Medical Director, Clinical Development #4003 (California Based) at GRAIL Inc
Raleigh, NC
About the Job
Our mission is to detect cancer early, when it can be cured. We 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.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com.
The Medical Director in Clinical Development is responsible for providing clinical expertise to support the design, conduct, and analysis of clinical and real-world evidence studies in support of GRAIL’s product pipeline as well as commercial launch and post-marketing commitments. This role will interact with cross-functional teams, including colleagues from Clinical Operations, Biostatistics, Clinical Data Management, Medical Affairs, Regulatory Affairs, Research and others.
Responsibilities:
Preferred Qualifications:
The expected, full-time, annual base pay scale for this position is $252,000 - 336,000 Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com.
The Medical Director in Clinical Development is responsible for providing clinical expertise to support the design, conduct, and analysis of clinical and real-world evidence studies in support of GRAIL’s product pipeline as well as commercial launch and post-marketing commitments. This role will interact with cross-functional teams, including colleagues from Clinical Operations, Biostatistics, Clinical Data Management, Medical Affairs, Regulatory Affairs, Research and others.
Responsibilities:
- Act as a medical monitor for designated clinical and/or real-world evidence studies, serving as a member of the cross-functional clinical study management team
- Issue queries and communicate with clinical study site staff to ensure completeness and accuracy of clinical data
- Prepare and review answers to safety queries from regulatory authorities and IRBs as needed
- Collaborate with other medical directors, clinical scientists, clinical data managers, biostatisticians, data scientists, and other functional stakeholders on the design, conduct, and analysis of clinical studies
- Collaborate with colleagues from biostatistics to develop statistical analysis plans and serve as a co-author on clinical study reports and other study deliverables
- Contribute to the development and preparation of regulatory documents
- Provide scientific and medical support for publications and presentations to ensure scientific and medical accuracy and cross-functional alignment
- Support efforts to advance clinical development and scientific research plans (review and interpretation of study data; engagement of key opinion leaders; providing strategic and scientific input to study-level and program-level teams)
- Develop formal networks with external investigators and thought leaders to support clinical study programs
- Ensure compliance with industry regulations, policies, guidelines and standards
Preferred Qualifications:
- MD required, board certified/board eligible in oncology strongly preferred
- 2 + years of clinical practice experience
- 3 + years of experience in a diagnostics or pharmaceutical clinical development setting
- Experience in designing and conducting clinical studies, particularly registrational and/or clinical utility studies for reimbursement
- Prior experience in a medical monitoring role strongly preferred, including medical case review and assessment of adverse event reports to determine seriousness and reportability
- Experience in oncology, genomics, diagnostics, cell-free DNA-based applications, or similar applied medical fields is strongly preferred
- Familiarity with the development of real-world evidence from real-world data (e.g., healthcare claims or electronic health records)
- Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA, ISO) and a commitment to compliance
- Experience authoring Standard Operating Procedures (SOPs) and similar documents in support of the role and responsibilities of a Medical Director
- Excellent verbal and written communication skills, including clear and confident presentation skills
- Ability to network and partner within external investigator and national organizations
- Results oriented and strong attention to detail
- Strong leadership and collaboration skills
The expected, full-time, annual base pay scale for this position is $252,000 - 336,000 Actual base pay will consider skills, experience, and location.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.