- Interfacing with biologists, chemists, and DMPK scientists to design and conduct preclinical pharmacology studies as part of a project team, incorporating appropriate PK/PD and biomarker assessments as necessary at the appropriate stage of the program to enable development candidate selection and IND preparation, and to inform early clinical development.
- Designing, conducting, and overseeing the execution of in vivo pharmacology and efficacy studies to support the IND (both in-house and at CROs). Providing oversight to a small team of scientists who are involved in conducting these studies.
- Serving as the primary lead for IND enabling pharmacology package and working in collaboration with other project team members.
- Help manage day-to-day operations of pharmacology lab and vivarium.
- Initiating collaborations with external KOLs/ leaders in the field to generate human translational evidence to support the clinical programs.
- Working with internal and external collaborators for indication expansion, collaborating with team members to generate data from preclinical studies to inform subsequent clinical development.
- Authoring appropriate sections of regulatory documents and review documents such as IND, IB, CSRs.
- Providing input into appropriate sections of clinical-protocol design, providing input to clinical development plan, and serving as member of clinical sub-team when needed.
- Developing and providing input into biomarker strategy to enable successful clinical development as a part of the IDP including biomarkers to assess target engagement, pharmacodynamics, disease biomarkers and novel endpoints as appropriate for indication.
- Incorporating metabolic imaging studies (e.g., PET/SPECT, MRI/MRS) into preclinical and clinical programs.
- Ph.D. degree in cancer biology or related field of science.
- At least 8 years of experience supporting discovery/development stage programs in oncology or related areas of science, ideally in biotech/pharma industry or CRO.
- Experience working with cross-functional teams, writing, and authoring scientific and regulatory documents, protocols, reports, and IND filings.
- Experience supporting and engaging with clinical development-stage programs, ability to approach and design projects from a preclinical to clinical translational perspective.
- Demonstrated ability to collaborate with cross-functional colleagues, working with CROs, external collaborators/KOLs required.
- Effective written and oral communications skills.
- Demonstrated ability in taking initiative to develop relationships with internal and external collaborators.
- Ability to collaborate in a multidisciplinary and dynamic environment and experience in mentoring and leading scientific programs.
- Clinical translational orientation, understanding of I/O and drug resistance mechanisms and models, biomarker considerations to enable patient selection/study design, and experience extrapolating relevant information from the preclinical program to the clinical-program design.
- Previous regulatory interaction experience.
- Experience in other diseases areas beyond oncology.
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Preclinical/Translational Pharmacologist - Boston, United States - Kojin Therapeutics
Description
We are seeking a preclinical/translational pharmacologist with experience in developing oncology small-molecule therapeutics. The ideal candidate would have solid experience in designing and conducting preclinical/translational pharmacology studies and be knowledgeable in molecular pathways involved in cell death and survival and experienced in conducting studies to elucidate the mechanisms of action of drug candidates. Prior experience in contributing to INDs and leading IND-enabling preclinical programs is highly desirable. You will conduct research to advance small-molecule therapeutics that work through novel ferroptosis mechanisms, and you will also be able to collaborate and communicate with medicinal chemists, biologists, DMPK and biomarker scientists, and nuclear medicine specialists to enable integration of knowledge across functions to effectively advance our pipeline.
The ideal candidate for this role will have demonstrated success in these responsibilities:
The ideal candidate for this role will have the following qualifications:
Preferred qualifications but not required:
About Us
Kojin Therapeutics, Inc. is harnessing groundbreaking discoveries in cell-state and ferroptosis biology to develop first-in-class, oral treatments for use in patients with various forms of cancer, as well as cardiovascular, immunologic, hepatic, and degenerative diseases. Named after the Japanese deity that tamed fire for the good of humanity, Kojin is located in Boston's Seaport biotech neighborhood. We have developed a drug-discovery platform that integrates computational chemistry, structural biology, chemical biology, target-informed screening, and mechanism-driven pharmacology to develop small-molecule therapeutics that specifically modulate ferroptosis -- a newly discovered form of programmed cell death. Kojin is backed by a strong syndicate of top-tier investors, led by an experienced biotechnology and pharmaceutical-industry leadership team, and driven by creative dedicated professionals.
We accept submission of CVs directly from candidates but not from any third-party recruitment or staffing agencies.
