- Study Design and Execution: Lead the design, planning, and execution of translational studies in indication-relevant animal models and primary human cellular and tissue systems to identify and validate biomarkers and explore drug candidate mechanism of action. Collaborate with cross-functional teams to ensure alignment with discovery and development goals as well as regulatory requirements.
- Further Exploration of BESREMi: Collaborate with clinical development team to further explore the potential of BESREMi in MPN and other areas of Oncology. Conduct translational studies internally and be involved in investigator-initiated trials (IITs) or company sponsored clinical trials to maximize the clinical potential of BESREMi.
- Data Analysis and Interpretation: Oversee the analysis, interpretation, and reporting of in vitro and in vivo pharmacology/translational biomarker data, including pharmacokinetic and pharmacodynamic parameters, exposure-response relationships, and safety/tolerability profiles. Provide scientific insights to inform decision-making and optimize study outcomes.
- Drug Development Strategy: Contribute to the development and implementation of clinical pharmacology strategies to support the progression of investigational drugs through all phases of clinical development. Generate scientific rationale for dose selection, formulation optimization, and therapeutic target validation.
- Regulatory Interaction: Work with regulatory affairs to support the preparation and review of regulatory submissions, including investigational new drug (IND) applications, new drug applications (NDAs), and marketing authorization applications (MAAs). Address inquiries and provide scientific justifications for study designs, endpoints, and data analyses.
- Scientific Leadership: Serve as a subject matter expert in translational biomarkers, target biology and candidate therapeutic mechanism of action, providing guidance and mentorship to junior scientists, clinicians, and project teams. Contribute to the scientific literature through publications, presentations, and participation in professional conferences and working groups.
- Cross-Functional Collaboration: Collaborate closely with colleagues in data sciences, biologics, immunology/pharmacology, clinical development, and regulatory affairs to integrate translational biomarker and mechanism of action insights into overall drug development strategies. Foster a culture of scientific excellence, innovation, and collaboration.
- Ph.D. in oncology, immunology, immuno-oncology, pharmacology, pharmaceutical sciences, or a related discipline.
- 3+ (for senior scientist) or 8+ (for principal scientist) years' experience in the pharmaceutical or biotechnology industries, including a proven track record of leadership and scientific achievement in translational sciences.
- Expertise in in vivo model design and biomarker discovery, both internally and via contract research organizations and academic collaborations.
- Experience with primary human cellular/tissue-based assays to guide/inform indication selection, biomarker discovery and mechanism of action.
- Experience with immuno-oncology and autoimmune disease/chronic inflammation targets and associated in vitro and in vivo models is preferred.
- Experience in clinical trial design and/or clinical operations in either company-sponsored, or IIT clinical trials is strongly desirable.
- Strong analytical skills, with proficiency in pharmacokinetic/pharmacodynamic software (e.g., NONMEM, Phoenix WinNonlin, R) is preferred.
- Experience working closely with academic collaborators via sponsored research agreements or IITs is preferred.
- Excellent communication and presentation skills, with the ability to effectively convey complex scientific concepts to diverse audiences.
- Demonstrated leadership capabilities, including the ability to mentor and develop talent, foster teamwork, and drive results in a dynamic environment.
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Senior/Principal Scientist, Translational Sciences - Bedford, United States - PharmaEssentia U.S.A.
Description
Senior/Principal Scientist, Translational SciencesJob summary:
PharmaEssentia Innovation Research Center (PIRC) is seeking a highly motivated and experienced senior or principal scientist to join our Translational Sciences team and contribute to the development of first-in-class and best-in-class biotherapeutics, including cytokines, antibodies, and antibody-drug-conjugates. The successful candidate will contribute to the design, execution, and interpretation of translational biomarker and mechanism of action (MOA) studies to support the development and regulatory approval of novel therapeutics as they transition from late discovery into first in human clinical trials and beyond. In this position, you will utilize your expertise in pharmacokinetics, pharmacodynamics, and biomarker discovery to guide drug development and biomarker strategies, optimize dosing regimens, and ensure the safety and efficacy of investigational drugs. You will also contribute to translational activities aimed at maximizing the potential of BESREMI, PharmaEssentia's marketed drug for the treatment of myeloproliferative neoplasms. These efforts include indication expansion, novel combinations, and refining/improving biomarker approaches to guide dosing and patient selection. Additionally, you will provide scientific leadership, mentorship, and cross-functional collaboration within the Translational Sciences team and across other departments.
The Company:
It's not often that you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You'll find that rare opportunity at PharmaEssentia. Join us, and let's transform lives, together.
PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology, oncology and immunology, with one approved product and a diversifying pipeline. We believe in the potential to improve both the health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.
Founded in 2003 by a team of Taiwanese American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (TPEx: 6446) and are expanding our global presence with operations in the U.S., Japan, China and Korea, along with a world-class biologics production facility in Taichung.
Our new research center, PharmaEssentia Innovation Research Center (PIRC), will build upon our invention and discovery-based innovation efforts originally established in Taiwan that led to a transformative advancement for treating polycythemia vera (one of the myeloid proliferative neoplasms). At PIRC, we aim to expand our current expertise in related therapeutic areas and identify novel therapeutic approaches in early to mid-stage discovery and development. Data scientists will leverage artificial intelligence and machine learning to inform new target and indication selection. The company is also recruiting for talented scientists who have deep knowledge in immunology, translational science, bioinformatics and biologics platforms to develop novel drugs leveraging disease-driving biology, novel technology in protein engineering, antibody discovery and new modalities.
Summary of Key Responsibilities:
As a Senior/Principal Scientist in Translational Sciences, you will play a pivotal role in advancing the understanding of drug pharmacology and contributing to the development of innovative therapeutics to address unmet medical needs. Your scientific expertise, leadership skills, and collaborative approach will be critical for driving drug development programs forward and ultimately improving patient outcomes at PIRC.
At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.
