- 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
- 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
- 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
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Senior Director, Translational Science - Agoura Hills, United States - ACELYRIN, INC.
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:
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:
Qualifications and Skills Required:
Essential behaviors and ways of working:
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.
