Senior Managing Scientist

Job not on LinkedIn

🔥 13 hours ago

🏈 Alabama, Alaska, +16 more states – Remote

🏈 Alabama – Remote 🐻 Alaska – Remote 🏄 California – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote 🤠 Texas – Remote ⛷️ Utah – Remote ⚔️ Virginia – Remote ⛰️ West Virginia – Remote 🦬 Wyoming – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ToxStrategies, a BlueRidge Life Sciences Company

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💼 Consulting

🏥 Healthcare

🍽️ Food & Beverage

💰 Venture Round - ToxStrategies on 2023-01

Consulting • Healthcare • Food & Beverage

ToxStrategies is a multidisciplinary scientific consulting firm and BlueRidge Life Sciences company that provides toxicology, environmental, and regulatory science services to industry, government, and legal clients. The firm offers expertise in risk assessment, exposure assessment, computational toxicology, bioavailability, PFAS, micro- and nanoplastics, food and pharmaceutical safety, medical devices, NAMs, epidemiology, and regulatory compliance (e. g. , TSCA, FSMA, Proposition 65). ToxStrategies supports product stewardship, litigation support, and evidence-based toxicology across consumer products, chemicals, and biopharmaceutical contexts.

📋 Description

• Address scientific, regulatory, and business challenges associated with pharmaceutical/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 pharmacology/toxicology sections of regulatory submission documents, including pre-IND, IND/CTA, and NDA/BLA documents • Write or oversee expert opinion reports, waiver requests, presentations, and proposals • Participate in due diligence meetings for in- and out-licensing • Attend and present at toxicology meetings, serve on professional/scientific committees, and publish papers or book chapters • Conduct business development activities to attract and develop new projects and clients • Work alongside toxicologists, epidemiologists, engineers, and biostatisticians • Travel may be required, up to approximately 20%

🎯 Requirements

• 15+ years of biopharmaceutical/pharmaceutical experience in consulting and/or industry, government (e.g., FDA), or Contract Research Organizations (CROs) • Ph.D. degree in toxicology, pharmacology, or related sciences • DABT certification desired but not required • Prior pharmaceutical consulting and/or pharmaceutical industry and/or government experience required (minimum 15+ years) • 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 (e.g., pre-IND to marketing) • Experience performing nonclinical gap analyses for drug development programs • Experience writing regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs), and interacting with regulatory agencies • Experience managing and resolving project-related and toxicology and/or clinical-hold issues • Project management experience, including the ability to manage multiple assignments and balance complex, high-priority programs and stringent timelines • Demonstrated written and verbal communication skills • Ability to work independently or in multidisciplinary teams • Membership and active involvement in scientific/toxicology professional organizations, including recent presentations and/or publications

🏖️ Benefits

• Opportunities for professional development and leadership • Competitive compensation and benefits