Contract Clinical Development - Oncology

Highly Competitive
Hertfordshire
Posting date: 15 Jul 2019
CR.DM.24327_1563206636
This vacancy has now expired

A global leading pharmaceutical company is seeking a Clinical Development Contractor (Oncology) to join their team in Hertfordshire, UK.

Job Role:


The Contractor, Clinical Research, Oncology within the Clinical Development Department is responsible for providing the medical input and medical oversight for early or late stage Oncology clinical development programs. Strategic responsibilities include design and execution of clinical development plans for oncology products from preclinical research, First in Man studies through Phase I/II/III Clinical Trials.

Responsibilities:

  • Directs and implements clinical research plans and programs according to established design principles
  • Directs the integration of the CDP and the DDP
  • Leads the development of Clinical Protocols to meet CDP objectives
  • Serves as Study Director and drives the execution of the study from protocol concept to final report including interpretation of clinical data
  • Serves as Medical Monitor and possibly Study Director for a study or clinical program, reviews and monitors study safety data
  • Implements strategies to identify, monitor and resolve clinical program/ trial issues
  • Serves as SME to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), and identifies and liaises with KOLs regarding program strategy and scientific advice
  • Interprets study data and develops integrated summaries of safety and efficacy
  • Contributes clinical expertise and content to regulatory documents (e.g. briefing books, NDAs etc.)
  • May represent Clinical in discussions with Health Authorities
  • Manages new tools and resources (tools, systems, vendors, etc.) while minimizing their costs to the organization
  • Sets key deadlines and project milestones for projects within the function
  • Manages contractors and ensures that contractors, consultants and vendors complete assigned work according to agreed timelines
  • Makes appropriate budgetary allocations to targeted opportunities
  • Evaluates appropriateness of requests for increased budgets
  • Directs the use of financial standards across work teams for consistent level of compliance
  • Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves discrepancies
  • Complies with all applicable laws / regulations of each country in which we do business
  • Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
  • Reports legal, compliance and ethical violations in a timely manner

Education, Skills and Experience:

  • Advanced in clinical trial design & execution, clinical and drug development planning
  • Advanced business and regulatory knowledge
  • Expert level knowledge in therapeutic area

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at d.mistry@Proclinical.com or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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