Acelyrin, Inc. Agoura Hills , CA 91301
Posted 3 weeks ago
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: Senior Director, Translational Science
Reports To: Vice President, Translational Science and Biology Research
Function: Lead Translational Science and Research
Job Type: Full Time
Position Summary:
A member of ACELYRIN´s Translational Science team is a key contributor to the design, execution and analysis of toxicology studies, bioassay, and biomarkers supporting clinical development. Activities include critical oversight of nonclinical toxicology strategy and execution and leading the development, validation and execution of bioassays to support PK and PD assays. Establishing strategic collaborations with investigators to explore disease relevant model systems and managing CROs will be key to success. We require an individual who can contribute to regulatory filings, respond to agency requests, and communicate scientific findings as a primary author.
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, leadership and management skills, 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:
Lead the translational strategy and execution for individual therapeutics
Oversee nonclinical toxicology strategy and execution across a pipeline of therapeutics
Manage development, validation, and execution of assays to support pharmacokinetics, pharmacodynamics, and biomarkers
Identify and manage vendors to support toxicology and translational science efforts
Manage timelines, budgets and key translational science deliverables to support clinical development and product development team deliverables
Provide scientific and strategic input to support clinical development
Identify investigators and establish collaborations to build scientific rationale for new clinical indications
Review clinical data and contribute to interpretation and external communication efforts
Contribute to regulatory filings, respond to agency requests, and communicate scientific findings as a primary author
Manage contractors, consultants, and other external resources (as needed) to deliver against aggressive development timelines
Qualifications and Skills Required:
A PhD or MD (or equivalent) in a relevant discipline, with at least 15 years of biotech/pharmaceutical experience
Formal training or extensive experience in immunology and developing therapeutics against immunologic targets
Proven track record of accomplishments within therapeutic discovery and development including: toxicology, translational science, bioassay and biomarker development
Experiences supporting the clinical development of biologics
Past experience as primary author of relevant sections of clinical and commercial regulatory submissions, e.g. INDs, and BLA's
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 deadline
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
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.
Acelyrin, Inc.