Scientist, Clinical Research

Location
Gaithersburg, MD, US
Posted
Sep 25, 2020
Ref
670452400
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Scientist, Clinical Research requires knowledge and understanding of scientific concepts for clinical trial design and analysis, clinical development plans and clinical trial procedures in a cGCP environment. Primary responsibilities include scientific and technical contribution on projects and initiatives, key input into clinical development plans, clinical study design, data analysis and interpretation to support development activities. Additionally, the Scientist, Clinical Research coordinates with other clinical development team members to align development strategies, may represent the department when required, and may present scientific data internally and externally.

Responsibilities
  • Provides scientific expertise for clinical drug development from trial design to final study report for assigned projects and may represent the department on core teams.
  • Key contributor to the clinical development plans including design of clinical programs, concept sheets and proposals to support clinical development
  • Keeps current on scientific and medical literature in target therapeutic areas.
  • Appropriately designs studies to meet desired clinical endpoints and works with clinical development team to determine appropriate methods, procedures and measurements.
  • Works closely with Biostatisticians in designing studies and analysis of data, and with Medical lead to ensure medical input/oversight of study design and medical review of data during clinical trials and analysis. Ensures studies are designed appropriately for study conduct with Clinical Operations and collaborates with Data Management for appropriate data collection.
  • Contributor to the clinical sections of regulatory documents including IND and BLA/NDS, investigator's brochure, developmental safety update reports, clinical overview/summaries and product labeling/prescribing information; works with Medical Writing to execute on these deliverables, when necessary.
  • Meets measurable short- and long-term objectives for assigned clinical studies and appropriately escalates issues and changes in program goals and timelines.
  • Routinely makes project decisions with team input to resolve problems and assesses impact to clinical development program(s).
  • Develops collaborative relationships with other internal groups including Research & Development, Regulatory Affairs and corporate Project Management groups to ensure common goals are met.
  • Develops professional scientific and clinical development communications including presenting relevant clinical information internally to department(s), project teams and leadership teams.
  • Delivers internal clinical trial/program training and study/program updates, may represent Emergent externally at investigators meetings/study initiation visits, and at scientific conferences/meetings.
  • May present clinical plans, clinical study protocols and study results at regulatory meetings, for example FDA, Health Canada, EMA.
  • Interacts with scientific and medical experts and opinion leaders and study investigators regarding the development of clinical study protocols and programs.
  • May represent the department on core teams and present scientific data internally and externally.
  • Participates in development and continuous improvement of departmental processes and workflows.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
EDUCATION
  • Qualified candidates will have an advanced degree in Life Sciences (Ph.D. preferred) or Medicine.
  • EXPERIENCE
  • At least 2-5 years of experience as a Clinical Research Scientist or of related experience.
  • KNOWLEDGE, SKILLS & ABILITIES:
  • Excellent written and oral communication skills are required.
  • Excellent knowledge of Health Canada, FDA, other international regulations and ICH-GCP guidelines required.
  • Ability to communicate and present complex scientific and clinical issues to management and regulatory authorities.
  • Excellent computer skills, with ability to work within core templates designed for regulatory submissions, basic MS software, search engines for literature reviews, navigating regulatory websites.

ADDITIONAL REQUIREMENTS:
• Citizenship/Permanent Resident or Valid Work Permit.
• Successful Completion of a Criminal Record Check.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.