Full-Time

Senior Director

GRAIL

GRAIL

1,001-5,000 employees

Designs cancer screening tests

Data & Analytics

$270,000 - $360,000

Bonus, Long-term incentive plan

Senior, Expert

Menlo Park, CA, USA

Required Skills
Communications
Marketing
Requirements
  • MD required
  • 15+ years substantial experience in Medical Device, IVD, or Biotech/Pharma Industry experience
  • 5+ years medical/clinical safety and vigilance
  • Knowledge of US FDA, MHRA, European, and other global regulations
  • Strong leadership capabilities
  • Significant skills and experience in post-marketing safety assessment
  • Demonstrated in-depth knowledge of principles of clinical trial methodology and design
  • Proven track record in dealing with difficult safety issues
  • Ability to influence, negotiate, and communicate with internal and external customers
  • Excellent verbal and written communication skills
  • Knowledge of Good Clinical Practices (GCP)
  • Collaborate and influence with cross-functional teams without direct oversight
  • Required critical thinking
  • Self-motivated
  • Strong communication and presentation skills
Responsibilities
  • Monitoring, signal detection, analysis, interpretation, and documentation of medical safety information
  • Ensure timely and appropriate global reporting of clinical and commercial products
  • Develop a comprehensive safety strategy and vision
  • Support writing, review, and submission of ad hoc reports, narratives, IFU, annual/quarterly reports, CER, PMCF, PSUR, etc.
  • Serve as the external 'face' of the GRAIL in interactions with investigators, regulatory authorities, contract research organizations (CRO) and development partners on safety related issues
  • Manage Health Hazard Assessments, and provide safety guidance to internal and external teams
  • Leads and oversees ongoing safety risk-benefit assessments and provide support to Quality and Regulatory Affairs organizations
  • Partner closely and effectively with Clinical, Medical Affairs, Regulatory, Quality, and Laboratory Operations leaders to proactively assess, respond and communicate safety concerns for products throughout the lifecycle
  • Provide oversight, medical expertise, and leadership for end-to-end medical safety strategy
  • Provide input, assess the significance of relevant information, and generate, author, and/or review medical safety reports as required by worldwide regulatory agencies
  • Connect with respective colleagues in the Clinical, Medical Affairs, Global Regulatory Affairs, and Quality for the implementation and compliance of post-marketing risk management commitments
  • Develop a robust safety assessment and position for GRAIL
  • Present and communicate Safety discussions of MCED tests to internal and external stakeholders

GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

Company Stage

M&A

Total Funding

$11B

Headquarters

Menlo Park, California

Founded

2016

Growth & Insights
Headcount

6 month growth

5%

1 year growth

13%

2 year growth

26%

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.