Clinical Scientist

company banner
Advanced Software Talent
Life sciences, Clinical research, Pharmaceutics, Good Clinical Practice, Communication skills, Biotechnology, 4 or more years pharma/biotech industry experience, Has extensive knowledge of clinical research and has successfully worked across Phase II III drug development projects
Contract W2, 12 Months
Depends on Experience
Work from home not available Travel not required

Job Description

Only local San Francisco Bay Area candidates!

Direct W2 employees only!

JOB DESCRIPTION

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:

o Participates in ongoing CST and relevant sub-team meetings, other interactions and communications

o Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

o Responds to questions from other internal and external parties regarding assigned studies and programs

o Helps coordinate the successful completion of documents with other groups

o 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.

o Works with clinical science, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries

o Assists in responding to health authority inquiries

o Works closely with clinical science, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting

o Supports clinical science, regulatory and other internal partners/stakeholders with completion of clinical study reports

o Completes other special projects, as and when assigned, or otherwise requested

o Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines

SELECTION CRITERIA:

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)

ABILITIES:

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, Roche 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

Posted By

Susanne Malabey

Burlingame, CA, 94010

Contact


Company Information

Since 1979, Advanced Software Talent has developed programs that are specifically designed to find and deliver world-class talent to technology-driven companies. With three decades of trendsetting work in our back pocket, we have earned a reputation for honesty, quality, and integrity.
Dice Id : atstaff
Position Id : sfcadm@advance
Originally Posted : 4 weeks ago

Similar Positions at Advanced Software Talent

SAS Clinical Programmer
  • South San Francisco, CA
  • 4 hours ago
Clinical Study Manager
  • South San Francisco, CA
  • 4 hours ago
Data Solutions Architect
  • San Carlos, CA
  • 4 hours ago
Business Analyst/Informatics Business Analyst
  • South San Francisco, CA
  • 4 hours ago
Data Analyst
  • South San Francisco, CA
  • 4 hours ago