Director Early Clinical Trials/Early Clinical Development Operations Expert

Employer
Boehringer Ingelheim
Location
Ingelheim, Germany
Salary
Competitive
Start date
18 Jan 2023
Closing date
17 Feb 2023

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


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.


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/trends in the market.
  • Commitment to high ethical standards and desire to transform lives of patients with unmet needs.
  • Leadership mindset with ability to lead by example.
  • Ability to effectively set direction, innovate, and communicate in a global ecosystem with cross-functional internal and external stakeholders.
  • Proven ability to build internal relationship and exert influence in a matrix and virtual environment and external relationship with thought leaders, industry bodies, etc.
  • Ability to create a culture of collaboration and being able to reach out beyond organizational boundaries for constructive solution finding.
  • Capability to drive decision making with organizational flexibility across Global TAs, Corporate Medicine and Global Regions.
  • Ability to engage with customers, building strong customer relationships and delivering customer-centric solutions.
  • Capability to effectively build and manage relationships with many different (internal & external) stakeholders, engaging with them in a planned and meaningful way in pursuit of the company’s strategic objectives.



WHY BOEHRINGER INGELHEIM?


This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area .

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.


READY TO CONTACT US?


Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173

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Company

With 47,700 employees in 103 countries, Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Since its foundation in 1885, the family-owned company has been pursuing an ambitious goal: to research and develop innovative pharmaceuticals that improve the health and quality of life of humans and animals alike

Find Us
Website
Location
Binger Straße 173
Ingelheim am Rhein
55216
DE
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