Director, Regulatory Affairs
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 regulatory functions and strategies company-wide, as well as interface with regulatory agencies. The Director will oversee and direct all regulatory activities for new and established products to ensure alignment and compliance with regulatory requirements, as well as with corporate policies and objectives. This requires effective leadership and managerial skills, strategic initiative and ability to collaborate with cross-functional teams, contractors and across regulatory sector.
Job Responsibilities will include:
- Direct strategic and operational management for all regulatory activities, including but not limited to: develop plans to meet corporate milestones, regulatory requirements for pre-clinical and clinical studies, conduct risk assessments, critical issue management, translate requirements into practical and efficient plans, and provide expert advice on regulatory matters.
- Compile, prepare and submit timely and scientifically-valid applications and investigational documentation to regulatory agencies, including INDs, CTAs, DMFs, BLAs, NDAs, MAAs, annual reports, protocol amendments, adverse event reports, notifications, and other reports.
- Interact with regulatory agencies related to all aspects of drug development, including resolution of critical issues and concerns, expedited approvals, and amendments
- Collaborate with internal and external stakeholders to build relationships that drive results towards meeting project deadlines and corporate milestones
- Maintain knowledge of regulatory environment and trends, while assessing impact on product development and corporate planning.
- Advanced degree in life sciences, law or regulatory science
- 10+ years biotechnology or pharmaceutical industry, with at least 5 years in regulatory leadership role
- Proven experience as lead in Regulatory Affairs related to oncology products
- Demonstrated experience in preparation, submission and negotiation of INDs, CTAs, DMFs, BLAs, NDAs, and MAAs for oncology products
- Must possess comprehensive scientific understanding while also possessing strong business acumen
- Excellent written and verbal communication skills
- Excellent computer skills
- Excellent project management skills
- Excellent analytical skills and problem-solving skills
- Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment
- Ability to work collaboratively with cross-functional teams and contractors in order to drive results and meet company objectives
- Ability to cultivate strong business relationships and liaise with industry partners and regulatory agencies
- Ability to function independently and exercise good judgement, as well as in a team-based environment
- Travel required 20-30%
This position currently has no supervisory responsibilities. This position reports to CMO, in absence to COO.
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.