Medical Development Director (Remote-Based)
Ipsen Bioscience, Inc.
Medical Development Director, Rare Disease (Remote-Based)
Purpose of the position
Reporting to the Senior Medical Development Director, the Medical Development Director (MDD) for the Rare Liver Disease Program (for a rare disease asset in hepatology, currently in phase III as well as potential new investigational assets) will provide medical guidance and leadership in the implementation, monitoring and interpretation of the ongoing Phase 3 and additional clinical trials to support global approvals for rare liver diseases.
- Design, implement and monitor clinical development studies towards global regulatory approval and beyond
- Provide medical input on required regulatory documentation and responses to questions from global regulatory agencies
- Help draft clinical sections of regulatory filings, Phase 1, II, and II clinical protocols, analysis plans and trial reports.
- Provide medical oversight on safety reporting for the ongoing clinical trials
- Establish and provide clinical and scientific leadership to investigators, advisory boards, and consultants to guide clinical development
- Represent Ipsen at scientific and patient-centered meetings
Core Remit of Activities Internal to Therapeutic Area Development
- Support in all medical, scientific, strategic, and clinical matters for rare liver disease drug development programs from lead compound identification to product registration and launch
- Supports the Senior MDD in any rare liver disease activities, including clinical reviewer for due diligence activities for future assets
- Ensures from a medical perspective compliance with GCP, ethical, scientific, and medical guidelines and statutory principles throughout all clinical development activities
- Participates with TA Head and other senior cross-functional leaders in establishing strategic plans and objectives for rare liver disease portfolio.
- Contributes to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies
- Works closely with the CRO Medical Monitor, provide medical oversight for all clinical trials
- Maintains close communication with the data monitoring committee or independent review committee providing oversight to the quarterly safety reviews as well all safety alerts and endpoint adjudication
- Works closely with the Clinical Scientist assigned to projects
- Provide medical, scientific, and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure updates, communication with regulatory authorities, clinical trial amendments, clinical summaries, Clinical Study Reports, with the support of other R&D functions and in line with IASP
- Contribute to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Patient Profile (TP) and IASP
- 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 Rare Disease TA at investigator meetings, advisory boards, scientific conference etc.
- Advises the Senior MDD and Global Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions.
Core Remit of Activities External to Therapeutic Area Development (a
- As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects within the Rare Disease area
- Liaise with key internal experts to support pre-clinical programs including biomarker development
- 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)
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 degree (e.g., MD, MBChB or foreign equivalent)
- At least two years of pharmaceutical industry experience in clinical development with preference for rare disease drug development
- Clinical experience or board eligible/certification a plus
- Expertise in clinical development, pediatric clinical development and real-world evidence generation is highly preferred
- Understanding of US and European regulatory requirements and processes for product testing and approval
- Experience preparing for and presenting at US and European regulatory meetings such as Pre-IND, End-of-Phase 2, etc. preferred.
- In-depth knowledge of clinical protocol design, evaluation, and conduct
- Experience in the preparation and submissions of INDs, NDAs, and/or international registration dossiers
- Demonstrated ability to design and execute clinical development
- Experience in analyzing, interpreting, and reporting scientific results of clinical studies
Key Technical Competencies Required
- Objective-driven, solution and results oriented, with a solid sense of urgency
- Excels in working in matrix organizations and project teams
- Excellent priority setting, time management and organizational skills
- Excellent verbal, written, interpersonal communication skills
In order to maintain a safe work environment, Ipsen requires all employees to be fully vaccinated (with booster if eligible) against the Covid 19 virus at the time of employment.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.