(Senior) Clinical Program Lead NASH/CMR

OUR COMPANY 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. THE POSITION 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 early clinical development plans, phase Ib and II, mechanistic and non-interventional studies and submission documents for assets in NASH. 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, clinical trial reports and scientific publications. You are responsible for trial set-up, trial conduct, data read out and reporting to achieve proof of clinical concept.

Apart from that, you provide medical expertise to research and licensing opportunities in the field of NASH. You work in close collaboration with Research, Translational Medicine and Clinical Pharmacology (TMCP), Clinical Operations, late-stage Clinical Development, early Medical Affairs and Market. Access team members to ensure smooth transition of assets across various development phases.

Maintain an external focus to ensure a good understanding of the relevant customer groups for NASH (Health Authorities, Key External Experts, Associations, Patient groups, Payers etc.). Act as a presenter and decision maker in NASH-related internal & external committee meetings, as delegated by the associate Head of Pipeline Clinical Development CardioMetabolism.

Furthermore, you are an externally recognized expert in the field of NASH/Metabolism and represent Boehringer Ingelheim to experts, regulatory authorities and organizations. In cooperation with the Associate Head of Pipeline Clinical Development CardioMetabolism, you exert medical and scientific leadership for NASH within the TA CMR. Requirements MD, sound clinical and scientific experience in NASH and Metabolism of at least several years; 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, sound clinical and scientific experience in NASH and Metabolism of many years; 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 knowledge 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 EFFECTS OF COVID-19 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. WHY BOEHRINGER INGELHEIM?

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 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. READY TO CONTACT US? Please contact our Recruiting EMEA Team: Rosa Trapiella, Tel: 49 (6132) 77-172529 Not exactly the position you are looking for but have someone else in mind?

Share it via the button on the bottom of the page with friends or colleagues who might be interested.