Medical Director/Senior Medical Director, Early Clinical Development
Company: Century Therapeutics, Inc
Posted on: January 15, 2022
Position Title: Medical Director or Senior Medical Director,
Early Clinical DevelopmentReports to: Nikolaus Trede, MD, PhD
Company Background:Century Therapeutics is developing novel
allogeneic living cell products for oncology that overcome the
limitations of current cell therapies. Century's
genetically-engineered, universal iPSC-derived immune effector cell
products are designed to specifically target hematologic and solid
tumor cancers. Our commitment to developing off-the-shelf cell
therapies will expand patient access and provide an unparalleled
opportunity to advance the course of cancer care.
Century's foundational technology is built on induced pluripotent
stem cells (iPSCs) that have unlimited self-renewing capacity. This
enables complex cellular engineering to produce controlled cell
banks of modified cells that can be expanded and differentiated
into desired immune effector cells, which can supply vast amounts
of allogeneic, homogeneous therapeutic products. This platform
differentiates Century from other approaches that utilize
non-renewable donor-derived cells.
Role:The successful candidate will report to the Early Clinical
Development Lead to serve as the primary source of clinical
oversight of one or more early phase clinical trials.
Clinical Trial Oversight:
- Provide medical guidance to investigators on managing patients
on clinical protocols.
- Oversee and assess clinical data and safety narratives.
- Provide medical and scientific expertise to study teams and key
- Oversee quality, coordination and timeliness of clinical
sections of INDs, Investigator Brochures, CSRs and clinical expert
- Build investigator relationships for multiple hematologic
malignancy indications and protocols.
Interaction with Health Authorities:
- Drive clinical trial protocol development and execution through
- Provide clinical leadership to allow for initiation of US and
global trials in collaboration with regulatory and clinical
operations team members.
- Interact seamlessly with biomarker translational scientists to
inform and refine clinical product development and strategy.
- Engage and inspire the project/clinical development team
through communicating the strategic vision and the operational plan
to achieve team and company goals.
- Participate in the development of the clinical strategic plan
for product/therapy area.
- Prepare, present and manage materials for external advisory
boards to guide protocol and product development.
Other Key Responsibilities:
- Cultivate and nurture strong collaborations, relationships and
support with Investigators, Academic partners and KOLs.
- Collaborate extensively with Business Development and Senior
R&D leadership to identify, recommend and develop strategic
alliances, partnership and licensing opportunities requiring due
diligence work and strategic input.
- Represent the team with internal and external leaders and
instill confidence in stakeholders by possessing a broad knowledge
of the pharmaceutical industry and business environment and their
impact on the product/therapy area.
- Work with Early Development Lead and other team members to
prepare abstracts, manuscripts and presentations for external
- Physician (MD is required) or physician/scientist (PhD in
relevant field is preferred) with 7-15+ years industry and clinical
- Completed fellowship in Hematology/Oncology with Board
certification. Experience Requirements:
- Strong track record in Cell Therapy clinical trials, experience
in early phase trials preferred.
- Experience establishing and working with data monitoring
committees, safety review committees, and independent response
adjudication committees. Key Competency Requirements:
- Excellent verbal, written, communication and interpersonal
- Driven by scientific curiosity with track record of independent
clinical, laboratory or translational research in the academic
and/or industry setting.
- Strong team player able to effectively communicate and
collaborate across functions and job levels.
- Willing and able to adjust to multiple demands and shifting
priorities as well as an ability to meet day-to-day challenges with
confidence and professionalism.
- Routinely takes initiative, makes strategic decisions, and is
highly engaged and accountable for all parts of assigned
- Detail-oriented with expertise in hypothesis testing methods,
statistical design and data interpretation.
Century Therapeutics Inc. is an Equal Employment
Opportunity/Affirmative Action Employer -
Minority/Female/Disability/Veteran. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, disability, age, or veteran status or any other
characteristic protected by federal, state, or local law.
Keywords: Century Therapeutics, Inc, Wilmington , Medical Director/Senior Medical Director, Early Clinical Development, Healthcare , Dover, Delaware
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