Our client, a cutting edge scientifically driven Biotech company with strong development pipeline and multiple blockbuster products, now seek a unique appointment for a newly created role of Director of Clinical Development based in Ireland, with hybrid working model. This is a Global role, will build Clinical Development function and manage multiple Global Clinical Programs.
The ideal candidate will be an experienced Biopharma/ Pharma M.D., who is experienced in working across multiple organizational levels, including leadership teams, executives and steering committees, leading global program direction and status to varying teams.
The successful candidate will lead multiple clinical trial programs in pediatric oncology clinical development. Additionally, you may act as the Physician responsible on certain projects with accountability for various aspects of ongoing clinical trial program-related activities.
These activities include, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
This hire will work collaboratively with R & D/Biometrics, Epidemiology, Pharmacovigilance, Global Drug Safety, Clinical Research, Clinical Data Management, Regulatory and Project Management management/staff to meet program deliverables and timelines.
The ideal candidate will be operating in similar role and have proven knowledge of regulatory requirements, with demonstrated experience in ensure the company meets regulatory, scientific, and business objectives.
Responsibilities for Director, Clinical Development:
Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
Provides input into, or otherwise leads, pediatric study plans, clinical trial protocol design, clinical study reports and health authority inquiries.
Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Coordinates the collection and assimilation of ongoing data for internal analysis and review.
Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings.
Adheres to regulatory requirements of study conduct and industry standards of GCP and SOPs.
Requirements for Director, Clinical Development:
MD or equivalent with relevant years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
Board certification in Oncology is preferred, including familiarity with pediatric oncology.
Experience in the biopharma industry is preferred.
Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
Preferred abilities and expertise:
Proven analytical abilities as demonstrated through past experience and/or academic research.
Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
Proven experience in communicating project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
Ability to travel on occasion, as required.
For further details please phone Larry on +353 1-2302400 / email@example.com
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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