[Hiring] Lead Clinical Development Director @Ipsen

Role Description

The Lead Clinical Development Director, Rare is responsible for overseeing clinical matters related to drug development programs from lead compound identification to product registration and launch.

• Support in all clinical matters for Project Teams and drug development programs.
• Provide clinical, scientific, and strategic expertise, contributing to and/or preparing clinical trial-related documents, including:
  • Investigator Brochure
  • Communication with regulatory authorities
  • Clinical trial synopses
  • Clinical trial protocols
  • Clinical summaries
  • Clinical Study Report
• Ensure execution of Clinical Development Plan (CDP) and establish cross-functional alignment as necessary.
• Make final decisions on clinical matters for clinical study teams.
• Work on complex issues requiring in-depth knowledge of relevant programs and therapeutic areas.
• Act as a resource for clinical study teams and relevant project teams.
• Regularly interact with major internal and external stakeholders (KOLs, Investigators, experts).
• Support the conduct of clinical trials as part of the Clinical Study Team.
• Contribute to clinical monitoring to ensure data integrity and coherence of data interpretation.
• Contribute to and review scientific communication (abstracts, articles, presentations) of Ipsen-sponsored studies.
• Establish and maintain professional relationships with external medical experts and key thought leaders.

Core Remit of Activities External to Therapeutic Area Development (approx. 35%):

• Liaise with pre-clinical and early development teams to ensure scientific and medical integrity of IDP, TPP, etc.
• Participate in competitive intelligence and/or other market/industry assessment activities within the oncology area.
• Liaise with key internal experts to support pre-clinical programs and Project Teams.
• Provide medical expertise for ongoing programs and possible new external assets.
• Liaise as medical expert with External Innovation and business development teams.

General duties/responsibilities:

• Comply with Ipsen’s SOPs, GCP, governmental policies, regulations, and applicable laws.
• Develop and maintain scientific, medical, and managerial knowledge by:
  • Establishing and maintaining an external professional network.
  • Reading pertinent scientific and medical publications.
  • Attending relevant training courses, workshops, and conferences.
• Support transformation and change management of R&D division.
• Assume tasks within the context of team performance and project progress.
• Be a proactive member and contributor to Ipsen’s medical community.

Qualifications

• Advanced degree in a relevant field (MD, PhD, etc.).
• Extensive experience in clinical development within the biopharmaceutical industry.
• Strong knowledge of regulatory requirements and clinical trial processes.
• Excellent communication and interpersonal skills.
• Proven ability to lead cross-functional teams.

Requirements

• Ability to work in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Willingness to travel as needed.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and career growth.
• Flexible working arrangements.