Responsibilities will include: Responsible and accountable for the conduct of clinical trials. Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality. Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles). Work collaboratively with cross functional internal and external teams including regulatory affairs, medical writing and biostatistics. Identify, qualify, audit, and manage all external vendors, including CROs. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives. Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, local regulations, ICH GCP guidance, and study protocol. Identify any gaps in company/CRO SOPs and develop internal SOPs as needed. Responsible for ensuring the trial is “audit ready” at all times. Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported. Provides regular updates to management team, vendors and contract staff concerning status and progress of the trial.

Manager- Clinical Research• Medical liaison with clinicians, academics and research scientists in therapeutic areas of interest to UCB, for the purposes of clinical research.• To develop and support local registration trials, Phase IIIb and IV Studies, including management of requests for compassionate use / named patient programmes.• To conduct clinical studies (phase III & IV) for existing and new UCB products, report to Corporate, Medical and Regulatory Director and General Manager on adverse events, and take remedial action in line with Corporate guidelines and policies• To ensure the availability to the affiliate of all relevant scientific data on new and existing UCB products.• To communicate scientific data developments to relevant colleagues on the medical profiles and the latest scientific data related to UCB products.• To support investigator sponsored studies within applicable regulations• To interact effectively with clinical development (and global medical affairs for GMA studies) to represent affiliate medical environment in the review of clinical development plans for products in development and to ensure that India is appropriately represented in registration trials.• To ensure that all clinical studies are run in accordance with ICH-GCP and with the regulations applicable in India.• To facilitate interaction with GCD and GMA on daily issues of development studies that are run in India