Job Description
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 Associate Director of Clinical Development based in Ireland, with hybrid working model. This is a Global role, will assist/build Clinical Development function and manage multiple Global Clinical Programs.
The successful candidate will lead multiple clinical trial programs in oncology clinical development. For these assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities including 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 Clinical Development role and have proven knowledge of regulatory requirements, with demonstrated experience in ensure the company meets regulatory, scientific, and business objectives.
Responsibilities for Clinical Development Associate Director:
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
Provides input into 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 Clinical Development Associate Director:
MD, PharmD, PhD 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 working on and with cross-functional project / program teams in clinical research or development is preferred.
Experience supporting clinical study design, medical monitoring and regulatory filings.
Experience supporting clinical publications and presentations is preferred.
Additional Requirements:
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Proven analytical abilities as demonstrated through past experience and/or academic research.
Understands drug development phases and the nature of associated clinical trials across phases.
Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
Has advanced knowledge of major disease areas, as evidenced by effectiveness supporting clinical projects.
Strong communication and organizational skills.
Ability to travel on occasion, as required.
For further details please phone Larry on +353 1-2302400 / larry@rftgroup.ie
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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