Senior Managing Scientist

BlueRidge Life Sciences; Lorida (FL); Vor Ort; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

BlueRidge Life Sciences’ ToxStrategies division seeks an experienced toxicologist with 15+ years of biopharmaceutical/pharmaceutical experience to join our expanding toxicology consulting practice. The role involves leading nonclinical safety programs, interpreting cross-study data, and authoring regulatory sections for submissions while collaborating with cross-functional teams.

Travel up to ~20% may be required. A Ph.D.

Qualifikationen

• Ph.D. in toxicology required; DABT certification desired but not required.
• Minimum 15+ years of pharmaceutical/biopharmaceutical experience in consulting and/or industry or government roles.
• Strong understanding of ICH and regulatory guidance for nonclinical drug development.
• Experience leading nonclinical safety programs and data integration across studies.
• Experience writing regulatory documents and interacting with regulatory agencies.

Aufgaben

• Oversee nonclinical safety assessment programs for drug candidates.
• Interpret safety, TK/PK, and PK/PD data across studies.
• Lead writing of pharmacology/toxicology sections of regulatory submissions.
• Interact with regulatory agencies and participate in due diligence meetings.
• Coordinate study protocols, reports, and expert opinion documents.

Kenntnisse

Regulatory knowledge

Project management

Scientific writing

Team leadership

Cross-functional collaboration

Ausbildung

Ph.D. in Toxicology

Jobbeschreibung

We offer integrated, comprehensive solutions that address complex technical, clinical development, and safety and regulatory challenges, leveraging our deep scientific, medical, and regulatory expertise and real-world experience. Our goal is to help you complete projects efficiently and with less risk, leading to solutions for a healthier and safer world.

With a broad range of renowned scientific, medical, regulatory, and engineering specialists under one roof, we streamline your project and reduce your workload, so you can make sound, science-based decisions about human and environmental health issues.

BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting. Across these specialized areas, we collaborate to deliver science-driven solutions that support industries including pharmaceuticals, biotechnology, medical devices, chemicals, foods and consumer products. Our collective expertise helps clients navigate regulatory requirements, assess safety and efficacy, manage risks, and optimize pharmaceutical commercialization strategies.

If you’re ready to achieve your life science goals, there’s no better partner than BlueRidge Life Sciences.

Job Description:

The ToxStrategies division of BlueRidge Life Sciences is seeking an experienced toxicologist (15+ years biopharmaceutical/pharmaceutical experience, in consulting and/or industry, government [e.g., FDA] or Contract Research Organizations [CROs]), to join our expanding Pharmaceutical toxicology consulting practice.

ToxStrategies is a multidisciplinary consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. Scientists in our Pharmaceutical Practice provide consulting services to companies in all phases of drug development. This includes providing clients with scientific, strategic, and regulatory expertise in the nonclinical safety assessment of biopharmaceutical and pharmaceutical products. This position requires an in-depth understanding of the scientific and regulatory process for developing drug products to address a variety of therapeutic indications. The candidate must be familiar with current ICH and regulatory agency guidelines for drug development, industry trends, and conduct of safety assessment studies.

This 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. Additional responsibilities may include overseeing development of study protocols and reports, writing nonclinical sections of regulatory documents (e.g., pre-IND packages, IND/CTAs, BLAs/NDAs, Investigator Brochures), and interacting with regulatory agencies (e.g., FDA, MHRA, EMA). Within ToxStrategies, you will work alongside toxicologists, epidemiologists, engineers, and biostatisticians who are recognized as leaders in their respective fields. This position offers a stimulating and challenging work environment, opportunities for professional development and leadership, and competitive compensation and benefits.

Responsibilities May Include:

• Address scientific, regulatory, and business challenges associated with development of pharmaceutical/biopharmaceutical products
• Oversee study placement, design, data interpretation, and monitoring of toxicology studies, and 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 the pharmacology/toxicology sections of regulatory submission documents (e.g., pre-IND, IND/CTA, and NDA/BLA)
• Write or oversee writing of expert opinion reports, waiver requests, presentations, proposals, etc.
• Participate in due diligence meetings for in- and out-licensing
• Attend and present at toxicology meetings (e.g., ACT, SOT), serve on professional/scientific committees, and publish (papers, book chapters)
• Conduct business development activities to attract and develop new projects/clients
• Travel may be required (up to approximately 20%)

Essential Qualifications:

• Ph.D. degree in toxicology, pharmacology, or related sciences; DABT certification is desired but not required
• Prior pharmaceutical consulting and/or pharmaceutical industry and/or government experience (e.g., FDA) 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 the demands of overseeing complex, high-priority programs and stringent timelines
• Demonstrated written and verbal communication skills
• Ability to work independently or in multidisciplinary teams
• Member of and actively involved in scientific/toxicology professional organizations (e.g., BioSafe, SOT, ACT), including recent presentations and/or publications