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Company: PPD
Location: Wilmington
Posted on: June 24, 2022

Job Description:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose to improve health!About the Position:
The Clinical Scientist is responsible for providing input into and, at times, coordinating input for clinical consulting request for proposals (RFPs) and awarded consulting deliverables. The clinical scientist will also support the clinical trial RFP process and partnering with a feasibility and study operations lead through medical and data analysis to summarize the epidemiology, standard of care and competitive environment for the given opportunity.Current opportunities open for coverage in Respiratory and General Medicine Therapeutic Areas.About our Culture, Career Advancement and Benefits:
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well-being of our employees.Job Description:
Strong teamwork skills required to work with a cross-functional consulting team (experts in regulatory strategy, product development, biostatistics and pharmacokinetics). In addition, this role will be involved in projects in partnership with clinical scientists who will provide additional training and guidance. This is considered a subject matter expert level clinical scientist role, with client-facing responsibilities, including:

  • Developing, designing and optimizing protocol synopses and full protocols
  • Creating clinical development plans and strategic program assessments
  • Assisting in coordination of key opinion leader advisory boards
  • Conducting feasibility assessments
  • Providing competitive intelligence support for the PPD RFP process
  • Providing clinical strategy into health authority briefing packages
  • IND and NDA/BLA submission support
  • Other global regulatory submissions as needed#LI-CG1#LI-Remote#PPDHPJob QualificationEducation and Experience:
    • Seeking professional with exceptional client facing skills with a background in respiratory diseases and general/internal medicine (including women's health). PharmD, PhD or MD in a scientific discipline or related field required (clinical training and/or experience strongly preferred).
    • 4-6 + years of experience (post receipt of doctoral degree) working in the biotech/pharmaceutical industry required.

      Knowledge, Skills and Abilities:
      • Familiarity with the conduct of global clinical trials
      • Knowledge of GCP/IHC and FDA guidelines
      • Excellent interpersonal and communication skills
      • Strong attention to detail
      • Good organizational, prioritization and time management skills
      • Ability to work on multiple projects simultaneously
      • General familiarity with biostatistics and pharmacokinetics
      • Expert in navigating scientific literature, interpretation of data and display of data
      • Ability to work both independently and in a team environment
      • Highly proficient in standard computer software (MS Word, Excel, PowerPoint)PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
        • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
        • Able to work upright and stationary for typical working hours.
        • Able to use and learn standard office equipment and technology with proficiency.
        • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
        • This role requires independent travel up to 15%, inclusive of traveling in automobiles, airplanes, and trains.Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.COVID-19 Vaccination Update for U.S. Colleagues
          • All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.
            • All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.

Keywords: PPD, Wilmington , CLINICAL SCIENTIST - RESPIRATORY/GEN MED, Healthcare , Wilmington, North Carolina

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