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 Slough based
(Senior) Medical Director (Clinical Development - Therapeutic Area Immunology)
who can support our Clinical Development team.
Nature & Scope
The Medical Director, Clinical Development is accountable for providing medical expertise and medical leadership into clinical development strategies to allow project teams to successfully deliver the clinical studies aligned with the Target Patient Value Profile (TPVP) and Clinical Development Plan (CDP). The focus will be on all aspects of clinical drug development including but not limited to medical input into indication selection, assessment of current and future treatment strategies, unmet need, target patient population, TPVP, clinical development plans, clinical study protocols and reports, regulatory submission documents.
The Medical Director, Clinical Development will achieve this as a key member of interdisciplinary matrix teams developing and executing high quality, innovative, state-of-the-art and feasible clinical development programs. The Medical Director, Clinical Development will be seen as a medical expert in the therapeutic area and will partner with all key team members to provide UCB development projects with high quality medical expertise.
The Medical Director, Clinical Development will ensure the study-related safety of the subjects in UCB sponsored clinical trials through appropriate oversight of the medical monitoring of studies on an ongoing basis – with or without independent data and safety monitoring boards.
The Medical Director, Clinical Development will establish and maintain a network of KOLs with expertise in running clinical studies in the therapeutic area of interest (with a focus on Phase 2 and 3). In addition to project related assignments the Medical Director, Clinical Development will work with internal and external partners and stakeholders to enhance the use of innovative methodologies of clinical data collection and analysis in clinical studies.
Strategy and Leadership
- Provide medical/scientific expertise input into project teams developing and executing clinical development programs for patient solutions in the related therapeutic area (with focus on post-POC Phase 2 and 3)
- Work in close partnership with all key team members of clinical and project teams to ensure all medical aspects of the CDP are of high quality, innovative, state-of-the-art and aligned with the TPVP
- Establish KOL network in respective therapeutic area
- Establish and oversee appropriate Medical Monitoring concepts
- Provide medical expertise into indication selection, assessment of current and future treatment strategies, unmet need, target patient population, TPVP, CDP, clinical study protocols and related feasibility assessments, clinical study reports and regulatory submission documents and other documents with content of medical relevance
- Provide training and ongoing input on medical/scientific issues related to the respective therapeutic area
- Collaborate with relevant UCB departments in order to follow-up the operational implementation of the medical monitoring of assigned clinical studies or clinical development programs
- Medical Monitoring; In case Medical Monitoring is assigned to partner CRO, provide oversight on these activities.
- Play a key role in the pre-analysis data review and data interpretation meetings.
- Serve as global medical/scientific spokesperson or key contributor for UCB with the internal and external community including various regulatory and governmental agencies (for post-POC clinical programs).
- Represent UCB as medical/scientific expert at conferences, symposia, and meetings.
Your qualifications and experience level for this role:
Education & Experience
- Medical qualification (MD)
- Specialty training in rheumatology, internal medicine, or clinical immunology preferred
- Experience in the pharmaceutical industry, CRO or equivalent with significant clinical development experience in Phase 2 and 3 (ideally in different therapeutic areas, including immunology relevant therapeutic areas)
- Experience as medical expert in interactions with regulatory authorities
- Profound knowledge of clinical development, including regulatory framework
- Ability to communicate effectively with internal (including senior and executive management) and external key stakeholders (including regulatory authorities)
- Strong team player with ability to work in matrix teams in global and diverse environment
- High performer, ability to work independently to solve complex problems and ability to support multiple projects as medical expert, if appropriate
- Strong data-driven thinking and ability to interpret medical/scientific data and clinical relevance
- Strong motivation by medical/scientific excellence and creation of differentiated patient value
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 4.2 billion in 2016. UCB offers competitive salaries according to candidates' qualifications.
Do you want to find out more about us then visit our website: www.ucb.com
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