ASSOCIATE DIRECTOR, TRANSLATIONAL SCIENCE

2 weeks ago

CA United States Acelyrin, Inc. Full time
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.

We are looking for a collaborative, positive, self-driven, individual with the ability to work seamlessly within a hybrid work environment. The successful candidate will exhibit strong technical expertise, , and a willingness to work both strategically and hands-on. As ACELYRIN grows, we require individuals who can work within cross-functional teams that combine internal staff, contractors, consultants, and other external resources to deliver against aggressive development timelines.

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
  • Hands-on 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 face-to-face engagement and troubleshooting
  • Able to work independently and complete projects with minimal oversight, escalating issues to management with discretion
  • Motivated and results-oriented individual with outstanding work ethic, able to perform in a fast-paced environment
  • Ability to multi-task 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

ACELYRIN, INC, does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.

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