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Clinical Research - Head of Gastroenterology II (m/f/d)

Dr. Falk Pharma GmbH
Freiburg

Jetzt bewerben

Details zur Stelle

Leistungen

Mentoring-Programm für Mitarbeiter
Firmenfahrrad-Leasing
Flexible Arbeitszeiten

Qualifikationen

Management-Erfahrung
Forschungserfahrung
Microsoft Office
Projektmanagement
Klinische Studien
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Your tasks

Serves as group lead (GL) for the company-sponsored clinical trials and development programs in the therapeutic area of functional gastrointestinal and gastrointestinal motility disorders. Responsible for guiding the clinical development strategy and ensuring the scientific integrity of clinical trials within this therapeutic area. GL collaborates with Clinical Research teams from other therapeutic areas and serves as a key liaison between Clinical Research Gastroenterology II, Global Safety, Pre- and Early Clinical Research, and Regulatory and Medical Affairs. GL drives execution for assigned projects in collaboration with other cross-functional stakeholders.

Key Responsibilities

Line manager for the organization/project management of clinical studies in the Gastro II department
Transfer of project responsibilities to assigned employees
Review and approval of critical development documents (e.g., Clinical Trial Protocol, master ICF, Statistical Analysis Plan, Clinical Trial Protocol)
Review and negotiation of study budgets with service providers (e.g., CRO, central laboratory)
Review and approval of investigator and vendor contracts (e.g., CRO, central laboratory)
Regular meetings within the Gastro II department (Clinical Operations)
Monthly reporting to the Head of Clinical Research
Support for the Head of Clinical Research in preparing and updating clinical development plans
Cross-functional support in the clinical assessment of research and/or study proposals, development offers, and Go/No-Go decisions in clinical development
Organization of and participation in Steering Committee meetings with development partners
Participation in new patent applications
Preparation of cross-functional presentations for senior management (e.g., deep dives, global program updates, phase transitions)
Participation in reviewing the clinical sections of regulatory submission dossiers, documents for scientific consultations (e.g., Scientific Advice, PIP, benefit dossier, etc.), or orphan drug applications in consultation with the Head of Clinical Research
Participation in coordinating and drafting responses to clinical deficiency letters in regulatory procedures in consultation with the Head of Clinical Research
Participation in the creation and revision of SOPs in the field of Clinical Research
Attendance at national and international congresses in the field of gastroenterology/hepatology
Maintaining contact with clinical key opinion leaders in gastroenterology/hepatology

Your qualification

Completed medical, scientific, or pharmaceutical degree
A minimum of 5 years of clinical development research and clinical study project management, or related clinical research experience within the industry (pharmaceutical, biotech, CRO) at an international (Europe, USA, Australia) level is required
Knowledge in clinical development in gastroenterology and/or hepatology is beneficial
Significant experience with clinical evaluation projects including the development of Clinical Trial Protocols, case report forms, Informed Consent Forms and Investigator Brochures.
Solid knowledge of regulatory requirements for conducting clinical trials
Several years of management experience
Proactive team player, results-oriented, and striving to find optimal solutions in a collaborative team environment
Self-organized, self-motivated, and able to work independently
Excellent written and oral communication skills
Proficient in English and German
Proficiency in standard MS Office applications
Ideally you should be willing to work at least 2-3 day/week in our Freiburg office

Your benefits

Supportive, respectful and appreciative work atmosphere in a small, dedicated team
Diverse learning culture and individual development opportunities
International and growing family business with short decision-making processes, financial independence and long-term perspective
New work, flexible working hours and mobile working
Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
Comprehensive onboarding and mentoring program

If you have any questions, please do not hesitate to contact Sabine Aicher at [email protected] or call 0761 1514-253. We look forward to receiving your application via our online portal.

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Erweiterte Suche

lead of safety Jobs in freiburg, bw

Clinical Research - Head of Gastroenterology II (m/f/d)

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