Associate Clinical Program Director
Date: Jul 6, 2018
Location: Anderlecht, BE
Our challenge. Your impact.
We aspire to be the patient-preferred global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.
At the earliest date possible we search for a Monheim/Germany, Brussels/Belgium or Raleigh/US based
Associate Clinical Program Director TA Immunology (Focus Psoriasis)
Scope of the role:
A CPD may be assigned to a Patient Value Unit (PVU) or be Practice-based. The CPD is responsible for all clinical aspects of the relevant development program(s). A CPD may have direct reports.
* A CPD may be the Lead Clinical Development Representative (LCDR) for a NCE/NBE. If functioning as an LCDR, the CPD:
* Is responsible and accountable for all clinical aspects of their assigned program(s)/ Mission(s).
* May be a member of the PVU and/or Submission Sub-Teams.
* If warranted by project scope, serves as matrix leader for ACPDs and/or CPDs who are leading other clinical aspects of a program.
The CPD is accountable for clinical strategy and leading the development and execution of the clinical development program, including but not limited to:
* Responsible for planning, designing, defending, and ensuring implementation of the Clinical Development Plans (CDP) enabling successful regulatory filings, approvals, and launches of NCEs/NBEs and additional approvals of new line extensions (indications or formulations) of registered compounds.
* Prompt identification of emerging efficacy or safety data that warrant re-evaluation of project plan and/or potential termination prior to registration.
* Coordination with LCDR to ensure harmonized approach for compound.
* Develops and maintains excellent working relationships and collaboration between the PVU and Practice to ensure broad high quality medical, scientific, regulatory, commercial and external input into the clinical programs.
* Develops a strong knowledge base of the relevant therapeutic area and drug development issues and becomes an expert for the respective treatment modality.
* Ensures that study concepts, Protocol Summaries and final protocols related to the relevant development plans are high quality, state of the art, and aligned with related CDP and Target Patient Value Profiles (TPVP); and are appropriately managed by the clinical study team(s).
* In conjunction with the publication teams serves as co-author and/or reviewer of scientific publications of results of clinical programs. Ensures transparent, ethical, and balanced dissemination of results of clinical programs regardless of study outcome.
* In conjunction with the Patient Safety team, contributes to the ongoing safety evaluation of a product with review of and/or contributions to aggregate reports, Safety Signal Detection, and revisions to Company Core Data Sheet (CCDS) and other labels.
* Contributes to broader PVU or Practice related strategic
Your responsibilities in this role include
* Represents the clinical function on the Mission Team(s) if assigned, maintaining excellent working relationships to ensure that clinical team objectives are met.
* Maintains the CDP, ensuring that it meets the requirements of the PLC and the TPVP.
* In conjunction with the Program Physician, oversees the ongoing evaluation of the benefit/risk ratio of the compound.
* Leads the team in the planning and execution of high quality clinical components of regulatory submissions for the indication/formulation (e.g., study reports, summary documents). Reviews and contributes to such components. Responsible for on-time delivery of clinical components of regulatory submissions. Represents the company at meetings with Regulatory Authorities.
* With the Medical Directors of the Clinical Practice, develops and manages a network of external experts relevant to the company's development programs. Collaborates within UCB and externally to acquire competitor intelligence from the public domain and applies it to the benefit of product under development.
* Represents the company and speaks at conferences, symposia, and meetings with Key Opinion Leaders.
* With the Clinical Project Managers, ensures that clinical trial activities are executed efficiently (e.g. within agreed timelines and budget) and to a high standard, meeting all appropriate regulatory requirements. Ensures appropriate planning and forecasting of budget requirements for the clinical program.
* Ensures compliance of program(s) with all applicable regulations, SOPs, company processes and ICH GCP and quality standards applicable to UCB.
* Working with Clinical Quality Assurance, ensures that the overall clinical program is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.
* Shares knowledge: The CPD is responsible for sharing the knowledge of the clinical program with all appropriate parties, across the PVU, Practice and UCB. The aim should be to make programs more efficient and to make the "lessons learned" in current programs available for future programs. Ensures regular debriefings, and searches for the appropriate expertise inside and outside of the PVU and Practice.
Your qualifications and experience level for this role:
* Master degree required with a PhD, PharmD or Medical Degree preferred
* Depending on previous professional experience, a minimum 5 years experience in biopharmaceutical clinical development is required, including the management of multiple clinical studies.
* Experience in writing and/or participation in the preparation of submission documents (including safety updates) preferred.
* Knowledge of all aspects of the clinical development process required, and of the relevant therapeutic area preferred.
* Drug safety experience is preferred but not required.
Have we made you curious?
Then we look forward to receiving your online application (please only use our online application tool) for this position stating your earliest availability or actual notice period as well as salary expectations. We thank you for your interest in UCB and look forward to get in touch with you! UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7500 people in approximately 40 countries, we generated revenue of EUR 4.5 billion in 2017.
Do you want to find out more about us then visit our website: www.ucb.com
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