Clinical Director at Abbott Laboratories Limited

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

08 Sep, 26

Salary

0.0

Posted On

10 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Study Design, Project Management, Clinical Trial Execution, Budget Management, Regulatory Compliance, Staff Supervision, Contract Negotiation, Protocol Review, Risk Management, Cross-functional Leadership, Clinical Strategy Development, Vendor Management

Industry

Hospitals and Health Care

Description

JOB DESCRIPTION: Primary Function Provides global or regional leadership for a particular regional or global clinical program. Ensures design and execution of high quality clinical studies to ensure safety and effectiveness of the company’s products. Manages clinical project team members to appropriate and timely completion of projects; oversees project timeline development and maintenance. Internally interfaces with data management and biostatistics, clinical research associates, medical directors, functional management, and acts as a company liaison with investigators and clinical site staff. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Major Responsibilities Responsible and accountable for several concurrent clinical studies for multiple programs and therapeutic areas. Leverages resources, expertise, and knowledge across projects to ensure deliverable attainment. Develops staffing plans to appropriate align resources to workloads. Hires, trains, develop, mentors, and supervise managers and clinical staff. Develops staffing plans. Participates in and assists in the development of global clinical strategies for assigned therapeutic area(s) working in collaboration with regulatory affairs, marketing, research & development, reimbursement and outcomes planning, and regions to obtain approvals by the most effective method possible. Supports regulatory/clinical strategies as the clinical representative for the therapeutic area or region. Oversees the preparation and management of budgets for projects in therapeutic area. Negotiates contracts and budgets with sites and vendors. Reviews and approves protocols for projects; reviews final study conduct documents such as study manuals, study tools, etc. Drafts, reviews, and approves instructions for use for investigational devices. Attends investigator and coordinator meetings, representing the region. Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed. Provides advice on the reportability of adverse events and other clinical trial issues to regulatory agencies. Determines membership criteria and identifies potential members for clinical events committees and data monitoring committees. Reviews and approves trigger plans for Clinical Event Committee and Data Monitoring Committee. Manages data release and review meetings for projects in therapeutic area; reviews and participates in finalizing and approving final manuscript or final reports for projects. Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate. Reviews and approves corrective action plans at individual sites and across study. May participate in internal/external study-related audits. Develops and maintains Clinical Affairs infrastructure such as the drafting and/or reviewing of Divisional Work Instructions and local Instructions. Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable company’s SOPs and policies. Minimum Requirements Education: Bachelor’s degree or equivalent Background: 10+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials。 Preferred Requirement 5+ years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. PhD-level degree (or equivalent), or qualification in medicine preferred. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Clinical Affairs / Statistics DIVISION: MD Medical Devices LOCATION: Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Not Applicable Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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Responsibilities

Provides global or regional leadership for clinical programs, ensuring the high-quality design and execution of studies to verify product safety and effectiveness. Manages project teams, budgets, and regulatory strategies while interfacing with internal stakeholders and external investigators.