Sam Whyley-Smith is recruiting for two Senior Clinical Development Leadership positions within a leading global pharmaceutical company based in the Hertfordshire area on a permanent basis. Both positions would be at Medical Director / Senior Medical Director level, with one role focused in early phase and the other role focused in late stage clinical development of innovative molecules for the treatment of multiple tumor types.
The Role(s):
The Medical Director is responsible for input and oversight for early/late stage clinical development plans within the oncology department, from preclinical research, First in Man studies through Phase I/II/III Clinical Trials.
The successful applicant(s) will be responsible for leading a cross functional study team and a team of direct reports. The main purpose of the role will be to oversee a series of oncology trials, draft study specific documentation such as NDA/CTA submissions and Investigator Brochures, alongside reviewing study data and providing expert advice to aid in the development of their oncology portfolio.
Further Key Responsibilities:
- Directing and overseeing clinical research plans, and providing input to help integrate the Clinical Development Plan with the Drug Development Plan
- Serving as the clinical/medical team expert to provide direction to all project team functions, regularly liasing with KOL's and organising Advisory Board Meetings
- Implementing strategies to identify, monitor and resolve clinical/program trial issues
- Reviewing/ monitoring safety study data and providing clinical expertise and content to regulatory documents
- · Proactively and independently find solutions and drive innovation
Your Background:
- Educated to Medical Degree
- Board Certification or Eligibility in Oncology is preferred; will consider candidates with Oncology Clinical Development experience in lieu of Board Certification
- Demonstratable experience in oncology clinical trial management
- Ability to influence others; self starter with an inquisitive nature and practical approach to problem solving
- Demonstrated competence as Study Director/Medical Monitor and prior experience working with the FDA or EMEA on responses to inquiries for study related information is preferred
- Clinical experience and academic track record in solid tumors or hematologic malignancies is desirable
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45233 in all correspondence.