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(Senior) Clinical Program Leader - CMR

(Senior) Clinical Program Leader - CMR-212097  


At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


We at Boehringer Ingelheim Medicine share one vision: to turn patient-focused innovations into life-changing treatments. We focus on driving medical innovation, combining scientific and patient insights to develop and deliver safe and effective solutions. By concentrating on first-in-class innovations, we aim to set new standards for patient care now and for years to come.

We build on the strongest of all our assets: Our people. We are an agile team with diverse skills, always striving for excellence. We embrace new technologies and trends, make use of broad data and leading analytics. Our professional ethos reflects our personal values. Above all, we are united by our passion for improving healthcare and the enduring commitment to delivering valuable solutions that transform lives today, tomorrow and beyond.

This role can either be filled in Germany or in the US.

Tasks & Responsibilities

* In your new role, you are responsible for the design and preparation of late clinical development plans, pivotal Phase 3 studies, and submission documents to prepare assets for Obesity, Non-Alcoholic SteatoHepatitis (NASH), 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 set-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, 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, 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, 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 EMAExcellent 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



We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.


This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area. 

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin. 


Please contact our Recruiting EMEA Team, Tel: +49 6132 77 173173

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## Job

 - Medicine / Regulatory Affairs

## Primary Location

 - Europe-DE-Rhineland-Palatinate-Ingelheim

## Organization

 - DE-BI International GmbH

## Schedule

 - Full-time

(Senior) Clinical Program Leader - CMR

Boehringer Ingelheim GmbH
Ingelheim am Rhein

Veröffentlicht am 02.07.2021

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