Senior Director, Clinical Research, OBG - Hatfield
Brandon Whates is recruiting for a Senior Director, Clinical Operations for a permanent role with a leading pharmaceutical company in Hertfordshire on a full-time, permanent basis.
The Senior 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 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 Phase I - III 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
- 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
For more information or to apply for this position, please contact Brandon Whates on 01438 768715 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. 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.