Job Highlights
Not Disclosed
Posted 7 months ago
Job details
Purpose of the position
The Medical Development Director, in the Global Neuroscience Therapeutic Area team, will have the following missions:
This Position
Core Remit of Activities Internal to Therapeutic Area Development (approx. 75%)
The Medical Development Director, in the Global Neuroscience Therapeutic Area team, will have the following missions:
This Position
- 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
- Works closely in partnership with Global Neuroscience teams: External Innovation, Early Development, Regulatory Affairs, Drug Safety, Medical Affairs, Business Development, legal and commercial Franchise Neuroscience in providing medical support for drug development programs and clinical/medical evaluation of new BD opportunities
- Delivers high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data in fulfilment of the development business objectives for registration
- Provide pivotal medical input to Ipsen’s individual Neuroscience drugs, including but not limited to recently acquired assets, and to support regional and/or global drug development
- Ensures from a medical perspective compliance 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 SVP TA on critical issues deserving immediate attention and escalation, proposing actionable solutions
Core Remit of Activities Internal to Therapeutic Area Development (approx. 75%)
- Support in all medical, scientific, strategic and clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch
- Serves as the clinical referent for due diligence activities
- Participate with TA Head and other senior managers in establishing strategic plans and objectives for new Neuroscience assets
- 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 IDP
- Contribute to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Patient Profile (TP) and IDP
- Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies
- 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
- Proactively liaise with Global Drug Discovery to ensure scientific and medical integrity of IDP, TPP etc.
- 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 programs and Project Teams for most efficient development of new chemical entities
- Liaise with Early Clinical Development platform and Clinical Pharmacology department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies)
- Liaise as medical expert with External Innovation and business development teams to optimize the due diligence activities
- 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
- Medical Doctor (MD) preferred
- Minimum 5 years’ proven experience in Clinical Development or Neuroscience development area (from pre-clinical to registration) preferred
- 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)
- Bilingual (English & French) required
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- France
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 12, 2024
Company Overview
Ipsen
Current Openings: 0
Ipsen is a French leading global mid-size biopharmaceutical company headquartered in Paris, France focusing its efforts where unmet medical needs are greatest. Ipsen develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Rare Disease and Neuroscience. We have over 5000 employees worldwide and our medicines are registered in more than 100 countries, with direct commercial presence in over 30 countries. Ipsen has 4 global R&D hubs and 3 pharmaceutical development centers around the world.
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