Director/Sr. Director, Clinical Pharmacology
Latigo Biotherapeutics, Inc.
Date: 1 week ago
City: Thousand Oaks, CA
Salary:
$235,000
-
$245,000
per year
Contract type: Full time
Company Description:
Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation.
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:
Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation.
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, Investigator’s 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.
- 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.
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