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:
Medical Monitoring- Support and enhance Medical Monitor oversight for clinical trials, ensuring appropriate delegation and execution of medical monitoring activities.
Clinical Development Strategy- Assist Clinical Development Leads in implementing development plans for novel drug candidates within cross-functional clinical trial teams.
Cross-Functional Collaboration- Partner with Clinical Operations, Data Management, and Biometrics to develop study tools, data outputs, and study plans.
Clinical Document Development- Collaborate with Clinical Development Leads to review clinical trial documents, incorporating therapeutic direction and patient selection strategies as appropriate.
Trial Conduct Oversight- Oversee clinical trial conduct to ensure compliance with GCP, patient eligibility requirements, and protocol adherence.
Medical Data Management- Lead medical data review, cleaning, analysis, interpretation, and communication for ongoing and completed studies.
Safety Monitoring- Support safety data review and ensure timely identification and resolution of safety issues as assigned.
Regulatory Documentation- Contribute to the development and review of regulatory documents and communications, including INDs, IBs, annual reports, CSRs, abstracts, manuscripts, and presentations.
Quality & Compliance- Follow and help implement quality standards and SOPs across clinical development activities.
- Desired Education and Skills
Education- Graduate degree preferred (MD, RN, PhD, PA, NP, PharmD).
- Bachelor’s degree considered with relevant industry experience.
Experience- Minimum of 3–5 years of industry experience in drug development.
- Medical monitoring experience required.
- Direct patient care experience preferred.
Regulatory Knowledge- Strong understanding of the regulatory environment, including experience responding to Health Authority requests and timelines.
Data Expertise- Demonstrated proficiency in medical data review, cleaning, analysis, interpretation, and communication.
Therapeutic Area Experience- Experience with genetic therapeutics preferred.
- Additional experience in non-DMD therapeutic areas (e.g., Immunology) is a plus.
Core Skills- Ability 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.
Travel- Willingness to travel as needed.
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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.
