Advanced Clinical

Clinical Scientist This role partners closely with Clinical Development Leads to review clinical protocols, support adherence to regulatory and GCP standards, and manage safety and efficacy data. The Clinical Scientist collaborates cross-functionally with Clinical Operations, Data Management, and Biometrics. The ideal candidate holds a graduate degree and is passionate about advancing innovative therapeutics in the neuromuscular disease space.Key Responsibilities Support and enhance Medical Monitor oversight for clinical trials, ensuring appropriate delegation and execution of medical monitoring activities.Assist Clinical Development Leads in implementing development plans for novel drug candidates within cross-functional clinical trial teams.Partner with Clinical Operations, Data Management, and Biometrics to develop study tools, data outputs, and study plans.Collaborate with Clinical Development Leads to review clinical trial documents, incorporating therapeutic direction and patient selection strategies as appropriate.Oversee clinical trial conduct to ensure compliance with GCP, patient eligibility requirements, and protocol adherence.Lead medical data review, cleaning, analysis, interpretation, and communication for ongoing and completed studies.Support safety data review and ensure timely identification and resolution of safety issues as assigned.Contribute to the development and review of regulatory documents and communications, including INDs, IBs, annual reports, CSRs, abstracts, manuscripts, and presentations.Follow and help implement quality standards and SOPs across clinical development activities.Desired Education and Skills EducationGraduate degree preferred (MD, RN, PhD, PA, NP, PharmD).Bachelor's degree considered with relevant industry experience.ExperienceMinimum of 3–5 years of industry experience in drug development.Medical monitoring experience required.Direct patient care experience preferred.Regulatory KnowledgeStrong understanding of the regulatory environment, including experience responding to Health Authority requests and timelines.Data ExpertiseDemonstrated proficiency in medical data review, cleaning, analysis, interpretation, and communication.Therapeutic Area ExperienceExperience with genetic therapeutics preferred.Additional experience in non-DMD therapeutic areas (e.g., Immunology) is a plus.Core SkillsAbility to manage high-priority activities independently while engaging senior leadership appropriately.Working knowledge of GVP, FDA, and EMA regulations and guidelines.Excellent interpersonal and communication skills.Proficiency in PowerPoint, Excel, and Microsoft Office.TravelWillingness to travel as needed.Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.