Vice President, Preclinical & Clinical Development
Listed on 2026-08-05
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Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Science/ Research
Vice President, Preclinical & Clinical Development
Cali
-Skaggs is seeking an accomplished and strategic Vice President of Preclinical Development to lead and integrate in vivo pharmacology, efficacy, toxicology, and ADME/PK across research and development programs. This individual will play a critical leadership role in advancing early-stage, novel therapeutic candidates from discovery through IND filing and into early clinical development.
The successful candidate will bring deep scientific expertise, strong people leadership, and a proven track record of translational success in both small molecule and biologics drug development. This is a senior, on-site leadership role responsible for guiding multidisciplinary teams and shaping Cali
-Skaggs' pharmacology strategy across multiple programs.
Responsibilities and duties include:
- Provide scientific and strategic leadership for all in vivo pharmacology, efficacy, toxicology, and ADME/PK activities.
- Lead pharmacology efforts across the full R&D continuum, from target validation and lead optimization through IND-enabling studies and early clinical development.
- Design, interpret, and integrate pharmacology and toxicology data to inform candidate selection, dose selection, and clinical translation.
- Partner closely with chemistry, biology, DMPK, CMC, regulatory, and clinical teams to ensure cohesive and efficient program advancement.
- Ensure key activities are conducted in compliance with GLP, as appropriate for stage of development.
- Serve as a key contributor to IND filings, regulatory interactions, and development strategy.
- Oversee and manage multiple CROs supporting outsourced pharmacology, toxicology, and ADME/PK activities, ensuring scientific quality, timelines, and budget adherence.
- Build, mentor, and lead a high-performing team, fostering scientific rigor, collaboration, and accountability.
- Present program strategy, data, and recommendations to internal and external review boards, and maintain close, ongoing communication with executive leadership and key stakeholders.
- Provide scientific input to portfolio strategy, program reviews, and senior leadership decision-making.
- Details of established essential functions for this position will be addressed/discussed during the interview process.
Position requirements include:
- PhD. in Pharmacology, Toxicology, Pharmaceutical Sciences, Cell Biology or a closely related field.
- 10+ years of experience in a pharmaceutical or biotechnology industry setting.
- Demonstrated success advancing both small molecules and biologics through discovery, IND-enabling studies, and early clinical development.
- Extensive hands-on and leadership experience in in vivo pharmacology, efficacy models, toxicology, and ADME/PK.
- Proven ability to lead large, multidisciplinary teams and manage complex programs in a fast-paced R&D environment.
- Strong working knowledge of GLP and GMP regulations and their application to preclinical and early clinical drug development.
- Strong understanding of regulatory expectations for preclinical development and IND submission.
- Proven experience managing multiple CROs and outsourced pharmacology programs.
- Excellent scientific judgment, communication skills, and ability to influence across functions.
- Prior experience in a senior leadership or executive-level role strongly preferred.
- This position requires full-time, on-site presence at Cali
-Skaggs. - Ability to lead, inspire, and manage a large organization while maintaining hands-on scientific engagement.
Comprehensive benefits include:
- Eligible for both Short‑Term (STIP) and Long‑Term (LTIP) Incentive Bonus programs, offering a highly competitive total rewards package.
- Employer Contributed Retirement Plan – Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars)
- Full suite of health and welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more
- Access to Flexible Spending Accounts (Medical/Dependent Care)
- Competitive…
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