Clinical Scientist

Clinical Scientist - Early Development

The Lead Clinical Scientist participates in the development of clinical strategies for assigned molecule(s)/indication(s) and is responsible for developing and ensuring effective and efficient execution of the Clinical Development Plan (CDP). Lead Clinical Scientists are expected to perform their responsibilities independently.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

Cross-Functional Team Leadership & People Management

  • Is a standing member of the Clinical Science Team and/or an ad hoc member of the Core Team or relevant sub-teams, and as such, presents and helps cross-functional team members synthesize/contextualize clinical data to facilitate discussion
  • Effectively represents Clinical Science (CS) on Protocol Execution Teams of assigned molecule(s) and ensures cross-functional integration, coordination and alignment to enable effective and efficient CDP execution, including regular review and analysis of protocol violations, authoring of study start-up documents required from Clinical Science, partnering with Data Management for case report form (CRF) design and instructions for use, review of all study documents requiring clinical expertise as identified by the Execution Team, and communication of milestone timelines to enable preparation of high quality data summaries to support regulatory and clinical documentation and/or team deliverables
  • Trains study site personnel on protocol execution
  • Contributes to clinical documentation of study execution including management of regulated documents, notes of clinical decisions, and study conduct that are considered permanent record
  • Plays an integral role as author or co-author and/or reviewer of any clinical sections of regulatory documents supporting ECD clinical trials, in collaboration with the Medical Director and the Medical Writer
  • In consultation with the Medical Monitor, is the primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors regarding the study protocol, informed consent, and patient-specific questions.
  • Responsible for the review, finalization, and update of information/data entered into clinical trials registry
  • (clinicaltrials.gov)
  • Partners with Data Management to develop novel electronic CRF and instructions for their use, the Data Quality Review Plan, and resolution of all clinical queries to sites
  • May participate in Health Authority interactions, as well as interactions with site IRBs/Ethics Committees and/or review committees
  • Collaborates with biostatistics to develop and QC data tables, listings, and figures and develops data-driven study specific analyses, as appropriate
  • Collaborates with Safety Science to identify and track any potential safety events within a given trial and/or across trials for assigned program(s)
  • Conducts medical data reviews
  • Collaborates with the Visual Analytics Manager (VAM) on data visualization

 

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,” all points listed below are considered minimum requirements.

QUALIFICATIONS & EXPERIENCE:

  • Advanced clinical/science degree required (PharmD, PhD, MSN, MPH, etc.)
  • Generally, 5 or more years pharma/biotech industry experience or demonstrates relevant equivalent clinical or

       laboratory research experience

  • Generally, at least 4 years experience with clinical trials
  • Experience authoring full clinical trial protocols and/or study results and conclusions
  • Experience with data visualization and interpretation
  • Experience with safety review and safety narratives
  • In-depth understanding of Phase I-II drug development
  • Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical
  • relevance
  • Comprehensive understanding of product and safety profiles
  • Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • Preferred: 2 or more years therapeutic area experience in oncology clinical trials (bone marrow transplant)

 

ABILITIES:

  • Proven abilities to perform CS responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of CS deliverables associated with assigned clinical studies
  • Outstanding attention to detail
  • Strong business acumen; has knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
  • Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance
  • Excellent written and verbal communication skills
  • Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points
  • Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end-results
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment.
  • Consistently and effectively identifies and addresses important factors affecting clinical trial design and execution

Why Kelly®?

Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

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.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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