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Ipsen · 4 weeks ago

Sr. Clinical Development Director, NEUROSCIENCE (REMOTE)

United States

Full-time

Remote

Lead/Staff, Director/Executive

5+ years exp

Ipsen Innovation (SAS) is a global biopharmaceutical company focused on transformative medicines in areas such as Neuroscience. The Sr. Clinical Development Director will be responsible for developing the Therapeutics Clinical Development Plan and overseeing clinical development programs, ensuring compliance with medical guidelines and managing cross-functional relationships.

BiotechnologyPharmaceuticalProduct Research

H1B Sponsor Likely

Responsibilities

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

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)

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

Qualification

Clinical DevelopmentNeurologyDrug DevelopmentMedical Doctor (MD)Clinical Trials ManagementScientific PublicationsTeam LeadershipCross-functional Collaboration

Required

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)

Preferred

Formal training in Neurology

Company

Ipsen

Glassdoor3.7

Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care.

Founded in 1929

Boulogne-billancourt, Ile-de-France, FRA

5001-10000 employees

http://www.ipsen.com

H1B Sponsorship

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