(Senior) Clinical Program Leader CRM
Boehringer Ingelheim
**The Position**
**This position can be filled in different countries.**
If you want to apply for the position in USA, please use this link: https://jobs.boehringer-ingelheim.com/job-invite/20965/
If you want to apply for the position in “Germany Biberach or Ingelheim click " **Apply now** ".
**Tasks & responsibilities**
In your new role, you are responsible for the design and preparation of late clinical development plans in the TA CardioMetabolism & Respiratory (CMR), and submission documents to prepare assets in one or more of the following areas: Obesity, Non-Alcoholic Steatohepatitis (NASH), Cardiovascular indications, 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 start-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, Cardiology 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, Cardiology, 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, Cardiology, 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 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
**Ready to contact us?**
If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com
Recruitment process:
Step 1: Online application - application deadline is April 7th.
Step 2: Virtual meeting in the from mid of April.
Step 3: On-site interviews beginning of end of April.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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