Easter Seals Jobs

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?

Please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330.

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.