Scientist, Clinical Research

Location
Gaithersburg, MD, US
Posted
Oct 12, 2020
Ref
627682100
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.

Job Summary

The Senior Scientist, Clinical Research is responsible for
i) providing scientific expertise and clinical strategy to assigned clinical development programs to other Clinical Research groups (eg, clinical operations, biostatistics, data management) or to internal company departments (eg, pre-clinical, bioanalytical, medical writing, regulatory affairs);
ii) authoring relevant clinical trial documents; and
iii) playing a key role in the clinical development of the assigned product and the associated regulatory submission process. Additionally, the Senior Scientist provides leadership by acting as a mentor to clinical research scientists and/or colleagues in Clinical Research department.

This position is located in Gaithersburg, MD.

Essential Functions
  • Leads clinical research studies from trial design to final study report for assigned projects.
  • Develops, prioritizes and meets measurable short- and long-term objectives for assigned clinical studies.
  • Provides guidance to relevant Clinical Research groups (eg, clinical operations, biostatistics, data management) involved in design and conduct of clinical studies.
  • Authors/reviews clinical trial protocols, investigator's brochure, clinical study reports, clinical sections of regulatory submission documents including IND and BLA/NDS, developmental safety update reports, clinical overviews/summaries, clinical assessments.
  • Appropriately designs studies to meet desired clinical endpoints and with appropriate methods and measurements.
  • Reviews and applies current company SOPs. Revises relevant SOPs, when required.
  • Tracks progress of assigned clinical development programs and addresses problems as necessary
  • Collaborates with other internal departments including Pre-clinical, Bioanalytical, Medical Writing, Regulatory Affairs, Pharmacovigilance and corporate project management groups to ensure common goals are met.
  • Provides leadership/mentorship to clinical research scientists or to colleagues in other Clinical Research groups (eg, clinical operations, biostatistics, data management).
  • Presents internally for clinical trial/program training; externally (when required) to investigators/clinical trial site personnel (eg, site initiation visit, investigator meeting), data safety monitoring boards (DSMBs), at regulatory agency meetings, conferences and/or advisory boards.
  • Attends and contributes at regulatory meetings with FDA, Health Canada, EMA.
  • Manages relationships with clinical consultants and/or relevant clinical research organization (CRO) personnel.

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 one of the following:
    • An advanced degree in Life Sciences or Medicine (PhD, PharmD or MD preferred) with at least 4 years of experience with a pharmaceutical company, CRO or other relevant clinical research institutions;
    • A Master's degree in Life Sciences with at least 5 years of experience with a pharmaceutical company, CRO or other relevant clinical research institutions;
    • A Bachelor's degree in Life Sciences with at least 6 years of experience with a pharmaceutical company, CRO or other relevant clinical research institutions.

EXPERIENCE:
  • Must have knowledge and understanding of Health Canada, FDA and ICH regulatory requirements and procedures applicable to Clinical Research and Product Development.
  • At least 4 years of experience in the pharmaceutical industry with direct experience in designing and managing clinical studies.
  • Previous experience working in a matrix environment is highly desirable. Experience in clinical operations, biostatistics or data management is an asset.


KNOWLEDGE, SKILLS & ABILITIES:
  • Ability to drive efforts, overcome obstacles and achieves results within budget and timeline specifications.
  • Experience in presentations in public or regulatory settings. Excellent organizational, analytical, leadership, problem solving and interaction skills.
  • Ability to work in a highly diverse and fast paced, team environment.
  • Excellent written/verbal communication and interpersonal skills, as well as excellent computer skills required.

ADDITIONAL REQUIREMENTS:
  • Successful Completion of a Criminal Record Check.


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.