Non-Clinical Development Manager
Alkahest, Inc.
San Carlos, EEUU
hace 3 días

Description

Uniquely positioned to enhance quality of life in aging, at Alkahest, we are pioneering science that is rapidly being translated to the clinic.

Our approaches utilize in vivo, in vitro, proteomic, and molecular techniques to identify new therapeutics and apply them to patients.

We are seeking a highly motivated and driven professional who will be key in coordinating our nonclinical IND-enabling studies.

The role will in part require management of in vitro and in vivo studies at external CROs and interacting with consultants to develop and execute studies for therapeutic advancement.

Management of external studies will require knowledge of PK, ADME, toxicology, and pharmacology study designs to provide valuable input to the conduct of these critical studies.

The role may also provide an exciting opportunity to contribute to internal research refining biological mechanisms, resulting in publications for discovery- and clinical-stage programs.

The role requires dedication, flexibility, excellent communication and organization, and will interact with cross-functional teams comprising clinical operations, medical, research, and regulatory affairs in order to advance Alkahest’s drug development programs.

Alkahest offers a competitive compensation and benefits package, opportunities for career growth and development, and a work environment that is collaborative, collegial, and fun.

RESPONSIBILITIES :

Specific responsibilities include, but are not limited to :

  • Managing external CROs for conduct of DMPK, ADME, toxicology, and safety pharmacology studies, including reviewing protocols, study monitoring, and reviewing final reports
  • Maintaining familiarity with current scientific literature and current regulatory guidances
  • Investigating and developing new methods and technologies for project advancement
  • Assisting in nonclinical responses to regulatory authorities
  • Assisting in writing of nonclinical sections of Investigator Brochures
  • Assisting in nonclinical aspects of due diligence processes
  • REQUIREMENTS :

  • Bachelor’s degree from an accredited college / university in a field related to biomedical research, cell biology, molecular biology, biochemistry, or neuroscience
  • Minimum of 8 years of progressively advancing academic or industry research experience
  • Minimum of 2 years of experience managing ADME, DMPK, toxicology, and safety pharmacology studies in an industry drug development program
  • Expertise in one of the following areas is an advantage : drug formulation, PKPD assay design, in vivo efficacy studies, in vitro assay development
  • Ability to work collaboratively and excellent interpersonal, verbal, and written communication skills
  • Attention to detail and strong organizational skills
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