Clinical Program Leader, R&D Global Rare Diseases

Purpose

•    Act as a core Member of the Product Project Team and as the Leader of the Extended Clinical Team, responsible for the global clinical strategy of the product and the Clinical Development Plan, in accordance with the Target Product Profile and Product Development Plan and regulatory requirements.
•    Accountable for the clinical programme for product registration and corporate lifecycle management on a world-wide basis.
•    Represent the Product(s) Clinical Expertise inside and outside the company.

Main Responsibilities

•    Act as a core Member of the Product Project Team and as the Leader of the Extended Clinical Team, contributing to the development of the Target Product Profile and the Product Development Plan, and responsible for the global clinical strategic development of the product, and the Clinical  Development Plan in accordance with these documents and regulatory requirements.  Compile, appraise and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data
•    Accountable for the clinical programme of GRD products through registration and corporate lifecycle management on a global basis, as well as accountable for delivering the Key Clinical Documents according to the agreed timelines and expected quality.
•    Represent the disease state and product(s) Clinical and Scientific Expertise inside and outside the company, acting as a spokesperson for Chiesi (internally and externally) on clinical aspects of the product(s), as well as acting as mentor and coach of junior/industry inexperienced Clinical Research Physicians and Clinical Research Scientists.
•    Assume accountability for the Key Clinical Documents (even though can delegate tasks to Clinical Research Physician and/or Clinical Research Scientist), in detail : Clinical Sections of Investigator’s Brochure, Clinical Sections of Investigational Medical Product Dossier, Protocols, Protocol amendments &  Clinical Study Reports, Clinical Overview/Clinical Summaries in CTD, Clinical Sections of Regulatory Packages, and publications of data from Clinical Studies.
•    Author (and owner) of the global (worldwide scope) Clinical Development Plan, designing the plan, ensuring that the leanest plan is devised to achieve product approval and subsequent label extensions in all regions of interest as per regulatory requirements, the timely and high quality execution of the plan through delegation of activities to relevant roles (Study Manager, Clinical Research Physician/Scientist, Data Manager, Statistician and Clinical Trial Supply Coordinator), and the design of post-registration clinical studies to secure growth of  the brand into the market place, in line with the Lifecycle   Management Plan and in collaboration with Medical Affairs.
•    Be accountable for the application of state-ot-the art procedures within studies and integrated strategy across studies to fulfil regulatory requirements, and for the application of company standards and achievement of agreed KPIs.
•    Lead the interpretation of clinical data to enable a deep and profound understanding of the disease and patient characteristics and the treatment response, work with the statistician(s) on the Statistical Analysis Plan, define, prioritize and interpret exploratory analyses, evaluate the overall risk-benefit profile, interpret data in relation to programme (i.e. in the context of the totality of the data) and external competitors, consult KOLs to discuss emerging data.
•    Anticipate patients management trends, identify new clinical opportunities for product growth and propose options to Project Team.
•    Provide high-quality clinical and scientific input into the evaluation of new products and business development opportunities for in-licensing or acquisition in GRD, including identifying clinical / development risks and opportunities and designing the clinical development plan.
•    In general, act in compliance with ICH/GCP, SOPs and Regulatory Guidelines.
•    Sign off the clinical document approved by the Protocol Review Committee.

Experience Required

•    Significant experience in clinical research including relevant experience in the pharmaceutical or biotech industry.     
•    Track record of achievements in academic or industry-sponsored clinical studies.
•    Specific therapeutic area qualifications/experience.

Education

•    Medical Doctor Degree or equivalent Life Science Degree 
•    Background knowledge in rare diseases is highly desirable

Languages

English fluent

Technical Skills

•    Knowledge of clinical research elements (especially in rare diseases)
•    Knowledge of rare disease drug development processes and regulatory affairs’ environment
•    Experienced in project leadership.
•    Experienced in compiling Clinical Plans.
•    Experience in clinical study management and oversight.
•    Knowledge and experience in regulatory strategy and requirements.
•    Experienced in compiling regulatory dossiers.
•    Experienced in defending a regulatory submission in front of a regulatory body
•    Experienced in Phase 2 to 3 of clinical development.
•    Experienced in clinical development in rare diseases.
•    Experienced in preparation of clinical/medical/scientific documents (e.g. protocols/reports, manuscripts).
•    Experienced in product development and evaluation of new opportunities (desirable)

Soft Skills