The Medical Director/ Senior Medical Director 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 programs.
The incumbent will ensure that all clinical programs operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (“GCP”) and regulatory requirements.
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 within the field of pharmaceutical medicine and/or area of Immuno-Oncology specialty.
The Medical Director will provide expert scientific and clinical input to teams under the direction of the Vice President of Clinical Development.
Representative responsibilities will include, but not necessarily be limited to, the following:
- Serve as a program level physician and medical monitor for clinical studies.
- Have responsibility 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 strategic/tactical input into clinical development and commercialization programs and data interpretation.
- Contribute to and author 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. Answer protocol related questions from site investigators.
- Maintain up to date awareness of all-important advances within Immunotherapy 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 clinical investigators and KOLs. Work with internal clinical operations team to ensure appropriate infrastructure is available to conduct clinical trials, and liaise with internal and external medical community to follow developments within area of expertise.
- Establish and maintain communications with site clinical investigators and KOLs.
- Represent Adaptimmune, as directed, at high level external joint steering or organizing committees.
- May work on licensing agreements.
Experience / Qualifications:
- M.D., with clinical development experience in pharma preferred; with Research/translational/biomarker, immunology or oncology experience also preferred. Graduate of a recognized school of medicine with an M.D. degree or equivalent.
- Board Certification or Eligibility in Oncology is preferred; specialty training and/or clinical experience and strong academic track record in Immuno-Oncology, Tumor Immunology, or Immunotherapy is preferred. Hematology background or other specialties in medicine will also be considered.
- Direct industry drug development experience within pharmaceutical or biotech required
- Experience in designing, monitoring and implementing clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting.
- 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.