Principal Scientist, Oncology Translational Science and Clinical Biomarkers
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck’s Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At Merck, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
The Principal Scientist acts as a leader in translational research and biomarker development for Merck’s Oncology programs. Working with early- and late-stage clinical development teams, the Principal Scientist will have the opportunity to guide translational research and clinical biomarker development across a portfolio of early- and late-stage oncology clinical programs.
This New Jersey or Pennsylvania-based position will report into the Director of Oncology Translational Science and Clinical Biomarkers. The individual will assume a role in a dynamic, cross-functional environment as the key interface between early-and late-stage development teams and functional areas with expertise in various scientific and operational aspects of translational research and biomarker development. The Principal Scientist will be responsible for bi-directional communication, ensuring that emerging translational data from individual clinical programs are interpreted and communicated for maximal impact throughout the organization, while also ensuring that team-level clinical strategy and clinical study design are guided by emerging cross-programmatic translational data.
Key responsibilities include, but are not limited to the following:
- Supports individual early- and late-stage product development teams as a key individual responsible for a portfolio of sponsored and partnered translational research and early biomarker development.
- Collaborates with the development team lead and the companion diagnostics lead, develops a formal, integrated team-level strategy for translational research, exploratory biomarker and diagnostic development.
- Collaborates with clinical leads, develops protocol-level biomarker plans for each clinical study, and ensure efficient execution.
- Interfaces and collaborates internally and externally with biologists, geneticists, physicians, pathologists, and bioinformatics experts to develop a scientifically and strategically robust portfolio of research that will answer critical questions about mechanisms of immunotherapy response and resistance.
- Ensures that team-level strategy is aligned with the broader cross-programmatic strategy.
- Uses emerging translational datasets from across the oncology organization and from the external environment to inform clinical study design as appropriate.
Specific responsibilities include, but are not limited to the following:
- Collaborates with Product Development Team and Early Development Team leads,
- Develops overall translational science and biomarker strategy, and present periodic updates to senior oncology leadership.
- With the companion diagnostic lead, runs a regularly scheduled biomarker meeting for each development team’s clinical subteam.
- Sets protocol-level translational science and biomarker strategy.
- Incorporates biomarker assessment from tumor, peripheral blood and other compartments into each protocol, including pharmacokinetic, target engagement, and pharmacodynamic assays as appropriate.
- Collaborates with clinical and companion diagnostic leads, author protocol-specific biomarker plans and ensure their efficient operationalization.
- Collaborates with each Clinical Trial Team to ensure proper incorporation and execution of translational science and biomarker plans into protocols, informed consent forms and procedure manuals.
- In conjunction with team statisticians, presents and interprets routine biomarker data.
- For higher-dimensionality datasets (e.g. next-generation sequencing), develops formal statistical analysis plans, analysis reports and data communication plans.
- Participates in routine educational meetings and review forums with the broader team of oncology biomarker development scientists.
- Communicates emerging translational data from elsewhere in the oncology organization (e.g. from other products, indications or pan-tumor analyses) back to individual development teams to inform team-level strategy.
- Works with computational biology and informatics colleagues, develops custom data visualizations to support team development needs (e.g. novel biomarkers, other aspects of clinical development strategy).
- Drives reverse translation of clinical findings.
- Interfaces with translational and discovery laboratories to drive implementation of preclinical/translational projects based on emerging clinical/translational datasets.
- Builds and supports external partnerships.
- Interacts with external investigators around development of new translational research proposals.
- Interacts with external investigators around the execution of key approved investigator-sponsored studies..
- Authors and supervises the execution of biomarker and translational resaerch substudies in Merck-sponsored clinical studies.
- Attends conferences and takes advantage of additional internal/external resources to stay current on relevant translational science.
- Drives translational publication strategy as a member of publication teams.
- M.D or M.D./Ph.D with a minimum of 5 years' experience in oncology biomarker development and/or translational and early stage clinical research
- Ph.D. with a minimum of 5 years of direct industry experience withbiomarker development
Must have experience in clinical trial development andexecution
Stronginterpersonal skills, as well as the ability to function in a team environmentare essential
Aproven track record in clinical medicine and background in biomedical researchis essential;
Demonstratedrecord of scientific scholarship and achievement;
- Ability to demonstrate a broad understanding of the end-to-end drug and diagnostic development process, and specific expertise in oncology and/or immunology
- Possess a range of knowledge and expertise that spans preclinical and translational research in oncology and/or immunology, early biomarker development, clinical application of biomarkers and diagnostics, and clinical trials
- Possess leadership and communication skills to regularly interface with a wide variety of stakeholders within the organization, as well as with external clinicians and scientists
- Board Certified or Eligible in Oncology
- Prior experience in related areas with expertise in preclinical, translational and/or early-stage clinical research in oncology
- Specific expertise in immunology and/or immuno-oncology
- Project experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development is desired. In particular, must have the ability to apply a strategic mindset to the generation and interpretation of exploratory biomarker data, with an understanding of how such data can be used to accelerate preclinical and clinical drug development
- Proven mastery of both technical and bioinformatic aspects of translational research and biomarker development. Facility with the generation and interpretation of high-dimensionality datasets
- Experience in cross-functional, highly matrixed collaborative groups
- Excellent communication skills that can cross technical areas
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Clinical Research (M.D.)
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck