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 Pharmacology Lead (all genders) 

 

The incumbent for this position may be based in the United States (US) or several European countries. Bayer Talent Acquisition is accepting applications for these locations under one global job posting which follows each country's individual employment laws. As such, applicants should expect to experience differences in the application process which are unique from a single country posting.

The Clinical Pharmacology Lead (CPL) Oncology will bring an extensive experience and knowledge of the Clinical Pharmacology (CP) field for all phases of Oncology drug development projects.
This position will play a key role in management of interactions with KOLs as well as with regulatory authorities will work closely with PK specialists, Translational Sciences, Pharmacometrics, Research, Clinical Development, Regulatory, Medical Affairs and Commercial/Marketing functions. Ultimately, the position aims to optimize decisions on drug development projects (particularly the dosing strategy) and advance products to regulatory approval with a competitive and state-of-the-art product label

YOUR TASKS AND RESPONSIBILITIES

 

Build and execute an end-to-end clinical pharmacology (CP) strategy for all development programsComplete globally relevant CP activities from early research to Life Cycle Management (LCM) with cross-functional teamsDrive technical excellence and innovation within RED ONC through core projects and collaborationsRepresent Clinical Pharmacology (CP) Oncology in Product Teams (PTs) and related clinical teamsImplement CP and PK/PD aspects, including model-based development approaches for Oncology drug developmentDesign, plan, execute, and evaluate core CP studies, supporting Oncology Development and Global Medical Affairs (GMA) studiesLead and manage the preparation of CP sections for major clinical and regulatory documents and provide global CP submission supportIdentify new collaboration opportunities and manage relationships with partners to drive clinical pharmacology excellence

 

WHO YOU ARE

 

PhD, MD or PharmD with at long-term extensive expertise in the area of Clinical Pharmacology and Oncology Drug Development; of this, at least several years of experience must be in pharmaceutical industry or equivalent (e.g., FDA)Strong background and demonstrated expertise in Clinical Pharmacology, PK and PK/PD including model-based drug development as evidenced by major Regulatory submission experience (e.g. NDAs, CTDs, INDs), scientific publications and presentations at major meetingsIndustry experience in applications of Basic Research and/or Clinical Research with the ability to translate preclinical projects to the clinic.Proven ability to manage strategic, scientific and operational aspects of development projects from a Clinical Pharmacology perspective Evidence of leadership skills to direct and steer a team of experts, awareness of responsibility, efficient analytical thinking and working methodsCapable of working independently, excellent communication and organizational skillsAbility to handle conflict, highly resilientVery good knowledge of written and spoken English; command of a second major language is an asset

 

 

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.

 

 

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 race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
 

Location:           ​​ ​   Germany : Berlin : Berlin || Switzerland : Basel-City : Basel || United States : Massachusetts : Boston​

​​Division: ​               Pharmaceuticals​

Reference Code:  829514​