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Early Clinical Lead (all genders)
As ECL, you lead the early clinical team responsible for the early clinical development of drug candidates (until Proof of Concept/PoC)
Accountable and responsible for coordinating the design, execution and delivery of the early clinical development plan, through PoC as well as the clinical pharmacology plan in partnership with other functions and the Global Clinical Lead (GCL), with input from and consensus with other groups e.g. Research Groups, Early Development, Regulatory Affairs and commercial functions
Work as an internal expert opinion in Target ID teams or early research teams, providing medical/ clinical expertise in order to identify and assess intended indications, patient(sub)populations and drug targets within the global Bayer strategic frames
Starting during early preclinical research, you provide early clinical development concepts or plans for the respective milestones and starting prior to PCC, he/she ensures definition of an early clinical development and related clinical pharmacology plan, their milestones and, in particular, go/no go decisions and PoC deliverables which fits to the overall therapeutic area strategy
Ensure the appropriate inclusion of biomarkers and new clinical methodology/technology in close liaise with partner functions such as Translational Sciences
Provides the medical/clinical assessment justifying the First-in-Man application for approval by the Joint FiM/Tox Release Conference; responsible for the ongoing benefit/risk assessment from FiM until PoC, based on the thorough clinical understanding of the targeted indication and the medical need, the medical/clinical interpretation of study data, and additional relevant medical and scientific information
Provide input, final review as well as the clinical approval for clinical documents: e.g. study protocols, investigator brochures (IBs), study reports, statistical analysis plans, publications, clinical sections of IND/CTA submissions
Provides medical/clinical assessment of in- and out-licensing opportunities of research and development projects
WAS SIE MITBRINGEN
M.D. with long term relevant professional and academic experience
Long-term experience in clinical drug development and/or a relevant therapeutic specialty and/ or in clinical pharmacology
Strong track record of designing, executing and delivering excellent, focused clinical development plans and clinical studies to produce both timely and good quality data
Several years of experience in successful leading and managing cross-functional teams
Strong track record of achievement and innovation in pharmaceutical medicine: demonstrated understanding of the complexities and recent developments in the medical area(s) germane to the TA; understanding of issues related to the design and performance of technologically demanding trials; confident discussing scientific/mechanistic aspects of drug development; demonstrated ability to present clinical data, development plans and strategies clearly and accurately to relevant audiences
Excellent communication, networking, negotiation and collaboration skills to engage all involved stakeholders across all levels, ability to drive & influence decision making across all levels of the organization, strong stakeholder management capabilities as well as strong network outside of Bayer
Ability to constantly challenge existing paradigms in clinical research and encourage use of breakthrough designs based on an understanding of clinical methods, biomarkers and new technologies (including PK/PD modelling and simulation, physiological measurements, imaging, and biochemical/drug assays)
Fluency in English is essential; command of a second major European language, ideally German
This position represents several equivalent positions that can be filled.
Listed below are aspects of the application process which may be present to maintain job posting compliance in the multiple countries which this position is posted.
United States:
In some states, US job postings are required by law to include the salary range. If the work location of the position is in a state which has pay transparency laws in place or is posted to US residence-based, applicants will see salary information in the job description.
The US Food and Drug Administration prohibits anyone who has been convicted of a crime relating to a drug product to work in the pharmaceutical industry. For this reason, all job postings where the work location includes the US will require applicants to disclose if they have ever been debarred by the FDA. Applicants not applying for US employment will be given the option to answer this is not applicable.
Germany:
All applicants who apply to a posting which can be located in Germany, are given the option to disclose if they have a severe disability as certified by Germany authorities. This is a voluntary question and applicants are given the option to answer as not applicable if they prefer not to disclose.
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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.Bayer welcomes applications from all individuals, regardless of national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, orientation, gender identity, gender expression or any criterion under applicable law. We are committed to treating all applicants fairly and avoiding Location: Germany : Berlin : Berlin || Germany : North Rhine Westfalia : Wuppertal-Aprath || Switzerland : Basel-City : Basel || United States : Massachusetts : Boston
Division: PharmaceuticalsReference Code: 820550
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