June 2019, Vertex announced the establishment of a new research
site in the Boston area where research, development, and clinical
manufacturing for cell and genetic therapies will be primarily
based. Cell and genetic therapies represent two rapidly emerging
therapeutic modalities with the potential to treat—and even
cure—several of the diseases Vertex is focused on, including sickle
cell disease, Duchenne muscular dystrophy and type 1 diabetes.
Further investment in a research site specifically designed to
advance these programs will be key to Vertex’s continued and
sustained leadership in these exciting approaches. At Vertex Cell
and Genetic Therapies (VCGT) our research teams will bring together
the best biology, technologies and enhanced manufacturing
capabilities to ensure we bring these cutting-edge transformative
therapies to patients as quickly as possible.
VCGT is looking for an Associate Director Technical Project
Leader to join its growing team. The role will be responsible for
managing the technical development plan and CMC department
interfaces (internal and external) as part of the CMC Program
Management team. The AD Technical Project Leader will work closely
with the Cell, CMC, Clinical, Preclinical, and Quality teams to
meet program milestones. The position will be based in Boston, MA
or Cambridge, MA.
Independently leads sub-teams for critical development
Strategically develops plans, budgets, goals, and logistics for
projects, gaining cooperation and consensus
Work independently and with the team to develop a
cross-functional development plan from current stage through
Regularly interacts with functional areas beyond CMC, such as
Regulatory, Quality, Supply Chain, Technical Operations and
Manage the execution of deliverables, both short and long-term,
via clearly defined milestones, and timelines. Minimize timeline
deviations by clearly identifying program risks and communication
Build and sustain robust business processes to support
cross-functional clinical trial execution.
Proactively communicate key issues and any other critical topics
in a timely manner to the appropriate management level and/or to
any other relevant project team member(s).
Facilitate regular project team meetings, issue written minutes,
and follow up on action items.
Maintain overall project dashboard, schedule, budget, project
plans, operational plans, and routine reports to sponsors and
Represent company to external partners groups as required
B.S./M.S./Ph.D. with 8 plus years of relevant
biotech/pharmaceutical development or project management work
2+ years of demonstrated project management and change
management experience in a clinical pharma/biotech setting.
Experience in either preclinical or early clinical phase company
with hands on experience in GXP environment.
Strong interpersonal skills to elicit, synthesize, and manage
the cross-functional inputs required for a robust development
Ability to communicate effectively with a diverse range of
scientists, physicians, engineers, regulatory specialists and
Entrepreneurial spirit with a team attitude, demonstrated
leadership skills and an ability to integrate across all company
Experience in cell or gene therapy products.
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