Director, Clinical Pharmacology Lead (Remote)

• Responsible for defining the Clin Pharm strategy of assigned project in a timely manner.
• Serve as Clin Pharm representative within various project teams in support of early and late development teams for complex projects.
• Accountable and responsible for communicating with regulatory authorities on CP topics and for CP aspects of regulatory submission.
• Provide Clin Pharm input into clinical development plans, clinical study protocols and reports, Investigator's Brochures and the ClinPharm section of INDs, CTA's, NDAs/BLAs or respective label text.
• Act as Clin pharm representatives to various initiatives and working groups within BI and externally
• Train, provide consultancy and expert advice to trial clinical pharmacologist and junior clin pharm colleagues.
• Continuously and consistently develop, implement and promote innovative Clin Pharm methodologies/approaches to help ensure that work done in Clinical pharmacology group is consistent with the most current scientific understanding in the field.
• Ensure timely delivery of state-of-the-art Clin Pharm scientific concepts, data measurements and analyses for decision making throughout clinical drug development and registration for projects that represent new challenges (e.g. new modalities, indications etc.)

• Doctoral degree (MD or PhD) in Medicine, Pharmaceutics or Clinical Pharmacology preferably with 10 years relevant clinical pharmacology experience in the pharmaceutical industry, regulatory agencies, or academia preferred.
• Masters Degree in Medicine, Pharmaceutics, Clinical Pharmacology or equivalent area of focus with a preferably 10-15 years relevant experience in clinical pharmacology in the pharmaceutical industry, regulatory agencies, or academia could be considered for this position.
• Expert knowledge in clinical pharmacology, biopharmaceutics, clinical drug development and relevant regulatory guidelines. Recognized and respected as experts in clinical pharmacology internally and externally. Knowledge in pharmacokinetic software programs (e.g. Phoenix WNL), and graphic software packages (e.g. SigmaPlot). Good understanding of pharmacometric tools (modeling and simulation), their opportunities and limitations as well as a good understanding of statistical principals especially with respect to Clin Pharm trial data.
• Excellent communication and presentation skills. Highly independent, diligent and engaged. High emotional intelligence and leadership skills. A team player with very high analytical thinking.

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Boehringer Ingelheim