Latigo Biotherapeutics, Inc.
Director/ Sr. Director, Clinical Pharmacology
Latigo Biotherapeutics, Inc., Thousand Oaks, California, United States, 91362
Director/ Sr. Director, Clinical Pharmacology
3 days ago Be among the first 25 applicants Position Description
Reporting to the VP of Translational Science, the Director/Sr. Director, Clinical Pharmacology will work in our early development teams on small molecule programs, with responsibility for the Clinical Pharmacology package, connecting the project from discovery and preclinical PK into FIH studies. In this role, you will support IND preparation, work with the clinical team to set first in human dosing strategies and continue with the teams into early development to support clinical PKPD and optimal dose selection. Position Description
Reporting to the VP of Translational Science, the Director/Sr. Director, Clinical Pharmacology will work in our early development teams on small molecule programs, with responsibility for the Clinical Pharmacology package, connecting the project from discovery and preclinical PK into FIH studies. In this role, you will support IND preparation, work with the clinical team to set first in human dosing strategies and continue with the teams into early development to support clinical PKPD and optimal dose selection.
Primary Responsibilities
As part of the development team, you will provide expertise in the overall preclinical and clinical development of small molecule programs, in particular the design and oversight for clinical pharmacology. Provide input into clinical development plans, clinical study protocols and reports, Investigators Brochures and the pharmacology section of INDs. Interact with regulatory agencies (US and ex-US) as needed. You will be accountable for all clinical pharmacology aspects of compounds in the discovery to early development stage. You will be responsible for oversight and interaction with consultants and vendors assigned to support clinical pharmacology tasks including preclinical PK, PKPD, modeling, and clinical assay development.
Qualifications And Requirements
PhD or PharmD in pharmacology, or related discipline preferred. 12+ years of experience in Clinical Pharmacology supporting early development in a biotech or pharmaceutical organization. Prior, robust clinical pharmacology experience with small molecules is required. Experience in therapeutic areas related to pain management preferred. Experience with regulatory submissions in early development is required.
Location:
This position can be located in Thousand Oaks, CA or the San Francisco Bay Area Seniority level
Seniority level
Director Employment type
Employment type
Full-time Job function
Job function
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
3 days ago Be among the first 25 applicants Position Description
Reporting to the VP of Translational Science, the Director/Sr. Director, Clinical Pharmacology will work in our early development teams on small molecule programs, with responsibility for the Clinical Pharmacology package, connecting the project from discovery and preclinical PK into FIH studies. In this role, you will support IND preparation, work with the clinical team to set first in human dosing strategies and continue with the teams into early development to support clinical PKPD and optimal dose selection. Position Description
Reporting to the VP of Translational Science, the Director/Sr. Director, Clinical Pharmacology will work in our early development teams on small molecule programs, with responsibility for the Clinical Pharmacology package, connecting the project from discovery and preclinical PK into FIH studies. In this role, you will support IND preparation, work with the clinical team to set first in human dosing strategies and continue with the teams into early development to support clinical PKPD and optimal dose selection.
Primary Responsibilities
As part of the development team, you will provide expertise in the overall preclinical and clinical development of small molecule programs, in particular the design and oversight for clinical pharmacology. Provide input into clinical development plans, clinical study protocols and reports, Investigators Brochures and the pharmacology section of INDs. Interact with regulatory agencies (US and ex-US) as needed. You will be accountable for all clinical pharmacology aspects of compounds in the discovery to early development stage. You will be responsible for oversight and interaction with consultants and vendors assigned to support clinical pharmacology tasks including preclinical PK, PKPD, modeling, and clinical assay development.
Qualifications And Requirements
PhD or PharmD in pharmacology, or related discipline preferred. 12+ years of experience in Clinical Pharmacology supporting early development in a biotech or pharmaceutical organization. Prior, robust clinical pharmacology experience with small molecules is required. Experience in therapeutic areas related to pain management preferred. Experience with regulatory submissions in early development is required.
Location:
This position can be located in Thousand Oaks, CA or the San Francisco Bay Area Seniority level
Seniority level
Director Employment type
Employment type
Full-time Job function
Job function
Other Referrals increase your chances of interviewing at Latigo Biotherapeutics, Inc. by 2x Director, Drug Safety & Clinical Development
Westlake Village, CA $176,000 - $264,000 1 week ago Senior/Executive Medical Director, Global Clinical Development
Westlake Village, CA $250,000 - $310,000 1 month ago Associate Director, Bioanalysis (CPSS Cell Therapy)
Santa Monica, CA $134,578.41 - $201,867.59 2 days ago Executive Director, Clinical Development - Rare Disease
Associate Director, Bioanalysis Lab Lead (CPSS Cell Therapy)
Santa Monica, CA $134,578.41 - $201,867.59 2 days ago Senior Medical Director, Clinical Development (MD) Rheumatology
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr