Senior Clinical Scientist
This leading biotechnology company that specializes in Rare Disease treatments utilizing Gene Therapy is hiring two Senior Clinical Scientists to support their programs within Huntington's and Pompe Disease.
Location: Starting 100% remote - candidates must be local to Philadelphia
The Sr. Clinical Scientist will lead or contribute in all areas of one or multiple clinical projects including, but not limited to, study planning, protocol development, medical monitoring, data interpretation and documentation. The Sr. Clinical Scientist will provide regulatory interaction, to include annual Investigator Brochure and regulatory document updates (e.g. DSUR, PRBER).
- Support the development of a Clinical Development Plan and its periodic reviews
- Support / manage preparation of materials for clinical committees such as the Steering Committee, DMC, Adjucation Committees, etc
- Support Clinical Development Lead/Study Physician on all trial related education for sites, staff, vendors and other Spark functions
- At the discretion of Clinical Development Lead, serve as trial representative for routine updates, such as investor relations or medical affairs information requests
- Ensure compliance with GCP, Clinical Operating Guidelines and Standard Operating Procedures
- Liaise and communicate with other functions including operations, biometrics, safety, regulatory affairs and medical affairs to coordinate the clinical efforts on project related issues.
- Contribute to the preparation of all clinical trial documents submitted to regulatory authorities and ethics committees/IRBs
- Be accountable to ensure correct data interpretation and appropriate content of interim and Final Study Reports for approval to internal governing entities, and assist in authoring these reports
- Experience with one of the following therapeutic areas required: MS, Respiratory, Internal Medicine, Rare Disease, OR Neurodegenerative/CNS with Clinical Outcomes.
- 3+ years as a Clinical Scientist
- 5+ years of clinical research experience
- Advanced degree is preferred such as PharmD, PHD, etc. but not required
- Minimum of a bachelors degree required
* Relocation assistance offered
* Currently remote due to Covid-19 pandemic
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.