Clinical Development Director Contrast - Berlin, Deutschland - Bayer

Bayer

Geprüftes Unternehmen

Berlin, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Clinical Development Director Contrast & Digital Radiology Solutions (M/F/d)
The Global Clinical Lead (GCL) (M/F/d) is responsible for the ideation, strategic conceptualization, clinical design, conduct oversight, interpretation and reporting of results of clinical studies for the

YOUR TASKS AND RESPONSIBILITIES

Design, conduct, analysis, interpretation and reporting of clinical studies and other clinical documents related to the development of digital solutions and contrast media
Be responsible for the ongoing benefit/risk assessment of assigned assets, including the analyses of incoming clinical data during the conduct of clinical development studies, relevant medical and scientific information as well as aligning and initiating actions or decisions with other functions as appropriate
Be a core member of a multifunctional Global Project Team (GPT) and represent as clinical development lead function in other teams and committees as needed
Author clinical documentation for drug development purposes and regulatory interactions e.g. clinical development plan, clinical study protocols, clinical study protocol, clinical overviews and other regulatory submission documents, responses to requests for information
Author clinical documentation for digital development purposes and regulatory interactions e.g. Clinical Evauation Reports (CER) etc for 510k or DeNovo submissions, EU Medical Device Regulation (MDR),etc.
Lead clinical discussions with health authorities globally, as well as other external stakeholders
Support and collaborate with the global and regional Medical Affairs, Regulatory Affairs teams as well as other Bayer Radiology and PH functions, internal or external stakeholders and partners engaged in the development of Radiology assets

WHO YOU ARE

Doctor of Medicine degree (M.D.) with Board certification in a relevant therapeutic area (e.g. radiology, nuclear medicine, oncology)
Several years of experience in the development of pharmaceutical drug products within the health care pharmaceutical industry
Several years experience in the development of medical device and/or digital products e.g. artificial intelligence and machine learning based software as a medical device
Experience in regulatory environments especially in the EU, US, APAC is preferred
Demonstrated experience in producing clinical development documents (e.g. clinical study protocols and reports for contrast or other drug developments, regulatory submission modules, device CER and EU MDR clinical documents)
Proven track record of successful clinical leadership in drug, digital and device innovative development
Experience of effectively managing risk and compliance issues as well as managing diverse multifunctional teams across cultures and geographies
Proven leadership, motivational and interpersonal skills as well as the ability to provide clear vision, direction, and purpose in the different cultures present within a global R&D organization
Willingness to embrace change and to work in an agile and changing environment as well as accuracy, perseverance, creativity and the ability to work under pressure, both independently and cooperatively
Strong written and oral communication skills and high degree of fluency in written and verbal English

LI-DE

YOUR APPLICATION

This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change.

You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

Location:
Germany : Berlin : Berlin

Division:
Pharmaceuticals

Reference Code:788718