Job description

Invivoscribe is an industry pioneer in oncology diagnostics, dedicated to improving the standard of global healthcare for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used in over 160 countries. Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials. Our harmonized clinical laboratories offer a menu focused on clinically significant biomarkers which support therapeutic decisions, minimal residual disease (MRD) monitoring, patient stratification, trial enrollment, and the development of companion diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we’re just getting started!

We are looking to add a General Manager to our clinical lab and regulatory teams in Japan. The General Manager effectively manages the day-to-day operations of LabPMM GK including the clinical laboratory and ensures that the testing performed is under the implemented quality management system. S/he may manage all aspects of operations in Japan, clinical development, data collection and compliance with applicable regulations and be responsible for oversight of adverse event reporting, safety responsibilities, monitoring, adherence to protocols. The General Manager will be listed as the GMCO (SOUKATSU) in support of the Marketing Business License and as Selling Manager in support of the IVD Selling License. Core Responsibilities Include:
General Manager:

• Manage/Lead country specific operations and cross functional teams comprised of sales, clinical and administrative staff. Motivate and mentor employees to ensure high performance and take corrective actions as appropriate.
• Recruit, grow, mentor and operate the regional teams to achieve revenue & business objectives.
• Initiate and drive country specific projects, establish frameworks to evaluate the results and proactively take necessary actions. Participate in development projects. Organize, write and maintain standard documentation and compile project specific reports.
• Support global initiatives of the company as appropriate by collaborating with counterparts at HQ and at other international subsidiaries to include Accounting, Human Resources, Legal, Facilities, QA, Regulatory, and other.
• Serves as the approver of internet bank transfers to include payroll transfers.
• Prepare budget and monitor all expenses associated with Japan operations.
• Participate in strategic planning specific to expansion of business in Japan/Asia.
• Implement the directives and task assigned by senior management.
• Ensure compliance to relevant laws, regulations, and standards.
• Ensure a safe and efficient working environment.

Laboratory Operations:

• Effectively manages the day to day activities of administrative and laboratory staff. Provides technical guidance, training and development. Ensures the timely completion of administrative tasks such as timekeeping, scheduling, training requirements and performance appraisals. Responsible for hiring, managing performance and corrective measures.
• Meets with corporate customers, especially pharma, that would likely engage Invivoscribe’s test and companion diagnostic services including conducting market research to pinpoint pharma companies that are most likely to need and use our products and services.
• Facilitates, establishes and grows relationships with above mentioned companies leading to opportunities to introduce Invivoscribe and bid on services.
• Maintain intramural relationships with important persons in the field of molecular diagnostics and precision medicine.
• Meet with clients and physician users.
• Generate and evaluate marketing materials.
• Research and evaluate new clinical assays.

Qualifications:

• B.S. in biological science, pharmaceutical science, medical science and 10+ years applicable work experience to include 5+ years management experience. Advanced degree preferred. Equivalent combination of academics and experience will be considered. Experience should include:
• Licensed Pharmacist highly beneficial to comply with GMCO and Selling Manager roles.

• In-depth knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Japanese clinical regulations.
• Proficient English written and verbal skills; basic proficiency, conversational.
• Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs.
• Evidence of Covid-19 vaccination

Job Type: Full-time

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