Senior Director Nonclinical Development
Viatris
4 hours ago
Remote friendly (United States)
United States
$151,000 - $314,000 USD yearly
Clinical Research and Development
Key responsibilities:
- Direct all aspects of nonclinical development, including staffing, supervising, providing work direction, goal setting, prioritization, etc.
- Oversee development of the nonclinical regulatory strategy, design of experiments, interpretation of data, and oral/written presentation of results.
- Oversee review and approval of preclinical protocols and final reports for nonclinical development studies; ensure data quality and integrity for preclinical sites.
- Communicate preclinical findings to project teams, senior management, regulators, and external partners.
- Oversee research and construction of regulatory study documents for new/complex product development (e.g., IND/NDA preclinical sections).
- Represent Viatris and Global Pharmacology and Toxicology in meetings with regulatory agencies.
- Provide technical support to internal departments regarding pharmacology and toxicology.
- Serve as a reviewer on toxicological risk assessments for various health based exposure limits (HBELs) such as ADEs, PDEs, ADIs, and OELs.
- Assist with development and adherence to departmental budget.
- Review for comprehension relevant Standard Operational Procedures (SOPs).
Minimum qualifications:
- Bachelor’s degree (or equivalent) and 15 years of experience. DVM/PhD or biomedical discipline or PharmD preferred with 10 years of relevant pharmaceutical experience preferred (equivalent combinations considered).
- Expert knowledge of pharmaceutical drug development requirements for regulatory submissions.
- Expert in-depth knowledge of product development, analytical sciences, and clinical operations.
- Broad knowledge of GMP, GLP, GCP, and global regulatory process for brand/specialty and generic approvals.
- Team-oriented; exceptional organizational, oral/written communication, and computer skills.
- Ability to interface with diverse stakeholders and provide guidance/recommendations to R&D, Regulatory, and Business Development teams.
- Autonomously functions; directly supervises employees (e.g., hiring, training, assigning work, performance appraisal).
- Ability to read/interpret complex research documents; write scientific reports/technical correspondence; communicate with executives; present to internal and external groups.
- Ability to solve complex problems using independent judgment and analysis.
- Ability to perform typical office work; intermittent sitting/standing/walking and periodic travel may be required.
- Proficiency in speaking, comprehending, reading, and writing English required.
Compensation:
- Salary range: $151,000 - $314,000.
- Direct all aspects of nonclinical development, including staffing, supervising, providing work direction, goal setting, prioritization, etc.
- Oversee development of the nonclinical regulatory strategy, design of experiments, interpretation of data, and oral/written presentation of results.
- Oversee review and approval of preclinical protocols and final reports for nonclinical development studies; ensure data quality and integrity for preclinical sites.
- Communicate preclinical findings to project teams, senior management, regulators, and external partners.
- Oversee research and construction of regulatory study documents for new/complex product development (e.g., IND/NDA preclinical sections).
- Represent Viatris and Global Pharmacology and Toxicology in meetings with regulatory agencies.
- Provide technical support to internal departments regarding pharmacology and toxicology.
- Serve as a reviewer on toxicological risk assessments for various health based exposure limits (HBELs) such as ADEs, PDEs, ADIs, and OELs.
- Assist with development and adherence to departmental budget.
- Review for comprehension relevant Standard Operational Procedures (SOPs).
Minimum qualifications:
- Bachelor’s degree (or equivalent) and 15 years of experience. DVM/PhD or biomedical discipline or PharmD preferred with 10 years of relevant pharmaceutical experience preferred (equivalent combinations considered).
- Expert knowledge of pharmaceutical drug development requirements for regulatory submissions.
- Expert in-depth knowledge of product development, analytical sciences, and clinical operations.
- Broad knowledge of GMP, GLP, GCP, and global regulatory process for brand/specialty and generic approvals.
- Team-oriented; exceptional organizational, oral/written communication, and computer skills.
- Ability to interface with diverse stakeholders and provide guidance/recommendations to R&D, Regulatory, and Business Development teams.
- Autonomously functions; directly supervises employees (e.g., hiring, training, assigning work, performance appraisal).
- Ability to read/interpret complex research documents; write scientific reports/technical correspondence; communicate with executives; present to internal and external groups.
- Ability to solve complex problems using independent judgment and analysis.
- Ability to perform typical office work; intermittent sitting/standing/walking and periodic travel may be required.
- Proficiency in speaking, comprehending, reading, and writing English required.
Compensation:
- Salary range: $151,000 - $314,000.