Title: Clinical Scientist IV
Seeking a candidate with a bachelor's degree and preferably an advanced clinical/science degree (e.g. PharmD, PhD, MPH) with at least 4 years of industry experience to work on a late stage molecule for ulcerative colitis and Crohn's disease. Multiple ongoing Phase 3 studies with data readouts for ulcerative colitis next year.
Cross-Functional Team Membership
Participates in the relevant Clinical Science Team (CST)
Participates as a standing member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient clinical development (CD) plan execution
Clinical Development Plan Implementation
- Provides clinical support across all relevant studies and programs:
- Participates in ongoing CST and relevant sub-team meetings, other interactions and communications
- Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
- Responds to questions from other internal and external parties regarding assigned studies and programs
- Helps coordinate the successful completion of documents with other groups
- Collaborates with clinical science, clinical operations, data management and other groups to conduct clinical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc.
- Works with clinical science, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
- Assists in responding to health authority inquiries
- Works closely with clinical science, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting
- Supports clinical science, regulatory and other internal partners/stakeholders with completion of clinical study reports
- Completes other special projects, as and when assigned, or otherwise requested
- Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines
Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements.
QUALIFICATIONS & EXPERIENCE:
- Bachelor's degree required (life science preferred)
- Advanced clinical/science degree is preferred (e.g. PharmD, PhD, MPH)
- 4 or more years pharma/biotech industry experience
- Data listing review experience
- Experience working on a clinical team (or equivalent)
- Has extensive knowledge of clinical research and has successfully worked across Phase II – III drug development projects
- Broad experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
- Comprehensive understanding of product and safety profiles
- Well versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
- Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Company Values.
- Outstanding attention-to-detail
- Has knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
- Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target accomplishment of such
- Strong interpersonal, verbal communication and influencing skills
- Outstanding written communication skills
- Strong business presentation skills; is comfortable and effective when presenting to others, internally or externally
- Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others. Has proven experience and skills working with multidisciplinary teams.
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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