Harbinger : Senior Clinical Research Scientist

Senior Clinical Research Scientist

Who We Are

Harbinger Health, a Flagship-founded company, is pioneering early cancer detection. Harbinger aims to detect cancer, at the earliest stages, to save lives. Our platform leverages proprietary biological insights and artificial intelligence to enable high-resolution, molecular views on cancer from blood. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.

Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics (Nasdaq: FHTX), Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics (Nasdaq: SGTX).

Position Summary

The Senior Clinical Research Scientist will have shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of early Harbinger Health sponsored clinical program strategies, and possibly some Investigator-Initiated Trials. As such, the Clinical Scientist will provide scientific input into design & implementation of clinical trials, their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to IND/NDA/BLA). The Clinical Scientist may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience.

This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to Harbinger Health. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice (GCP) and regulatory requirements. 

Key responsibilities

• Works cross functionally to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents.
• Provides clinical/scientific input into design & implementation of clinical trials, their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to IND/NDA/BLA).
• Establishes key relationships internally with clinical project teams, and externally with investigators/KOLs, regulatory bodies and external service providers.
• Is accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its approval.
• Leads the development of the protocol and related documents and the development and delivery of the clinical study report to meet GCP, ICH and all Harbinger Health quality standards.
• Leads cross functional projects to ensure the successful passage of products through all phases of the medical device development processes or contributes to one or more elements of such a project as a technical expert.
• Reviews and interprets medical data and clinical trial data and draws conclusions with Chief Medical Officer.
• Supports the development of clinical components of regulatory and EC/IRB submission documents. Prepares and provides input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, regulatory responses).
• Participates or leads as needed the review and assessment of new opportunities fo