Director, Clinical Development
- Experience Level
- Senior Management
Job Title: Director, Clinical Development
Location: Dublin, Spain or Germany
We're looking for an MD or PhD to both support the clinical trial sites and work with KOL's to further educate them on the company's programs.
The Director, Clinical Development is a key position within the clinical development group that will help drive the company's phase II and III studies within the pulmonology and cardiovascular space. The role will be responsible for identifying, evaluating and initiating clinical trial sites across Europe, initially for a Phase II study and later for the Phase III planning and strategy development.
You would work in conjunction with the CRO and Clinical Ops team to resolve site challenges, support recruitment efforts and support the sites throughout trial execution. Another key responsibility includes educating the Pulmonary Hypertension medical community on the company and their Pulmonary Hypertension programs.
Scope of Responsibilities:
- Day to day contact with KOLs, investigators, study coordinators, and other HCPs - as defined by territory
- Liaise with CRO, Clinical Operations, and the study Medical Monitor to provide site recommendations based on prior knowledge of territory/investigators/allied health; participate in SIVs
- Leverage past relationships to ensure interest and commitment from sites/investigators for study enrolment and open communication
- Fully versed in all aspects of the protocol and program to answer immediate questions
- Provide feedback on specific sites and regional trends/thoughts/paradigms to identify and/or inform potential protocol amendments, accrual barriers, patient/study subject identification
- Establish relationships with all PAH treaters on the KOL list in territory; Supplement KOL list as appropriate
- Provide clinical and scientific support in all aspects of the clinical development program, including the design, preparation, conduct, monitoring, analyses, and reporting of the studies
- Provide input to protocol endpoint consideration for future PAH studies
- Understand the analysis and interpretation of data
- Cultivate strong relationships and robust communication among the clinical study/project team and the development organization
- Liaise with other internal functions as needed to support the PAH program
- Advanced degree (MD, PhD, PharmD)
- 1- 5 years experience in PAH preferred or in pulmonology and/or cardiology and/or rare disease.
- 1-3 years experience as a Clinical Scientist, MSL or Medical Director
- General clinical development knowledge and experience including study start-up and clinical trial execution.
- Strong clinical knowledge of etiology/pathology of cardiovascular and/or pulmonary diseases and patient management issues especially Pulmonary Hypertension
- Experience with relationship building and expanding a company’s reach
- Adaptability to changing landscape and ability to pivot quickly as new information becomes available
- Prior knowledge of territory, prior relationships with KOLs and investigators, and strong network within the PAH Community.
- Up to 25% travel
To find out more, please contact Christopher Gibson, Head of Life Sciences at Usurpo on email@example.com or 0044 7508 061 234
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