Senior Managing Scientist

This is a fully remote position, open to applicants in Alabama, +17 more states.

📋 Description

• Tackle scientific, regulatory, and business challenges linked to pharmaceutical and biopharmaceutical product development.

• Supervise study placement, design, data interpretation, and monitoring of toxicology studies.

• Analyze safety, TK/PK, and PK/PD data.

• Act as the toxicology representative within project teams.

• Engage in discussions with global regulatory authorities.

• Author or oversee the pharmacology/toxicology sections of regulatory submission documents, such as pre-IND, IND/CTA, and NDA/BLA materials.

• Write or supervise expert opinion reports, waiver requests, presentations, and proposals.

• Take part in due diligence meetings for in- and out-licensing opportunities.

• Attend and present at toxicology conferences, serve on professional/scientific committees, and publish research papers or book chapters.

• Execute business development initiatives to attract and cultivate new projects and clients.

• Collaborate with toxicologists, epidemiologists, engineers, and biostatisticians.

• Travel may be necessary, up to roughly 20% of the time.

⛳️ Requirements

• Over 15 years of experience in biopharmaceutical or pharmaceutical sectors, including consulting and/or roles in industry, government (e.g., FDA), or Contract Research Organizations (CROs).

• Ph.D. in toxicology, pharmacology, or a closely related field.

• DABT certification is preferred but not mandatory.

• Previous experience in pharmaceutical consulting, the pharmaceutical industry, and/or government is essential (minimum of 15+ years).

• Extensive knowledge of ICH and regulatory agency guidance documents pertaining to nonclinical drug development.

• Proven experience collaborating with drug development teams and managing nonclinical safety assessment programs throughout all stages of development (e.g., from pre-IND to marketing).

• Background in conducting nonclinical gap analyses for drug development initiatives.

• Competence in drafting regulatory documents (e.g., pre-IND packages, INDs, BLAs/NDAs) and engaging with regulatory agencies.

• Experience in managing and addressing project-related toxicology and/or clinical-hold challenges.

• Project management skills, including the capacity to handle multiple tasks and maintain a balance with complex, high-priority programs and tight deadlines.

• Proven written and verbal communication abilities.

• Capacity to work autonomously or as part of multidisciplinary teams.

• Active membership and involvement in scientific and toxicology professional organizations, including recent presentations and/or publications.

🏝️ Benefits

• Opportunities for professional growth and leadership development.

• Competitive salary and benefits package.