Associate Director, Translational Science - Agoura Hills, United States - ACELYRIN, INC.

ACELYRIN, INC.
ACELYRIN, INC.
Verified Company
Agoura Hills, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
At ACELYRIN, INC the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency.

Our key value of courageous caring means putting patients first and having the courage needed to quickly solve challenging issues.

We strive to redefine what is possible and quickly bring innovative therapies to bear against serious diseases.


Location:
Agoura Hills, CA


Job Title:
Associate Director of Bioanalytical Operations

Reports To:
VP, Translational Science and Biology Research

Function:
Lead Translational Science and Research


Job Type:
Full Time

**Position Summary: As a member of ACELYRIN ́s Translational Science team, this individual will be responsible for the operational aspects of bioanalysis supporting pharmacokinetic, pharmacodynamic and anti-drug antibody assays performed at Contract Research Organizations (CRO) for biologics. Specifically, responsibilities will include obtaining quotations and establishing contracts for new assays and sample analysis, managing timelines at the CRO and coordinating with internal teams, reviewing validation and sample analysis reports, tracking spend for assay development/validation/sample analysis, and managing critical reagents that are used in the bioanalytical assays. This individual should have experience developing/validating ligand-based PK, PD, and ADA assays, a strong understanding of bioanalytical regulatory guidance documents, managing bioanalytical projects performed at CROs, and managing critical reagents. Additional experience in cell-based assays, contributing to regulatory documents, and responding to agency requests is desirable.


Responsibilities:


  • Manage all aspects of bioanalytical operations performed at CROs supporting development of biologics
  • Manage development, validation, and execution of pharmacokinetics, pharmacodynamics, and biomarker assays
  • Manage CRO timelines and coordinate with internal teams to ensure team and company goals are achieved
  • Manage critical reagents for bioanalytical assays
  • Provide scientific and strategic input to support assay development
  • Support the operational process for building scientific rationale for new clinical indications
  • Review clinical bioanalytical data and contribute to interpretation and external communication efforts
  • Coordinate the process for efficiently contributing to regulatory filings, responding to agency requests, and communicate scientific findings
  • Manage contractors, consultants, and other external resources (as needed) to meet team and corporate goals

Qualifications and Skills Required:


  • A PhD (or equivalent) in a relevant discipline and at least 5 years relevant experience, an MS and at least 10 years of relevant experience or a BS and 12 years of relevant experience
  • Experience managing CROs performing bioanalysis for biologics
  • Handson experience developing/validation ligand based assays
  • Formal training or experience in immunology is preferred
  • Project management training or related experience is preferred
  • Proven track record of accomplishments within therapeutic discovery and development including: various aspects of bioanalysis, biomarker development and translational science
  • Experiences supporting the development of biologics
  • Experience contributing to relevant sections of clinical and commercial regulatory submissions, e.g. INDs, IBs, protocols, and BLA is preferred
  • Ability to travel domestic or internationally to CRO laboratories as needed for facetoface engagement and troubleshooting
  • Able to work independently and complete projects with mínimal oversight, escalating issues to management with discretion
  • Motivated and resultsoriented individual with outstanding work ethic, able to perform in a fastpaced environment
  • Ability to multitask and adjust priorities quickly while working under tight timelines
  • Strong oral and written communicator with concomitant interpersonal skills
  • Demonstrated ability to work cross functionally in a matrixed environment
  • Demonstrated ability to evolve and develop new skills and capabilities within a growing organization

Essential behaviors and ways of working:

  • Ability to work independently as well as cross-functionally
  • Strong oral and written communication skills
  • Results and Action Oriented
  • Ability to Deal with Ambiguity
  • Demonstrated Strategic and Problem Solving in matrixed environment
  • Demonstrated Functional and Technical Skills for nonclinical and clinical development
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