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