Project Engineer
PerkinElmer
Job Level
Lead
About the role
- RQM+ is The MedTech CRO delivering regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies.
- We are seeking an experienced and strategic Director of Toxicology to lead our Toxicology team and deliver high-quality scientific services to clients.
- Responsible for overall performance, development, and direction of the Toxicology function with emphasis on operational excellence, client satisfaction, financial performance, and team leadership.
- Provide expert scientific and regulatory guidance on toxicology-related matters; review and approve toxicology protocols, reports, and client deliverables.
- Stay current on developments in toxicology, regulatory expectations, and emerging methodologies; provide strategic guidance on toxicology, risk assessment, and client engagement strategies.
- Lead initiatives to enhance team performance, process consistency, quality assurance, and continuous improvement; define and track KPIs.
- Collaborate with finance and leadership on budgets, resource allocation, pricing strategies, and monitor financial performance to meet revenue and margin goals.
- Serve as key client contact on toxicology projects; cultivate strong client relationships and support business development and proposal efforts.
- Lead, mentor, and develop the Toxicology team; oversee resource planning, workload balancing, performance management, talent acquisition, onboarding, and training.
Requirements
- Bachelor level degree in Toxicology, Pharmacology or related field.
- Advanced Degree preferred.
- Demonstrated 5 years technical/scientific writing experience in the medical device industry required.
- 7 years of regulatory or product development experience in the medical device industry preferred.
- Deep technical expertise in preclinical toxicology studies and regulatory expectations (e.g., GLP, FDA, OECD).
- Proven ability to manage teams, budgets, and complex projects in a dynamic, client-focused environment.
- Strong business acumen with experience in financial planning, budgeting, and strategic decision-making.
- Exceptional communication, leadership, and organizational skills.
- Experience with client engagement, proposal support, and delivering scientific presentations to external stakeholders
- Strong logic, and ability to understand and assimilate complex testing concepts.
- Establishes and maintains effective relationships with customers and gains their trust and respect.
- Experience working collaboratively with clients, peers, and cross-functional teams.
- High performance orientation, detail orientation, and strong organizational skills.
- Ability to problem-solve, think strategically, and respond appropriately to customer needs.
- Self-motivated individual with a “lead by example” approach that endorses the company’s values and culture.
- Strong commitment to professional and scientific integrity, compliance, and patient safety.
