Senior Managing Scientist

BlueRidge Life Sciences•Wyoming, MI

About The Position

The ToxStrategies division of BlueRidge Life Sciences is seeking an experienced toxicologist to join its expanding pharmaceutical toxicology consulting practice. The role provides scientific, strategic, and regulatory consulting to companies at all phases of drug development, with a focus on nonclinical safety assessment of biopharmaceutical and pharmaceutical products. The successful candidate will bring an in-depth understanding of drug development science and regulation across therapeutic indications, including current ICH and regulatory agency guidance, industry trends, and safety assessment study conduct. The position may involve designing and overseeing nonclinical safety assessment programs for drug candidates and interpreting and integrating data across studies for clients and regulatory authorities. It may also involve overseeing study protocols and reports, writing nonclinical sections of regulatory documents, and interacting with agencies such as the FDA, MHRA, and EMA. The scientist will work with multidisciplinary experts and may contribute to professional development, leadership, business development, publications, and scientific meetings. Travel may be required, up to approximately 20%.

Requirements

Ph.D. in toxicology, pharmacology, or a related science.
At least 15 years of experience in pharmaceutical consulting, the pharmaceutical industry, government (such as the FDA), or a combination of these.
Comprehensive understanding of ICH and regulatory agency guidance documents for nonclinical drug development.
Experience working with drug development teams and overseeing nonclinical safety assessment programs through all development phases, from pre-IND to marketing.
Experience performing nonclinical gap analyses for drug development programs.
Experience writing regulatory documents such as pre-IND packages, INDs, and BLAs/NDAs, and interacting with regulatory agencies.
Experience managing and resolving project-related issues and toxicology or clinical-hold issues.
Project management experience, including managing multiple assignments and balancing complex, high-priority programs with stringent timelines.
Demonstrated written and verbal communication skills.
Ability to work independently and in multidisciplinary teams.
Membership and active involvement in scientific or toxicology professional organizations, such as BioSafe, SOT, or ACT, including recent presentations and/or publications.

Nice To Haves

Diplomate of the American Board of Toxicology (DABT) certification.

Responsibilities

Address scientific, regulatory, and business challenges associated with pharmaceutical and biopharmaceutical product development.
Oversee study placement, design, data interpretation, and monitoring of toxicology studies; interpret safety, TK/PK, and PK/PD data.
Serve as the toxicology representative on project teams.
Participate in meetings with global regulatory authorities.
Write or oversee writing of pharmacology/toxicology sections of regulatory submissions, including pre-IND, IND/CTA, and NDA/BLA documents.
Write or oversee writing of expert opinion reports, waiver requests, presentations, proposals, and related materials.
Participate in due diligence meetings for in- and out-licensing.
Attend and present at toxicology meetings, serve on professional or scientific committees, and publish papers or book chapters.
Conduct business development activities to attract and develop new projects and clients.
Travel as required, up to approximately 20%.