We are seeking a dynamic and strategic Associate Director, Process Management to create and drive business process optimization and continuous improvement in support of the growth and organizational effectiveness of our Clinical Research & Development team. This role requires a minimum of 3 days a week of onsite presence in either our California or New Jersey offices.
About You:
The ideal candidate is a collaborative and dynamic individual with a strong background in developing and executing robust business processes to improve efficiency, optimize resources, and reduce errors and compliance risks. You have experience engaging and organizing subject matter experts and cross-functional groups to identify gaps and inefficiencies and taking action to bridge these gaps through process optimization. Additionally, you have a strong background in the end-to-end clinical drug development process.
Key Responsibilities:
- Lead project teams in creating, reviewing, and maintaining procedural documents (e.g., SOPs, policies, job aids), process maps, and personnel qualification strategies.
- Partner with Business Process Owners to ensure processes integrate with the end-to-end clinical drug development process, delivering efficiencies and mitigating compliance risks.
- Identify gaps and inefficiencies in current business processes and opportunities for improvement.
- Implement tools to collect and measure relevant data, identify key performance indicators (KPIs), and produce data-driven analyses of critical functions.
- Define and evaluate metrics to monitor the effectiveness of existing business processes.
- Collaborate with Business Process Owners and IT System Owners in the design, implementation, and release management of clinical systems (e.g., Clinical Trial Management System, electronic Trial Master File).
- Work with functional leaders, SMEs, and Clinical Quality Assurance to define compliance and business requirements, prioritizing core business processes based on strategic importance, regulatory requirements, and business impact.
- Develop and implement strategies to ensure ongoing inspection readiness for clinical trials.
- Support GCP audits and inspections by regulatory authorities and business partners.
- Develop and deliver training programs for new/updated operational procedures or clinical systems, including documentation, tools, and training to support adoption.
- Stay informed about changes in regulations, industry standards, and best practices.
Qualifications:
- 10+ years of clinical drug development experience with a Bachelor's degree or 8+ years with a postgraduate degree.
- Experience in the biotechnology or pharmaceutical industry is required.
- In-depth knowledge of ICH-GCP, EMEA guidelines, and other relevant regulations and guidelines.
- Demonstrated ability to lead and influence change in process development and system implementation.
- Ability to collaborate effectively with cross-functional teams and subject matter experts.
- Proven ability to synthesize information from multiple sources and make risk-based decisions.
- Experience with Veeva Quality Vault and Veeva Clinical Platform is preferred.
- Excellent written, organizational, and interpersonal skills.
- Ability to work onsite at least 3 days a week.
Compensation and Benefits:
At Biopharmaceutical Company, employee compensation includes bonus and equity compensation, along with several generous benefit programs, including:
- 401k plan with company matching
- Medical (premiums covered by Biopharma company at 95%), dental, and vision insurance (premiums covered by Biopharma company at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Biopharma company at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
Join Biopharma company and be part of a team dedicated to advancing clinical research and development through innovative process management!
