Director/Senior Medical Sciences (Medical Monitoring) at Adaptive Biotechnologies

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Gene Therapy, OphthalmologyIndustries

Requirements

MD or equivalent required with Board Certification in Ophthalmology (preferred) or subspecialty and a current California medical license
Minimum of 5-7 years direct experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a pharmaceutical, clinical trial environment or CRO required
Proficient with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as medical terminology, clinical trials, and clinical research

Responsibilities

Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial
Review and analyze the eligibility of participants per inclusion/exclusion requirements of a clinical trial
Review all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting
Provide review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
Ensure activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations
Consult with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments
Develop and/or review operational, medical monitoring, and safety plans for studies
Lead and/or participate in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies
Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete
Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events
Provide input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training

Skills

Clinical Trials

Medical Monitoring

Safety Management

Adverse Events

SAE Review

Protocol Design

Study Documents

Risk Assessment

Investigator Training

Gene Therapy

Adaptive Biotechnologies

Decodes immune cell genetic information for diagnostics

About Adaptive Biotechnologies

Adaptive Biotechnologies focuses on using the immune system to improve disease diagnosis and treatment. The company decodes genetic information from immune cell receptors, which are essential for the immune system's ability to identify and respond to diseases. One of their key projects is the ImmuneRACE study, which analyzes blood samples and swabs from participants to understand the immune response to COVID-19. This research aims to enhance diagnostics, treatments, and vaccines for the virus. Adaptive Biotechnologies uses advanced data algorithms to analyze immune cell genetics and generates revenue through partnerships with pharmaceutical companies, licensing technology, and offering diagnostic services. Their goal is to leverage immune system data to advance healthcare and develop effective therapies for various diseases.

Seattle, WashingtonHeadquarters

2009Year Founded

$395.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Company Equity

Performance Bonus

Risks

Competition from startups like Adaptive could divert focus from core biotechnology efforts.

Regulatory hurdles may delay EndoSound partnership's endoscopy device development.

BeiGene collaboration success depends on the progress of their pipeline treatments.

Differentiation

Adaptive Biotechnologies leverages immune system data for advanced diagnostics and treatments.

Their clonoSEQ® assay is FDA-authorized for minimal residual disease detection in blood cancers.

The ImmuneRACE study enhances understanding of immune responses to COVID-19.

Upsides

Collaboration with BeiGene expands market reach for clonoSEQ® in lymphoid malignancies.

EndoSound partnership highlights potential in innovative gastroenterology diagnostics.

Strong corporate culture recognized at GeekWire Awards attracts top talent.

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