Project Manager – MSAT
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
Purpose of Job
The key purpose of this job is to develop, maintain and improve activities to enable a seamless and time efficient transition of preclinical programs into clinical studies. This role should aim to achieve clear alignment of activities within internal functional groups and with stakeholders at multiple seniority levels inside and outside of the company.
- Manage the timelines and coordination from pre-clinical research programmes into MSAT using standardized approaches from the receiving unit.
- Manage the timelines and coordination from MSAT programs to GMP programs using standardized approaches from the sending unit.
- Pre-empt and identify opportunities/risks to the MSAT pipeline and resource utilisation.
- Manage communication for third party testing and development labs for MSAT programs.
- Maintain project dashboards per therapeutic product
- Maintain alignment of ongoing and new programs with cross functional teams.
- Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken
- Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state
Key Performance Indicators
- 4 new product introductions from pre-clinical to GMP per annum
- Up to date visualization of development timelines and dependencies
- Optimized systems for transferring and tracking information and technology between parties
Key Job Competencies
- Experience with Project management methodologies (PMP/PRINCE2/Agile/SCRUM)
- Experience with project Gantt software
- Visualization of timelines and dependencies to different stakeholders
- Experience with AAV manufacturing workflows
- Experience with AAV analytics workflows
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Change Management – Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
- Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Oral Communication – speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- Demonstrated commitment to continuous improvement at the individual, department, and organizational levels.
- Experience with experimental design, with an understanding of process validation.
- Visualization of timelines per program and budget for external initiatives.
- Continuous optimization of systems and methodologies to manage product transition from pre-clinical to clinical manufacturing and release.
- Communication with global internal and external parties.
- MSc degree in biological discipline or equivalent is desired.
- BSc degree in biological discipline or equivalent and 2 years of academic/ biotech industry.
- Accredited PM qualification (PRINCE2/AgilePM/PMP) desirable but not essential.