Our client is a fast growing clinical stage biopharmaceutical company, with an exciting pipeline of drug compounds at an advanced stage in research are building the next generation biotech company. They have signed off on a newly created role of Director Clinical Development for their rare disease programs in Cardiology.
This key position within the Clinical Development group will help drive recruitment in the sponsor company’s Phase 2 and Phase 3 studies for these rare disease trials. This role will be responsible for the identification, evaluation and initiation of clinical trial sites in Europe, initially for the Phase 2 studies and later for the Phase 3 planning and strategy development.
This hire will work in conjunction with the CRO and Clinical Operations team to resolve site challenges, support recruitment efforts and answer protocol related questions during trial execution. Educating the Cardiology medical community in this particular rare disease will be a key element of this role.
The appointee will ideally be based in Ireland. Alternatively, this person will operate from their own home based office in mainland Europe when not traveling. Travel is up to 30%, mainly Europe and some other international travel.
Key remit for Director, Clinical Development:
Day to day contact directly with KOLs/OLs, investigators, study coordinators, and other HCPs - as defined by territory.
Liaise with CRO, Clin Ops, and 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 enrollment and open communication re: feedback to sponsor.
Fully versed in all aspects of the protocol and program to answer immediate questions (Safety and specific patient eligibility 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 rare-disease treaters on companies KOL list in territory; Supplement KOL list as
Requirements for Director, Clinical Development:
Medical Degree (MD) and/or Advanced Degree (PhD, PharmD, MSc) in relevant therapeutic area.
8+ years of relevant clinical development / research experience in the pharma / biotech industry in cardiology, respiratory and rare-diseases.
3+ years experience as a Medical Director, Clinical Trial Liaison or Medical Science Liaison.
Broad clinical development knowledge (incl. protocol development, clinical trial design, etc.) and experience including study start-up and clinical trial execution.
Prior knowledge of European territory including prior relationships with KOLs/OLs, and investigators, and strong network within the Cardiology community.
Proven expertise in providing scientific context on specific protocol variables as well as discuss applicable disease states and competitor intelligence, complimentary to the work of CRAs / Clinical Operations, CROs, etc.
Superb communicator of technical and scientific information, multilingual a plus.
Ability to effectively present complex data and strategy to large groups.
Valid passport enabling travel throughout EU region and internationally without restriction, as required.
Exhibits high motivation and high energy level, self-starter.
For further details, please contact Larry on +353 1 – 2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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