Senior Clinical Scientist

Atrium Therapeutics; San Diego (CA); On-site; USD 185,000 - 205,000; Full time

Benefits offered by this job

Stock options and RSUs

401(k) with employer match

Wellness program – medical, dental, V​

Unlimited PTO including summer &冬季休假

Job summary

Atrium Therapeutics is a biopharmaceutical company focused on RNA therapeutics for heart disease. We seek a Senior Clinical Scientist to advance development plans and clinical trials in line with ICH/GCP standards.

The role involves analyzing safety and efficacy data, supporting regulatory submissions, and collaborating with cross-functional teams to meet milestones in a fast-paced environment. Advanced degree and 8+ years in pharma/biotech with rare disease or cardiology experience are

Qualifications

• Advanced degree required (PhD, MD, or PharmD).
• Minimum 8 years of relevant experience, including at least 3 years in clinical science.
• Rare disease and/or cardiology experience.
• Expert knowledge of clinical trial design; ability to assimilate technical and scientific information.
• Experience contributing to clinical and regulatory documents.
• Excellent interpersonal, written and verbal communication, presentation, organizational, and workload-prioritization skills.

Responsibilities

• Plan and design clinical studies in accordance with corporate objectives.
• Provide literature searches, interpretation of literature, and evaluation of technologies for clinical strategy.
• Contribute to clinical oversight and review of trial data, including efficacy and safety data.
• Support the Study Medical Monitor in tracking laboratory results and communicating with site staff.
• Collaborate with Clinical Operations to translate protocols into operational deliverables and study plans.
• Draft, review and revise clinical documents including protocols, study reports, and regulatory submission materials.
• Contribute to cross-functional and clinical meetings (study team, investigator, site initiation, steering committee).
• Complete all training requirements relating to security, data protection, GxP and SOPs.

Skills

Clinical science

Regulatory knowledge

Data analysis

Communication

Education

Advanced degree (PhD/MD/PharmD)

Job description

Atrium is a biopharmaceutical company pioneering delivery of RNA therapeutics to the heart to transform the standard of care for people living with cardiomyopathies. Our proprietary technology leverages the targeted RNA delivery platform initially designed at Avidity, which combines the tissue selectivity of mAbs and other targeted delivery ligands with the precision of oligonucleotides.

This unique combination is designed to allow selective targeting of the underlying genetic drivers of disease that were previously undruggable. Through targeted, non-viral delivery of siRNA to cardiac tissues, our approach has the potential to overcome key limitations of nonspecific viral and nanoparticle-based delivery systems, including challenges related to tissue specificity, immunogenicity, and redosing.

Position Summary

Atrium Therapeutics is seeking a Senior Clinical Scientist to work with key internal stakeholders on the development and execution of clinical development plans and clinical trials. In support of the Global Development Lead and cross-functional program teams, this role contributes to the analysis and interpretation of safety and efficacy data; supports regulatory submissions, publications, and presentations; and helps achieve program goals and milestones in compliance with applicable regulations and ICH/GCP.

Job Responsibilities

• Contribute to the planning and design of clinical studies in accordance with corporate objectives.
• Provide scientific support through literature searches, interpretation of scientific literature, and evaluation of technologies that aid clinical strategy, study implementation, and due diligence.
• Contribute to clinical oversight and scientific review of trial data, including the analysis and interpretation of efficacy and safety data.
• Support the Study Medical Monitor in tracking laboratory results and communicating with site staff.
• Collaborate with Clinical Operations to translate protocols into operational deliverables, review study data, and prepare or review study plans.
• Draft, review and revise clinical documents, including protocols, clinical study reports, informed consent forms, investigator brochures, annual reports, and regulatory submission materials.
• Contribute to cross-functional and clinical meetings, including study team, investigator, site initiation, ad hoc, and steering committee meetings.
• Complete all training requirements, including relating to security, regional data protection requirements, GxP and SOPs in a timely manner.

Education and Experience Requirements

• Advanced degree required (PhD, MD, or PharmD).
• Minimum of 8 years of relevant experience, including at least 3 years of clinical science experience in a pharmaceutical or biotechnology environment.
• Rare disease and/or cardiology experience.
• Expert knowledge of scientific principles and concepts; publication, peer-review, or scientific conference presentation experience.
• Knowledge of clinical trial design; ability to assimilate technical and scientific information; and proficiency in data analysis and interpretation.
• Experience contributing to clinical and regulatory documents.
• Excellent interpersonal, written and verbal communication, presentation, organizational, and workload-prioritization skills.
• Ability to perform in a deadline-driven environment, support multiple projects simultaneously, and work effectively on cross-functional teams.

What We Provide

• The base salary range for this role is $185,000-$205,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Atrium offers competitive compensation and benefits which include stock options & RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, LTD, and unlimited of time off including summer & winter breaks.
• A commitment to learning and development which includes a variety of programming internally developed by and for Atrium employees, opportunities for job-specific training offered by industry, and an education reimbursement program.