Senior Pre-Clinical Pharmacology & Toxicology Scientist

Location
Bethesda, MD, US
Posted
Mar 25, 2021
Ref
2021-9978
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overview

We are currently searching for a Senior Pre-Clinical Pharmacology & Toxicology Scientist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.

Duties & Responsibilities

  • Provide recommendations on optimal non-clinical strategies to advance candidate products to the clinic.
  • Work closely with cross-functional groups to formulate non-clinical proof of concept and toxicology testing strategies prior to the start of any IND-enabling activities to ensure that the studies are meeting the program's needs and are designed to fulfil regulatory requirements.
  • Communicate regulatory information to multiple departments and ensuring that the information is interpreted correctly.
  • Successfully interact with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and explain those recommendations to Leadership.
  • Facilitate communication and collaboration internally and/or externally (i.e. vendors/CRO) to ensure mutual clarity amongst multidisciplinary teams and accuracy and suitability of documents/reports for regulatory submission.
  • Maintain current knowledge of relevant domestic and international regulations, including proposed final rules and guidance documents.
  • Review and approve toxicology protocols and reviewing non-clinical protocols for completeness and compliance with FDA current Good Laboratory Practice (GLP) and applicable regulations.
  • Develop and integrate timelines for non-clinical activities with overall program timelines and program goals, in close coordination with Program Management, CMC, Clinical, Regulatory groups and other stakeholders.
  • Work together with Regulatory personnel and subject matter experts to author relevant sections of regulatory submission documents (pre-IND and IND) as well as the nonclinical section of Investigator's Brochures.
  • Prepare and/or review all IND non-clinical reports, including toxicology reports from vendors/CRO for submission to the regulatory authorities.
  • Provide responses to regulatory agencies comments regarding non-clinical research or potential pre-IND and IND submission issues.
  • Collaborate with strategic planning group during contract negotiation to provide insight and guidance regarding scope of work pertaining to non-clinical/toxicology studies.
  • Oversee CROs and other external resources and ensure quality results are delivered. This includes study design, protocol development, coordination of study materials, data interpretation, report review and approval.
  • Develop and maintain SOPs, in collaboration with relevant subject matter experts, for non-clinical/toxicology studies, including their review and approval processes.



Requirements

  • Ph.D. in toxicology, biology/pharmacology, with at least 10 years related experience with vaccines and other biologics.
  • American Board of Toxicology (DABT) required.
  • Regulatory Affairs Certificate preferred.
  • Experience specifically supporting drug discovery research and development from a toxicology standpoint.
  • Experience in designing, conducting, monitoring and interpreting nonclinical toxicology/research studies.
  • Demonstrated success managing interactions with external CROs, consultants and other contract organizations is a plus.
  • Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.
  • Excellent organizational, interpersonal and verbal/written communication skills and ability to perform as an effective, flexible and self-assured team player.


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Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...
  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.


We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.