Director Project Manager
Proclinical is currently recruiting for a Director Project Manager with an international pharmaceutical company located in Woburn, MA. Successful candidate will interact with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to complete pre-clinical, IND-enabling and Phase I activities.
- Manage vendor contracting including MSAs, work orders, and invoices.
- Prepare Request for proposals (RFPs) and detailed itemized proposal comparison.
- Ensure vendors stay on-task and complete contracted work in timely manner through weekly conference calls.
- Integrate deliverables and dependencies between vendors seamlessly.
- Conduct and coordinate review of technical documents and reports from manufacturing, toxicology, and other activities. Maintain a productive and professional relationship with vendors to ensure quality and maximize efficiency.
- Generate weekly status reports for all on-going activities.
- Prevent slippage from aggressive development timelines.
- Develop contingency plans to quickly and efficiently adapt to challenges that may arise.
- Provide strategies to reduce technical and logistical risks. Identify root causes of issues to prevent in future projects.
- Work independently and collaboratively in a matrixed environment.
- Keep detailed records of key activities, data, and reports in central repository in compliance with company archiving policies or as directed by the company leadership team.
- Maintain organization of central repository.
- Ensure necessary personnel have access required documents.
Skills and Requirements:
- 5+ years of industry experience in therapeutics or drug development.
- Demonstrated relevant experience in CMC and GLP toxicity activities and projects.
- Passion for teamwork, immense energy, absolute integrity, and an A+ attitude.
- Organized with ability to multi-task.
- Critical thinking, decision-making, and problem solving.
- Budgeting, from both a time and cost perspective.
- Knowledge of toxicology, preclinical development, medicinal chemistry practices, regulatory guidelines and stages of drug development.
- Experience in IND submissions.
- General knowledge of oncology and CNS disorders.
- Experience in contract management.
- Attention to detail.
- Robust initiative.
- Capacity to foster a fast-paced, yet supportive, working environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.