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Associate Director, Translational Science - Agoura Hills, United States - ACELYRIN, INC.
Description
Job DescriptionJob Description Salary:
$190,000 - $215,000
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.
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.
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.
We are looking for a collaborative, positive, self-driven, individual with the ability to work seamlessly within a hybrid work environment.
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.
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