The Position Reporting to the Global Head of Early Clinical Trials, the Director, Early Clinical Development Operations Expert (eCDOE) is a critical new role that is accountable for both strategic as well as operational clinical program execution excellence in the Early Clinical Trial (ECT) team. The eCDOE is responsible for the oversight of a set of clinical programs in an Oncology focus area (Area Lead Role) as well as for the planning and execution of high-priority clinical programs in the Oncology portfolio (Program Level Role) prior to Start of Development (SoD) until Proof of Clinical Concept (PoCP).
In the Area Lead Role, the eCDOE will contribute expert knowledge to a set of clinical programs conducted by ECT colleagues and will be instrumental in building an ECT team culture of learning, innovation and drug development excellence. In the Program Level Role, the eCDOE is a critical member of the early clinical integration team that oversees the asset strategy from SoD to PoCP. The eCDOE contributes expert knowledge in clinical pharmacology, trial design, benefit/risk assessment and early clinical development & operations to the programs. The eCDOE further provides early clinical development strategic recommendations to the assigned Therapeutic Areas within the Clinical Development and Operations (CD&O) organization (TA Head Medicine CD&O) to drive clinical development speed and patient value.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of the company's products to patients and customers. The company's global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company's success.
This position can be filled in Ingelheim or Biberach.
Tasks & responsibilities - Drives strategic and operational clinical program execution across development programs as an Area Lead in Oncology and for high-priority assets on the program level, all based on expertise from clinical practice, a science background and drug development experience.
- Champions an ECT culture as a role model for learning, innovation and drug development excellence
- Integrates preclinical information and interprets its implications for clinical development including the requirement of specific clinical pharmacology data to support PoCP and contributes to the interaction with Health Authorities before start of late phase programs
- Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset/s in Oncology
- Accountable for execution of pharmacodynamic and pharmacokinetic studies/programs to generate evidence for PoCP and potentially End of Phase II meeting with Health Authorities.
- Advises early integration team/asset evidence team on program/trial design innovation in early clinical trials and clinical program execution excellence scenarios.
- Closely collaborates with other functions to ensure a smooth compound transition from R&D into early clinical trials.
- Ensures timely execution excellence input into various documents, including asset evidence plan and clinical trial protocols.
- Accountable for companion device/biomarker development execution strategy in early clinical development, if applicable, and leverages digital innovation to drive Medicine Excellence goals.
- Responsible for utilizing data, technology, and input from external stakeholders (patient groups and potential investigators) to determine realistic timelines, identify feasibility issues, roadblocks, supplier needs, external committees and expert mapping for the clinical trials.
- In close association with Head of CD&O TA Oncology, develops phase I collaboration with external phase I units, academic community, and specialized vendors.
- Jointly accountable with the other members of the early clinical integration team to live Boehringer Ingelheim's cultural values of winning spirit, empowerment and smart risk taking to drive Medicine Excellence goals.
Requirements - Medical Degree with longterm experience in relevant basic science research field, clinical practice, and early clinical drug development.
- Expert content knowledge in Oncology
- Excellent medical and scientific understanding of the Oncology space, including general understanding of Pharma industry, rules, and regulations.
- Proven track record on developing and executing early clinical development plans focusing on the transition from R&D to clinical development until PoCP with focus a on Oncology in a x-functional matrix team.
- In-depth knowledge of the strategy of competitors and of developments/tre