Associate Director, Translational Science

3 weeks ago

Agoura Hills, 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.

  • Senior Director, Translational Science

    3 weeks ago

    Agoura Hills, 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...

  • Senior Director, Translational Science

    3 weeks ago

    Agoura Hills, 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...

  • Housekeeping Associate

    3 weeks ago

    Agoura Hills, United States Varenita of Westlake Full time

    Are you a Housekeeper looking for a new opportunity that will give you joy and fulfillment by being able to help others? Do you enjoy working with seniors? If so, we may have the perfect opportunity for you! We are currently accepting applications for Housekeepers to help keep our beautiful senior living community clean and tidy so that our residents can...

  • Housekeeping Associate

    3 weeks ago

    Agoura Hills, United States Varenita of Westlake Full time

    Are you a Housekeeper looking for a new opportunity that will give you joy and fulfillment by being able to help others? Do you enjoy working with seniors? If so, we may have the perfect opportunity for you! We are currently accepting applications for Housekeepers to help keep our beautiful senior living community clean and tidy so that our residents can...

  • Research Associate I

    3 weeks ago

    Beverly Hills, United States CEDARS-SINAI Full time

    Job DescriptionPrincipal Investigator, Dr. Ritchie Ho is seeking a Research Associate I to join the team!Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will change how we diagnose and treat disease. As an international leader in biomedical research, we translate discoveries into successful...

  • Research Associate I

    4 weeks ago

    Beverly Hills, United States Cedars-Sinai Full time

    Job DescriptionPrincipal Investigator, Dr. Ritchie Ho is seeking a Research Associate I to join the team!Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will change how we diagnose and treat disease. As an international leader in biomedical research, we translate discoveries into successful...

  • Associate Director, Medical Strategy

    3 weeks ago

    Parsippany-Troy Hills, United States OPEN Health Full time

    Associate Director, Medical Strategy Reports to SVP, Medical StrategyJob SummaryThe Associate Director, Medical Strategy is responsible for providing strategic medical and tactical direction to support all of OPEN Health’s Scientific Communications teams in (1) the development of strategic medical plans and multi-stakeholder scientific communication plans,...

  • Lvn Home Health Nurse

    2 days ago

    Agoura Hills, United States Endless home health Full time

    Job Summary A Licensed Vocational Nurse provides practical nursing skills within the scope of nursing practice standards in collaboration with RN case managers/supervisors, teaches and educates patients and their families according to the established professional plan of care. Licensed Practical nursing is performed under the supervision of the assigned...

  • Research Associate II

    1 month ago

    Beverly Hills, United States Cedars-Sinai Full time

    Job DescriptionPrincipal Investigator, Gislaine Martins, PhD is looking for a Research Associate to join the team!When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai, and it’s just one of...

  • HR Director

    1 month ago

    Arden Hills, Minnesota, United States LandOLakes Full time

    As stated in the Land O'Lakes Job Posting policy, all employees who post for an internal opening must inform their current manager at the time they apply. ​Our growth relies on our extraordinary talent. Unlock your greatest potential at Land O'Lakes by continuing to make a difference, driving results and growing your career. HR Director - Business...

  • Research Associate I

    1 month ago

    Beverly Hills, United States Cedars-Sinai Full time

    Job DescriptionPrincipal Investigator, Gislaine Martins, PhD is looking for a Research Associate to join the team!When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai, and it’s just one of...

  • Biomedical Specialist

    7 days ago

    Beverly Hills, United States Cedars-Sinai Full time

    **Biomedical Specialist - Applied Genomics, Computation & Translational Core**: - Employer- Cedars-Sinai- Location- Beverly Hills, California- Salary- Competitive- Closing date- 15 Jul 2024- Discipline Health Science Job Type Researcher Employment - Hours Full time Duration Permanent Qualification PhD Sector Hospital- You need to sign in or...

  • Division Director, Youth Services

    3 hours ago

    Forest Hills, United States QUEENS COMMUNITY HOUSE Full time

    Queens Community House (QCH) is a multi-site, multi-service settlement house that serves the diverse population of Queens through a broad network of programs and services for Children and Youth, Adults and Families, and Older Adults. We are a modern interpretation of the traditional settlement house, bringing to our work current best practices,...

  • Research Associate I

    3 weeks ago

    Beverly Hills, CA, United States CEDARS-SINAI Full time

    Job DescriptionPrincipal Investigator, Dr. Ritchie Ho is seeking a Research Associate I to join the team!Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will change how we diagnose and treat disease. As an international leader in biomedical research, we translate discoveries into successful...

  • Senior Information Technology Manager

    1 month ago

    Agoura Hills, United States Cydcor Full time

    As the Sr. Manager of IT Development, one will be responsible for leading and inspiring a team of talented software engineers and overseeing the development efforts within Cydcor’s tech ecosystem. This role will play a vital role in driving innovation, fostering collaboration between technical and business teams, and designing, implementing, and...

  • Senior Information Technology Manager

    1 month ago

    Agoura Hills, United States Cydcor Full time

    As the Sr. Manager of IT Development, one will be responsible for leading and inspiring a team of talented software engineers and overseeing the development efforts within Cydcor’s tech ecosystem. This role will play a vital role in driving innovation, fostering collaboration between technical and business teams, and designing, implementing, and...

  • Senior Information Technology Manager

    1 month ago

    Agoura Hills, United States Cydcor Full time

    As the Sr. Manager of IT Development, one will be responsible for leading and inspiring a team of talented software engineers and overseeing the development efforts within Cydcor’s tech ecosystem. This role will play a vital role in driving innovation, fostering collaboration between technical and business teams, and designing, implementing, and...

  • Camp Director

    1 week ago

    Bloomfield Hills, United States Cranbrook Educational Community Full time

    Camp Director - Explore Camp Cranbrook Institute of Science's on-site Explore Camps give inquisitive campers the support they need to learn through doing. Campers work together to tackle activities, experiments, and investigations as they explore popular science topics in a unique and safe environment. For more information, please visit our website at 2024...

  • Research Associate I

    1 month ago

    Beverly Hills, United States Springer Nature Full time

    **Research Associate I - Ho Lab - Center for Neural Science and Medicine**: - Employer- Cedars-Sinai- Location- Beverly Hills, California- Salary- Competitive- Closing date- 17 Jun 2024- Discipline Health Science Job Type Researcher Employment - Hours Full time Duration Permanent Qualification PhD Sector Hospital- You need to sign in or create an...

  • Research Associate I

    3 weeks ago

    Beverly Hills, United States CEDARS-SINAI Full time

    Job DescriptionPrincipal Investigator, Lali Medina-Kauwe, PhD, is looking for a Research Associate to join the team!When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai, and it’s just one...