(Senior) Clinical Program Leader
vor 2 Wochen
**Tasks & Responsibilities**:
- In your new role, you are responsible for the design and preparation of late clinical development plans in the TA CardioMetabolism & Respiratory (CMR), and submission documents to prepare assets in one or more of the following areas: Obesity, Non-Alcoholic Steatohepatitis (NASH), Cardiovascular indications, and/or chronic kidney disease (CKD) for worldwide registration.- In alignment with the clinical development plans and as agreed with regulatory authorities (e.g. EMA and FDA), you conduct scientifically and clinically rigorous trials, contribute to relevant investigator's brochures and develop clinical trial protocols, amendments, modifications of clinical investigational plans, clinical trial reports and scientific publications.- You are responsible for trial start-up, trial conduct, data read out and submission to achieve registration for novel assets.- Furthermore, you work in close collaboration with Early Clinical Development team members, Medical Affairs and Market Access to ensure smooth transition of assets across various development phases.- With your expertise, you ensure a good understanding of the relevant customer groups for Obesity, NASH, Cardiology and/or CKD (health authorities, key external experts, associations, patient groups, payers, etc.).- You act as a decision maker in trial-related internal & external committee meetings, as delegated by the associate Head of Clinical Development CardioMetabolism.- Furthermore, you are an externally recognized expert in the field and represent Boehringer Ingelheim to experts, regulatory authorities and organizations.
- In cooperation with the Associate Head of Clinical Development CardioMetabolism, you exert medical and scientific leadership for cardiovascular indications within the TA CMR.
**Requirements**:
- MD with initial clinical and scientific experience in Medicine, preferably Endocrinology/Metabolism, Gastroenterology & Hepatology, Cardiology, Nephrology, or Internal Medicine; Clinical / Pharma experience in the US is a plus- Some years of experience in clinical drug development within pharma industry, or comparable clinical development experience in an academic setting- Solid regulatory knowledge and experience with various agencies like FDA and EMA- Excellent leadership communication (oral and written) as well as negotiation and influencing skills- Ability to act with grace and resilience under pressure as well as excellent presentation, training and facilitation skills
Additional Requirements for the Senior Role:
- MD with multiple years of clinical and scientific experience in Medicine, Endocrinology/Metabolism, Gastroenterology & Hepatology, Cardiology, Nephrology, or Internal Medicine; Clinical / Pharma experience in the US is a plus- Long-term experience in Clinical Drug Development in pharma industry and/or academia, preferably in an international role- In-depth regulatory expertise with prior successful interactions with various agencies like FDA and EMA- Excellent leadership communication (oral and written) as well as negotiation and influencing skills- Ability to act with grace and resilience under pressure as well as excellent presentation, training and facilitation skills
**Ready to contact us?**:
Please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330.
-
Clinical Program Lead
vor 2 Wochen
Frankfurt Am Main, Deutschland BI International GmbH Vollzeit**THE POSITION**: As (Senior) Clinical Program Leader you assume global responsibility and medical leadership for clinical development and evidence generation for assets in the indication area Gastroenterology/Crohn’s Disease from start of development through to registration. This may include definition of Target Product Profiles, design and execution of...
-
(Senior) Clinical Program Leader Oncology
vor 2 Wochen
Frankfurt am Main, Deutschland Haybury VollzeitMy client is a leading pharmaceutical company, who are looking for a Global Clinical Lead to join their team and drive the development of Oncology assets **As Global Clinical Lead you will**: - Contribute to Global Clinical Strategy - Author Clinical Development Plans, Clinical Protocols, TPP and design Clinical Studies - Interpret Clinical Data, with...
-
Senior Director, Compound Operation Lead
Vor 5 Tagen
Frankfurt am Main, Hessen, Deutschland Merck Healthcare Vollzeit 120.000 € - 200.000 € pro JahrWork Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
-
Senior Director
Vor 6 Tagen
Frankfurt, Deutschland Discover International VollzeitA fast-growing Biopharma CDMO is seeking an experienced Senior Director of Clinical Manufacturing to oversee all clinical-phase production activities at a specialised biologics facility in Germany. The site supports global biotech partners across Phase I–III programs, with capabilities spanning USP, DSP, aseptic filling, and viral/vector processing. This...
-
Clinical Operations Lead
Vor 6 Tagen
Frankfurt am Main, Deutschland Alimentiv Vollzeit**JOB TITLE**:Clinical Operations Lead **LOCATION**:Netherlands, Canada, US, Germany, UK or Romania (Home-based) **REPORTS TO**: Manager, Monitoring & Site Management (Europe & Asia Pacific) **DEPARTMENT/UNIT NAME**: Monitoring & Site Management **JOB SUMMARY**: Responsible for the clinical operations of a project within a defined regional/global level....
-
Senior Advisor Clinical Research
vor 2 Wochen
Frankfurt Am Main, Deutschland Eli Lilly VollzeitAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Clinical Trial Lead
vor 1 Woche
Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit 70.100 € - 100.000 € pro JahrThe IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with early phase clinical research projects (phase I and II) in different therapeutic areas. As...
-
Clinical Trial Lead
Vor 4 Tagen
Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit 70.100 € pro JahrThe IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client's project team to set-up and execute clinical trials. Joining the sponsor-dedicated team provides the opportunity to work with early phase clinical research projects (phase I and II) in different therapeutic areas. As...
-
Senior Program Manager
vor 1 Tag
Frankfurt am Main, Hessen, Deutschland Equinix Vollzeit 85.000 € - 110.000 € pro JahrWho are we? Equinix is the world's digital infrastructure company, shortening the path to connectivity to enable the innovations that enrich our work, life and planet. A place where bold ideas are welcomed, human connection is valued, and everyone has the opportunity to shape their future.A career at Equinix means being at the center of shaping what comes...
-
Senior Advisor Clinical Research
Vor 5 Tagen
Frankfurt Am Main, Deutschland Lilly VollzeitAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
