal audits). Vendor, Site & Financial Oversight Oversee study budgets, tracking, and financial performance. Provide input into contracts, payments, and site engagement strategies. Team & Leadership Contributions Mentor junior team members and contribute to a high‑performing, collaborative culture. Drive accountability, ownership, and a bias toward action across teams. Qualifications Experience 12+ years (Bachelor’s), 8+ years (Master’s), or 5+ years (PhD) in MedTech, Biotech, Pharma, or related industry. Demonstrated success leading global clinical programs and external research initiatives. Core Capabilities Ability to distill and communicate complex clinical data to diverse stakeholders. Strong expertise in clinical study execution and regulatory frameworks (ICH‑GCP required). Experience working with KOLs, investigators, and advisory boards. Proven ability to manage cross‑functional programs and external partners (CROs/vendors). Scientific writing, data interpretation, and publication experience. Working knowledge of statistics required. Leadership & Execution Skills Excellent communication, influencing, and stakeholder management skills. Strong problem‑solving ability in fast‑paced, ambiguous environments. Highly organized, proactive, and results‑oriented. Other Therapeutic area experience (e.g., hypertension, cardiology, vascular physiology). Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook). Salary range: $166,954 - $181,000 (Commensurate with experience, skills, education and training). The successful candidate's starting base pay will be determined based on job‑related skills, experience, qualifications, work location and market conditions. Equal Employment Opportunity At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Pre‑Employment Requirement Employment for all field‑based roles is contingent upon successfully completing a pre‑employment background check and/or drug screen. Radiation Safety Requirement Employees in roles that involve radiation sources (e.g., x‑ray equipment) will be issued a personal dosimetry badge to monitor occupational exposure and are required to wear it in accordance with company policy and applicable regulatory standards. Protective equipment and training will be provided as needed. #J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd