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Director, Clinical Development

SUMMARY

The Director, Clinical Development will work closely with other members of Adaptimmune’s global Clinical, Research and CMC organizations to provide strategic direction into, as well as design, conduct and monitor the clinical development plans for specific clinical studies. The incumbent will ensure that all clinical studies operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (“GCP”) and regulatory requirements.  It is preferred that s/he will have a strong clinical and specialty background in Oncology and/or Immuno-Oncology and will be a peer among the industry, medicine and/or academic community.  The Director will provide expert scientific and clinical input to teams under the direction of the Chief Medical Officer or delegate.

 

RESPONSIBILITIES

  • Serve as the medical monitor for clinical studies
  • Responsible for protecting the integrity and conduct of clinical studies
  • Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators
  • Provide clinical review of EDC to ensure medical consistency
  • Provide strategic/tactical input into clinical development to achieve the target product profile (TPP)
  • Contribute to documents, including protocols, final study reports, and regulatory documents.  Coordinate and develop information for reports submitted to Regulatory Agencies
  • Establish and approve scientific methods for design and implementation of clinical protocol, data collection systems and final reports
  • Maintain up to date awareness of all-important advances within immuno-oncology through scientific literature, attendance at critical meetings and relationships with Key Opinion Leaders (“KOLs”)
  • Ensure that all work is carried out with regards to Adaptimmune standards and external regulations
  • Establish and maintain communications with site investigators and KOLs. Liaise with internal and external medical community to follow developments within area of expertise
  • Represent Adaptimmune, as directed, at high level external joint steering or organizing committees
  • May work on licensing agreements

 

QUALIFICATIONS & EXPERIENCE

  • PhD/PharmD or health professions degree from a recognized graduate or pharmacy school
  • Experience in designing, monitoring and implementing clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting
  • Research/translational/biomarker, immunology or oncology experience
  • Three (3) or more years of direct industry drug development experience or 3-4 years clinical trial experience in an academic setting collaborating with pharmaceutical sponsors
  • Ability to conduct a large study as part of a global team
  • Ability to function within a matrix environment; to contribute to decision-making and reaching alignment in order to meet challenging timelines
  • Ability to work collaboratively and to respect other working cultures, including academic partners
  • Ability to communicate effectively with internal stakeholders as well as external partners and collaborators; good presentation skills
  • Understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence those decision points
  • Ability to work across projects and to foster interactions between teams
  • Interpersonal skills that influence and shape the image of the organization
  • Understanding of the interplay between clinical development, CMC, commercial objectives and regulatory requirements
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