Project Manager/Sr. Project Manager, Clinical Drug Supply
Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com.
Molecular Templates is seeking a highly-experienced and dynamic professional to lead efforts supporting clinical drug supply, management of clinical storage depots, and support of clinical drug labeling and release. This Manager will collaborate with manufacturing, quality, regulatory, clinical operations, and leadership teams to ensure a secure supply of clinical drug for all development programs. This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams and contractors.
Job Responsibilities may include:
- Manage clinical drug supply efforts and vendors related to clinical drug supply, storage, shipment, labeling, expiry, and supply/demand forecasting in conjunction with Quality, Regulatory, Clinical and Manufacturing
- Partner with Clinical Operations to identify demand assumptions and create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and programs
- Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
- Review clinical trial protocols and understand impact to supply
- Develop and obtain approval of project plans which define scope, timelines, deliverables, risk management plan, communication plan, and budget for projects related to ETB development
- Utilize project management tools and methods to effectively manage, monitor, and report projects
- Define and manage contracted and in-house development milestones and ensure completion of deliverables on-time and on-budget
- Prepare requests for proposal (RFPs) which describe, but are not limited to: project scope, deliverables, milestones, and responsibility matrix sufficient to obtain bids for contracted work
- Review contract bids and vendor qualifications based on costs, risks, timelines, quality audits, and deliverables and provide recommendation of specific contract group for project execution
- Manage projects conducted by contract groups or in-house with efficient governance including contract execution, authorization of change orders, schedule and budget variance management, progress reporting to stakeholders, review of data and reports, completion of contract milestones, managing project meeting agendas and action items, and alignment of clinical drug supply efforts with corporate drug development efforts and priorities
- Communicate project status and outcomes with upper management and other project stakeholders with optimal efficiency and accuracy
- Prepare and submit MTEM project documents, reports and summaries
- Execute and manage new projects and other duties, as assigned
- Advanced degree, required
- 7+ years of relevant experience, at least 3-5 years of experience specific to project management of products in clinical development, including efforts related to clinical drug supply, preferably for large molecule biopharmaceutical products
- Comprehensive understanding of clinical drug supply efforts related to global clinical trials
- Demonstrated knowledge of GMP/GCP US and EU regulations and regulations related to clinical drug supply
- Proven experience evaluating/selecting vendors and managing contract relationships, particularly CMO and CRO management, including labeling, packaging, and global clinical supply distribution
- Proven knowledge and experience in project management
- Proficiency with ERP or other materials management systems knowledge, preferred
- Experience participating on and leading cross-functional project teams
- Excellent problem-solving, data analysis and computational skills
- Excellent time management and multi-tasking skills
- Excellent written and verbal communication skills
- Proven ability to design projects independently
- Ability to function independently and exercise high-level of judgement
- Ability to multi-task and work in a fast-paced, team environment
- Requires up to 20% travel
This position currently has no supervisory responsibilities. This position reports to the Sr. Director, Biopharmaceutical Project Management.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.