What are the responsibilities and job description for the Senior Clinical Scientist / AD, Clinical Scientist position at Star Therapeutics?
Position Summary
The Senior Clinical Scientist / AD Clinical Scientist will be responsible for supporting or leading tasks related to Clinical Science deliverables across the various stages of clinical development—study design and execution, data analysis, and regulatory filings—in accordance with program needs. These include drafting key documents to support study conduct; reviewing and interpreting clinical data; and leveraging relationships with external parties (KOLs/Investigators).
The position will also have the opportunity to take on the role of Medical Monitor for a study, based on their capabilities and clinical experience/expertise.
The right candidate is someone who has a strong scientific background, thinks innovatively, works effectively in small and motivated teams, has a passion to bring potentially transformative therapies to patients, and thrives when supported by mentors and colleagues to take ownership of their contributions to both the molecule and Clinical Science teams.
This is a new position due to growth of the company and will report to the Vice President, Clinical Science.
Primary Responsibilities
- Develop and/or contribute to key documents to support the components of trial execution and regulatory submissions (e.g., IND Annual Reports, Investigator Brochures, Briefing Books, and Pediatric Plans)
- Develop scientific rationale for methods, design, and implementation of clinical protocols, data collection systems, and final reports
- Act as the scientific subject matter expert and primary contact for the assigned clinical study; take a proactive approach to identifying issues and mitigating risk
- Conduct periodic review of protocol deviations in collaboration with the Clinical Operations Study Lead or designee
- Perform clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety, data quality, and appropriate interpretation for assigned study/studies.
- Lead and participate in operational excellence projects and audit readiness activities, as appropriate
- Initiate and provide scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions; and other key study deliverables
- Contribute to and review Clinical Study Report (CSR) writing (review final tables, listings, and figures; work with medical writer to review & revise CSR document; draft discussion and conclusions; and participate in comment resolution meetings)
- Support the design, update, and implementation of Clinical Development Plans (CDPs) and work with Project Management to ensure progress is in line with current plans and timelines
- Collaborate with translational research on biomarker selection and data interpretation, design of non-clinical experiments, and analysis of subject samples to support clinical efficacy and safety evaluation
- Stay up to date with advances in the rare blood disorders literature, including mechanism of action, diagnostic tests, standard of care treatments, drug development trends, and regulatory requirements
- Assist with content development and attend and present at Investigator Meetings and other internal and external stakeholder meetings, as needed
- Present study updates and topline results to Clinical Development leadership, as needed
- Performs other related duties as assigned
Qualifications / Skills
- Proficient with Microsoft Word, Excel, and PowerPoint
- Ability to write clearly and concisely
- Ability to present with clarity and compellingly
- Detail-oriented
Education & Professional Experience
- Advanced science/health degree, such as PhD, PharmD, MSN
- At the Senior Clinical Scientist level, the position reuqires at least 5 years of experience within Clinical Science, preferably in late-stage clinical development programs. At the AD, Clinical Scientist level, the position requires 6-8 years of experience, preferably in late-stage clinical development programs.
- Proficient in clinical research regulatory requirements (e.g., GCP and ICH)
- Prior successful IND/CTA and/or NDA/BLA/MAA submission preferred. Experience supporting and participating in regulatory inspections desired.
Salary : $132,000 - $195,000
