1 DNA way South San Francisco, CA 94080
Bayside Solutions is seeking a Clinical Scientist to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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.
- Participates in ongoing CST and relevant sub-team meetings, other interactions and communications
- 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
- 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, client Standard Operating Procedures (SOPs) and other guidelines
Summary of Qualifications:
- 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)
- 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 and written communication and influencing 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