Medical Lead in Clinical Research (m/f/d)

Dr. Falk Pharma GmbH
Freiburg

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Details zur Stelle

Leistungen

Mentoring-Programm für Mitarbeiter
Firmenfahrrad-Leasing
Flexible Arbeitszeiten

Qualifikationen

Microsoft Office
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Your tasks

Serves as medical lead (ML) for the company-sponsored clinical trials and development programs. Responsible for guiding the clinical development strategy and ensuring the scientific integrity of clinical trials. ML collaborates with Clinical Research teams and serves as a key liaison between Clinical Research and Global Safety teams. ML manages all medical aspects of clinical trials and contributes to the development of trial documents. ML drives execution for assigned projects in collaboration with Clinical Research teams and other cross-functional stakeholders.

Key Responsibilities

Provides medical input to Clinical Trial Protocol, Investigator’s Brochure, Informed Consent Form, Independent Data Monitoring Committee Charter, Statistical Analysis Plan, Medical Monitoring Plan, Clinical Trial Report, Clinical Trial Overview Statements and other clinical trial documents
Provides medical risk assessment for activities related to clinical trials and development programs
Performs oversight for clinical trial medical monitoring activities outsourced to CROs
Point of contact for sites and clinical trial teams with medical questions
Point of contact for questions on Clinical Trial Protocol with regard to inclusion and exclusion criteria, concomitant medications
Collaborates with various departments, including Global Medical Affairs and Global Safety/Pharmacovigilance to provide medical input for the development of patient-centric benefit-risk profile assessment strategies for developmental compounds
Supports data analysis and interpretation of collected data to assess the efficacy and safety of the compound/intervention, including statistical evaluation and comparison to predefined endpoints
Interprets clinical trial medical data for Clinical Trial Reports and submission documents
Supports final report preparation including compiling findings into a comprehensive Clinical Trial Report that outlines the methodology, results and conclusions of a clinical trial and which will be used for regulatory submissions
Reviewer of regulatory submissions based on clinical trial results with focus on efficacy, including preparing and submitting necessary documentation to regulatory authorities, such as the FDA or EMA
Supports Global Safety with medical expertise in the review of adverse events and safety issues, as requested
Provides support in the review of scientific publications (abstracts, presentations, and manuscripts)
Supports review of concepts for investigator-initiated studies
Contributes to company-internal process improvement initiatives (e.g. SOP updates)

Your qualification

Physician / medical license holder
A minimum of 5 years of clinical development research, 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.
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
Proficiency in standard MS Office applications
Excellent written and oral communication skills
Proficient in English, advanced knowledge in German
Ideally you should be willing to work at least 1 day/week in our Freiburg office. However, the position can also be fullfilled hybrid, with periodic meeting attendance at Dr. Falk Pharma GmbH Freiburg office (frequency to be agreed)

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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Your tasks

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