Director/Sr. Director of Biopharmaceutical Project Management
Molecular Templates (MTEM) is a clinical stage biopharmaceutical company focused on the development of a next generation immunotoxin platform technology called Engineered Toxin Bodies (ETB) in oncology. MTEM’s lead program, MT-3724, is in clinical development for non-Hodgkin’s lymphoma and additional pipeline drug candidates are being advanced toward clinical development for a variety of cancers. For more information, please visit MTEM’s website at www.mtem.com.
Molecular Templates is seeking a highly-skilled and highly-motivated professional to lead project management efforts related to biopharmaceutical development. The Director/Senior Director of Biopharmaceutical Project Management will be responsible for managing projects related to ETB manufacturing and testing which support the preclinical and clinical development of ETBs. Additionally, this position will develop and manage project management tools and procedures to effectively manage, monitor, and report projects. This position will also be responsible for identifying and managing outsourced efforts conducted at contract research organizations (CROs) and contract development and manufacturing organizations (CDMO). Qualified candidates will possess excellent project management, time management, communication, data analysis, and interpersonal skills, along with an overall understanding of and experience in early-stage development within the biopharmaceutical industry.
Job Responsibilities may include:
- 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
- Develop 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 actions items, and alignment of biopharmaceutical development efforts with corporate drug development efforts and priorities
- Efficiently and accurately communicate project status and outcomes with upper management and other project stakeholders
- Prepare and submit MTEM project documents, reports and summaries
- Manage projects related to biopharmaceutical development not limited to: product manufacturing, process development, product quality control and stability testing, clinical bioanalytical method testing, facility management, clinical sample management, and regulatory document submission
- Execute and manage new projects and other duties, as assigned
- An advanced degree with 10+ years of relevant experience, at least 5-7 years of experience specific to project management of preclinical/translational development, preferably for large molecule biopharmaceutical products
- Comprehensive understanding of biopharmaceutical product development and stages of drug discovery
- Proven knowledge and experience in project management, project management certification is required
- Demonstrated knowledge of GMP regulations related to biopharmaceutical product manufacturing and testing
- Experience participating on and leading cross functional project teams
- Proven experience selecting and managing contract relationships
- 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 and provide thought-leadership to project management
- Ability to function independently and exercise high-level of judgement
- Ability to later grow team and supervise direct reports, upon management approval and company need
- Ability to work in a fast-paced, team environment
- Requires up to 20% travel
This position has no supervisory responsibilities at this time. This position reports to the EVP of Operations & Head of Manufacturing.
Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.