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Sr. Clinical Development Director, NEUROSCIENCE
il y a 1 heure
The Clinical Development Lead for Therapeutics, in the Global Neuroscience Therapeutic Area team, will have the following missions:
- Responsible and accountable for the development of the Therapeutics Clinical Development Plan (CDP) and medical aspects of the Integrated Asset Strategic Plan (IASP) of Ipsen's individual asset/indications in neurology as directed by the Asset Lead and TA head within the frame of the Asset Team and in accordance with Target Value Profiles (TVP) as developed by the Asset Team.
- Direct Supervision of one or more clinical development directors and clinical scientists responsible for the delivery of clinical development programs as assigned
- Works closely in partnership with all functions represented in the Asset Team: Regulatory Affairs, Clinical Operations, REED, Global Patient Safety, Medical Affairs, Business Development, legal and commercial Franchise Neuroscience in providing medical support for drug development programs and clinical/medical evaluation of the assigned asset/indication. Recognized as influential leader, develops, proposes, and influences project and R&D teams on new uses for compounds currently in proof of concept and/or life cycle management
- Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration
- Leads his team to provide pivotal medical input to Ipsen's individual Neuroscience therapeutic medicine assets to support regional and/or global drug development
- Ensures their team from a medical perspective complies with GCP, ethical, scientific and medical guidelines and statutory principles throughout all clinical development activities
- Consistently works within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results
- Manages effectively relationships in a cross functional and matrix environment with internal and external stakeholders
- Advises Asset Lead and Neuroscience TA Head on critical issues deserving immediate attention and escalation, proposing actionable solutions
Main Responsibilities / Job Expectations
Main Tasks
- Leads their team in developing all medical, scientific, strategic and clinical matters both in Asset Team and sub-teams related to therapeutic drug development programs from lead compound identification to product registration and launch
- Lead the cross functional Global Workstreams within the Asset Team with overall responsibility to build therapeutic clinical development plans for a specific Drug Development program/indication,
- Supervises the Medical responsible team members in ongoing clinical trials and assures they contribute within the individual study teams to set-up, conduct and interpret study results
- Reviews and Co-authors medical parts of study and asset related materials (protocols, amendments, DSUR, IB, clinical study reports, scientific advice briefing books, etc.)
- Provide medical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IASP
- Supervise the study medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Value Profile (TVP) and IASP
- Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen studies in relation with the assigned asset/indication
- Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen R&D Neuroscience TA at investigator meetings, advisory boards, scientific conference or alike
- As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects within the Neuroscience area.
- Liaise with key internal experts as required to support pre-clinical and clinical programs and other Asset Teams for most efficient development of new products
- Liaise with REED department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies)
General duties and responsibilities
- Comply with Ipsen's SOPs, GCP, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research
- Develop and maintain state of the art scientific, medical and managerial knowledge by:
- Establishing and maintaining an external professional network
- Reading pertinent scientific and medical publications
- Attending pertinent training courses, workshops, conferences etc.
- Commit to support transformation and change management of R&D division with a focus on high performance culture, data quality, timeliness and budget control accounts
- Assume tasks within the context of team performance and project progress in an objective-driven, solution and results oriented manner with an overall can-do attitude
- Be a proactive member and contributor to Ipsen's medical community
Knowledge, Abilities & Experience
- Medical Doctor (MD)
- Minimum 5 years' proven experience in Clinical Development (from pre-clinical to registration)
- Substantial scientific and academic experience (preferably with clinical trial experience); with state-of-the-art medical, scientific knowledge; and track record of successful publications
- Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management
- Previous experience directly and independently leading projects and/or a team of professionals
- Previous experience on transversal projects (with other functions) and multiple therapeutic areas and
- stages of drug development, exhibiting the ability to influence others (above and beyond ones' own
- function)
- Formal training in Neurology preferred
