The Molecular Strategy Dir will be responsible for the operational and strategic oversight of all aspects of molecular data generation and analysis at M2Gen. This responsibility will encompass the entire data life cycle including oversight of ORIEN Members' clinical/laboratory protocols required for procurement of tissue specimens, supervision of operations of M2Gen's partner sequencing laboratories, and collaboration with M2Gen IT and Bioinformatics groups for analysis and storage of data. The director will also serve as a subject matter expert on regulatory, compliance and operations including CAP, CLIA, HIPAA and others.
· The Director will gather information and requirements from ORIEN Members, pharmaceutical partners and other sources and translate this into an operational strategy for M2Gen. Expertise and experience working with oncology NGS data is a must in order to proactively identify and troubleshoot potential problems, work with internal and external collaborators on solutions, and serve as a central point of communication for all. The Director will also gather information and requirements from ORIEN Members and pharmaceutical partners.
· The role will work cross-functionally across M2Gen's ORIEN team, M2Gen IT, and M2Gen bioinformatics to ensure that M2Gen is producing molecular data at a standard that meets its quality and quantity objectives.
· The Director will also serve as a subject matter expert to guide M2Gen's molecular data strategy. The Director will remain informed on ongoing trends and emerging technologies which may enhance M2Gen's capabilities and improve its solutions.
· Some travel will be required for visits to M2Gen's pharmaceutical partners, ORIEN Members, partner labs and trade conferences.
Key Duties and Responsibilities:
· Communicate with ORIEN Member cancer centers for sample handling and shipment protocols, process, etc.
· Provide oversight of NGS partner labs to ensure high quality, timely data delivery
· Collaborate with M2Gen IT and Bioinformatics teams to streamline analysis and delivery of data
· Serve as subject matter expert for M2Gen's molecular data strategy.
The Ideal Candidate will have:
· Familiarity with NGS data and related technologies
· Strong working knowledge of CAP, CLIA, HIPAA, Common Rule and other key relevant regulation
· Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data standards
· Working knowledge of global regulatory requirements regarding data standards
· Exceptional communication skills both written and verbal
· Impeccable ethics
· Demonstrated ability to work in fast-paced deadline-driven environment
· Ability to work independently and as part of a team
Experience & Education Requirement:
· Master's Degree in molecular biology, biochemistry or related field, Ph.D. preferred
· Minimum eight (8) years working in biology research setting