Clinical Development Director

Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support?  If so, this Clinical Development Director opportunity could be an ideal opportunity to explore.

I. Role Purpose

The Clinical Sciences Lead (CSL) is the single point accountability for the development of the scientific design, medical governance (if a physician) and interpretation of results of a study. The study designed is expected to fulfill a strategic objective of the clinical development or integrated evidence plan.

II. Key Accountabilities

Single point of accountability for the following:

Study Design

•  Study design, including integrated input from internal/external experts, thought leaders and patients Ø
• Study objectives are consistent with decision criteria in the CDP (i.e. ensuring Go/No-Go criteria has been set) Ø
• Appropriate incorporation of design of study into protocol Ø PRF reviewed and approved clinical study proposal (CSP) Ø
• Presenting the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct

Scientific Oversight for the Study

• Benefit risk of the study Ø
• Ensuring study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results Ø
• Clinical monitoring and ongoing review of clinical data and study conduct to assure patient safety and scientific integrity. This would include ongoing review of protocol deviations and implementation of remedial plans Ø
•  Medical governance for the study
  • If a physician: Medical governance of study, including medical monitoring
  • If not a physician: The CSL is expected to delegate on a study physician, the medical governance accountability and interface closely with her/him for advisory information on benefit risk

Evidence Generation & Outputs for the Study

•  Interpretation of study data to create the scientific content of Clinical Study Report (CSR)
•  Preparation of study results for abstracts, posters and presentations for scientific meetings, congresses, external journal publications
• Preparation of clinical content of regulatory documents and interaction with global regulatory authorities for the study
• Provides input into and reviews other relevant study document including the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM)

• Provides scientific content for other study specific documentation (e.g. slides for site/monitor/investigator training)

4) Study Level Collaboration

•  Partner with the Study Delivery Lead to ensure optimal delivery of the study
• Maintaining close collaboration with various functions including: drug safety, regulatory affairs, medical affairs and clinical trial operations at the study level

III Core Competencies

• Strategic assessment and decision making when designing clinical studies Ø
• Interfaces relevant scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical studies
• Embraces challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areas Ø
• Embraces creative thinking and coming up with innovative business solutions Ø
• Solid understanding of clinical research and biostatistics principles, to facilitate innovative and efficient clinical trial design, that supports the clinical development plan with clear data-driven decision rules
• Uses sound judgment, statistics, and visualization techniques to interpret or analyze moderately complex information and make correct inferences and conclusions. Analyses, interprets and critically evaluates data, information and digital content Ø
• Ability to respond with confidence to more complex questions using sound judgment Ø
• Awareness of the importance of work undertaken in support of the medicine vision and lifecycle management plan Ø
• Demonstrated experience contributing projects and working collaboratively with multiple stakeholders
• Ability to research and use data from a range of sources to make robust fact-based decisions, employing diverse and critical thinking Ø
• Experience leading line or matrix teams at the study level

Why you?

Basic Qualifications:

We are looking for professionals with the required skills to achieve our goals:

• Bachelor’s degree in a science related field (Infectious Disease preferred)
• Experience participating in above gl