Senior Clinical Scientist

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Essential Functions:

  • Providing clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management.
  • Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
  • Collaborates with external opinion leaders and Principal Investigators and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
  • Works with study and program teams to achieve program goals and provides deliverables in approved timeframes.
  • Applies best regulatory practices and drug development precedent to assigned programs.
  • Supports the development of regulatory documents for filings and agency meetings
  • Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
  • Proactive identification of issues/problems and recommends solutions
  • Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
  • Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
  • Maintains knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing
  • Key point person with the clinical sites, CRO and medical monitor on the execution of the clinical trials; data delivery; data cleaning activities; and data interpretation
  • Quality data generation
  • Partner with data management and study medical monitor/director for CRF design, instructions, data review plan and conduct frequent clinical data listing review
  • Partner with biostatistics and study medical monitor/director for statistical analysis plan review and finalization
  • In conjunction with study medical monitor create and/or review slides for internal and external meetings such as investigator meetings, SIVs, company-wide meetings
  • Participate in long-term clinical development and planning a pathway to regulatory registration for assigned therapeutic area(s)
  • Serve as clinical science representative on cross-function teams as assigned
  • Author or contribute to production of high-quality documents or sections thereof that are scientifically sound
  • Oversees clinical study reports, protocols and amendments
  • Responsible for Investigator brochure, and other publications including abstracts and presentations
  • Prepares documents to support health authority interactions
  • Support development of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support development of stratification biomarkers.

Nature and Scope:

The job encounters problems of broad scope and moderate to high complexity with variations from the norm. The incumbent typically determines own practices and procedures and leads and/or contributes to the development of new concepts and programs. Errors in work would cause delays and financial loss.

Education:

Bachelor’s degree required, advanced science degree (PhD, PharmD, MS) strongly preferred

Experience:

  • 2+ years of drug development experience in academia and/or the Biopharmaceutical industry required
  • Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data
  • Advanced technology skills with the ability to work with large databases
  • Availability to participate in early or late meetings/teleconferences
  • Ability to manage priorities and competing demands in a changing work environment
  • Strong oral & written scientific communications skills
  • Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings)
  • Ability to strike proper balance between independent work and team interaction; good team player in a cross functional team

Working Conditions:

Works in an office environment.  Able to travel up to 20% internationally and domestically. May on a continuous basis walk, bend and lift up to 20 lbs.  The noise level in the work environment is usually low.  May intermittently sit at desk for a long period of time to answer telephone and write or use a keyboard to communicate through written means.  Must be flexible to work varying schedules and hours as needed and travel. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Equal Opportunity Employer/Females/Minorities/Veterans/Disability

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