Lead Clinical Scientist

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: Remote; Agoura Hills | South San Francisco, California

Job Title: Clinical Scientist, (Senior Clinical Scientist Associate Director)

Reports To: Senior Medical Director

Function: Clinical development

Job Type: Full time

Position Summary:

The Clinical Scientist works in a fast-paced, matrix environment and contributes to the scientific, clinical, and operational scope of Lonigutamab, a novel biological that can be subcutaneously delivered for Thyroid Eye Disease (TED). This role will work with the cross-functional teams for the design, execution, and monitoring of clinical studies, as well as assist with data review, interpretation, and communication to both internal and external stakeholders.The ideal candidate will have a strong background in clinical research or clinical safety. The position reports to the Senior Medical Director, Clinical Development.

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, analytic skills, and a willingness to work hands-on. As ACELYRIN grows, we require individuals who can work seamlessly within cross-functional teams that combine internal staff, contractors, consultants, and other external resources to deliver against aggressive development timelines.

Responsibilities:

• Ensuring high quality clinical trial conduct and data collection through ongoing clinical data monitoring (incl. safety, efficacy, ePRO, imaging, and PK/biomarker data)
• Reviewing and analyzing clinical data at all phases for Phase 1/2 up to Phase 3 trials (e.g. safety reviews, TFL reviews)
• Supports key activities such as data generation and review for Data Monitoring Committee (DMC), Safety Review Committees (SRC), or other applicable data review committees
• Working closely with and escalate topics to medical lead/medical monitor, including monitoring safety of trials, protocol deviation review, medical coding review
• Contributing to development or amendment of clinical protocols and other study documents (e.g. ICF, pharmacy manual, other study related materials)
• Drafting clinical sections of CSR, IB, responses to regulatory authorities, and other key clinical and regulatory documents in collaboration with clinical development
• Ensure compliance in accordance with regulatory requirements (e.g. FDA, EMEA, ICH and GCP) as well as applicable SOPs regarding clinical safety
• Partnering with other functions (e.g. clinical operations, pharmacovigilance, data management, biostats) for successful execution of study statistical analysis plans
• Support data review and cleaning for abstracts (e.g. for conferences) and manuscripts (e.g. for peer-reviewed journals) in collaboration with clinical development, medical affairs and other relevant functions (following relevant guidelines e.g. GPP, ICMJE, ISMPP)

• Maintains working knowledge of the therapeutic disease area(s) and drug candidate

• Conduct literature reviews to support clinical activities as needed
• Travel: up to 15%

Qualifications and Skills Required:

• BS/MS degree (science based) is required with RN, PharmD, PhD or MD training preferred
• 5 years of industry experience (pharmaceutical or biotechnology), preferably in clinical science or related field
• Extremely detail-oriented and experienced in analyzing and interpreting complex clinical data (e.g. adverse events, medical history, concomitant medication, efficacy endpoints) and to summarize in a concise and accurate manner
• Experience in protocol authoring, study startup, study execution/monitoring and data review activities

• Excellent interpersonal, organizational, written and verbal communication skills

• Experience contributing to global regulatory filings is a plus
• Therapeutic experience in rare diseases or ophthalmology is a plus

Essential behaviors and ways of working:

• Proactive and positive (can do) attitude

• Collaborative nature; ability to prioritize tasks as needed by the study team

• Ability to work independently in the background as well as representing Clinical Science with internal (e.g. program management, PV, DM, biostats, medical affairs) and external stakeholders (e.g. CROs, PIs, study sites, third-party vendors, committees)

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.