Sr. Medical Director, Cell Therapy Clinical Trials in Hematologic Malignancy

Location
Philadelphia, PA, United States
Posted
May 05, 2022
Ref
3055618090
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Position Title: Sr. Medical Director, Cell Therapy Clinical Trials in Hematologic Malignancy

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.

Responsibilities:

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 stakeholders.
  • Oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CSRs and clinical expert reports.
  • Build investigator relationships for multiple hematologic malignancy indications and protocols.


Interaction with Health Authorities:
  • Drive clinical trial protocol development and execution through regulatory filings.
  • Provide clinical leadership to allow for initiation of US and global trials in collaboration with regulatory and clinical operations team members.


Clinical Development:
  • 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 meetings.


Qualifications:
  • Physician (MD is required) or physician/scientist (PhD in relevant field is preferred) with 7-15+ years industry and clinical experience.
  • 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 skills.
  • 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 projects.
  • 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.