- Work closely with the preclinical group to define translational hypotheses, including potential pharmacodynamic and predictive biomarkers.
- Design and implement bioanalytical clinical biomarkers and exploratory translational strategies; adhere to clinical and regulatory submission protocols.
- Conduct experiments to design and troubleshoot clinical assay design or ideas in the lab or manage direct report/CRO to find answers.
- Successfully manage CROs and establish relationships to develop biomarker assays, monitor assay qualification/validation at CROs, as well as bioanalytical/biomarker testing in the clinical trials.
- Collaborate with clinical operations and the central lab to develop appropriate clinical laboratory manuals and to support sample management and logistics.
- Perform integrative analysis of multiple biomarker assessments including gene expression, IHC/Multiplex IF data, safety biomarker, and drug response data for baseline and post-dose biomarker discovery for clinical programs.
- Contribute to quality and timely submission of all clinical biomarker-related documents and materials for regulatory filings, including scientific advice filings, INDs, meeting briefing books, and other requests from global regulatory authorities.
- Humanity - We genuinely care about patients and about one another.
- Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
- Creativity - We are creative problem solvers.
- Collaboration - We are more than the sum of our parts.
- Curiosity - We have a growth mindset and push conventional thought and theory.
- Ph.
- Deep understanding of the pre-clinical, translational, and clinical stages of drug development.
- Extensive working knowledge of biomarker and bioanalytical assay development and cutting-edge Omics methodologies in the clinic.
- Experience leading within and collaborating effectively as a member of a cross-functional team.
- Demonstrable knowledge of appropriate quality standards including ICH/GCP, guidance, and global regulations.
- Experience in selection and management of external CROs.
- Excellent analytical skills, with an ability to communicate complex issues in a simple way.
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Senior Scientist, Clinical Biomarkers - Boston, United States - Entrada Therapeutics Inc.
Description
The Organization
What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.
Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index.
Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immune mediated diseases, among others.
Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable.
We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.
You are a versatile, self-motivated team player who looks forward to rolling up your sleeves. You work collaboratively with different teams and CROs to support preclinical and clinical biomarker development activities. You enjoy a fast-paced environment and are capable of juggling competing priorities. You follow up and follow through, connecting problems with solutions efficiently. You have strong interpersonal skills that allow you to effectively build working relationships inside and outside of the company.
The Opportunity
As a Biomarker development leader, you will join the Biomarkers Team to spearhead and support projects through early to late clinical development.
You will focus on projects from the start of assay development to clinical trial implementation as well as data management to ensure we are obtaining high-quality data from our clinical trials.
ResponsibilitiesAt Entrada, our passion for science, our devotion to patients and our values drives our behavior:
in biological sciences and 5 or more years of industry (biotech/pharmaceutical) clinical biomarker experience, or MS with 7+ years, or BS with 10+ years of experience.
By becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance.
Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.
Entrada Therapeutics is an equal opportunity employer.Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
Third Party Staffing AgenciesEntrada does not accept unsolicited resumes from any source other than directly from candidates.
For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.
Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.
Privacy StatementEntrada Therapeutics, Inc.
(the "Entrada," "we," "us," or "our") respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information.
Please reference our privacy statement here to understand how and when your data is being used.
