Company Description
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Position Summary:
The primary role of the Medical Science Manager is to oversee and provide strategic direction for the operational and logistical aspects of Medical Affairs activities including, but not limited to, clinical trials that are intended to support regulatory approval and/or reimbursement of Guardant Health products in Japan, investigator sponsored trials (ISTs), educational programs, and scientific engagements with healthcare providers (HCPs). This role is expected to apply broad Medical Affairs and clinical development experience to manage complex issues, guide effective execution, and support alignment with Japan medical, regulatory, reimbursement, and evidence-generation objectives.
The Medical Science Manager is responsible for developing and managing documents related to the activities owned by Medical Affairs and for driving contract execution. In addition, the Medical Science Manager is expected to provide senior-level oversight of study-related processes, identify operational risks, propose effective solutions, and advise relevant stakeholders on complex matters related to Medical Affairs-led activities. The Medical Science Manager works with Medical Science Liaisons (MSLs) for scientific advisory board meetings, Guardant Health Japan (GHJ)-sponsored seminars, and other Medical-related events acting as operational/logistical support. The Medical Science Manager works cross-functionally with other GHJ departments (such as Regulatory Affairs, Biopharma Business) and assists collaboration with Medical Affairs so that Medical Affairs support will effectively be provided. This role may also lead large Medical Affairs projects or cross-functional initiatives and guide the application of existing processes while contributing to the development of improved ways of working. Essential duties and Responsibilities include, but are not limited to:
· Lead and provide senior-level oversight for the execution of study contracts/agreements between research institutions and GHJ, coordinating external/internal review, identifying potential risks, and advising stakeholders on appropriate resolution of complex issues.
· Develop, manage, and oversee documents including contracts/agreements, invitation letters, and other study-related materials throughout their lifecycle, ensuring quality, consistency, compliance, and timely execution across Medical Affairs activities.
· Contribute senior-level operational and scientific input into protocol development and manage all aspects of study execution (company sponsored research studies) or closely collaborate with academic partners (investigator sponsored collaborative research studies). During study planning, optimize trial design by applying in-depth professional knowledge and judgment to ensure the needs and requirements of all key study stakeholders are met.
· Provide senior-level Medical Affairs support across a broad range of clinical research activities, including study start-up, operational feasibility assessment, site and vendor coordination, study documentation, execution support, issue identification, and process improvement, leveraging in-depth knowledge of clinical research operations, site-level workflows, and applicable compliance requirements.
· Collaborate with MSLs in planning scientific advisory board meetings or other expert engagement activities by providing operational/logistical leadership and execution oversight including communication with vendors, offices of academic conferences, or other third parties, and ensuring appropriate planning, compliant execution, and effective follow-up.
· Liaise with internal stakeholders such as Client Services, Regulatory Affairs, and Biopharma Business to coordinate/facilitate Medical Affairs support for cross-functional activities including, but not limited to, operational/logistical support for clinical trials/IST execution, Medical-related material/document development or review, cross-functional joint meeting.
· Participate in and lead study kick-off meeting in collaboration with other GHJ departments.
· Strategize and oversee information/insight gathering from HCPs, academic societies, health authorities to develop medical strategies for evidence generation, regulatory submission, guidelines, etc.
· Oversee the creation of Purchase Orders, receive, file, and track invoices and facilitate payment to HCPs or other third parties through finance for Medical-related activities. · Support other Medical Affairs activities as needed, including large projects or cross-functional initiatives, and frequently advise internal stakeholders on complex Medical Affairs operational matters.
Qualifications:
Education/Experience Required
· Bachelor’s degree (or higher) or equivalent in science or health-related discipline · 8+ years of relevant clinical development experience in a sponsor (Pharmaceutical or Biotech) or CRO role in a clinical study management role or an equivalent combination of education and experience such as project management or supervisory role.
Technical Skills Required
· Applies good knowledge of the pharmaceutical, diagnostics, or biotech industry.
· Intermediate-to-advanced knowledge of the following computer software programs: Microsoft Office, PowerPoint, Excel, and Word.
· Highly developed written skills, the ability to produce high-quality documents for dissemination both inside and outside the organization.
· Ability to work independently and remotely while maintaining a strong teamwork ethic.
· Multi-dimensional abilities to work on simultaneous tasks, work in high-paced, high-energy environment.
· Ability to work cross-team and at different levels of the organization, whether internal or external relationships to the organization.
· Self-directed, intrinsically motivated, and flexible to changes in an ever-changing dynamic environment.
· Strong problem-solving skills, good attention to detail, time management skills and personal initiative.
· Exceptional human relations skills to lead and coordinate the accomplishment of tasks in collaboration with other people.
· Strict adherence to laws, regulations, relevant national code of practice, and company SOPs.
· Business-level English proficiency in both written and verbal communication.
Work Environment:
· Office-based in shared workspace with a hybrid working arrangement (minimum 3 days per week in the office).
· Approximately 10–20% travel required.
Additional Information
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines. Please visit our career page at: https://www.Guardanthealthamea.com/
AI & Digital Fluency
- Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.
Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.
Please visit our career page at: http://www.guardanthealth.com/jobs/