Clinical Program Lead

vor 3 Wochen

Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

**THE POSITION**:
As (Senior) Clinical Program Leader you assume global responsibility and medical leadership for clinical development and evidence generation for assets in the indication area Gastroenterology/Crohn’s Disease from start of development through to registration. This may include definition of Target Product Profiles, design and execution of congruent, competitive, fast-to-patient Clinical Development Plans, Paediatric Investigational Plan, Medical Narrative, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, Release of Submission.

This position can be filled in Germany or USA.

***Tasks & responsibilities**:
- You are accountable for the strategic planning, oversight and execution of the program, including the continuous monitoring of the risk-benefit ratio of the clinical development project.- With your expertise and scientific insight, you provide the necessary medical contribution to clinical trial protocols and prepare relevant documentation for the submission to Regulatory Agencies.- You also oversee medical project budgets for the respective project(s). You serve as a key member of the cross-functional Early Clinical Integration/Evidence Integration Team dependent on project stage and you represent the medical team in the governance/committee interactions. With your profound disease area expertise, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards.- In your new role you are leading the Evidence Integration team and you will develop and execute the wholistic asset evidence generation strategy to demonstrate competitive value of an asset throughout the life cycle in close collaboration with the Drug/Device and Value Network.

Additional for the Senior CPL role:
- You may assume medical leadership of multiple clinical development projects, with oversight across multiple indications.- Depending on your seniority you may coach other Clinical Program Leaders within the therapeutic area.- Act as the key medical point of contact for internal and external stakeholders including providing medical leadership to the cross-functional teams involved in the clinical trial programs within Boehringer Ingelheim.- You maintain an external focus to ensure a good understanding of the relevant customer groups for your designated asset(s), e.g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/steering committees, adjudication committees and Safety Data Monitoring boards for your projects.

***Requirements**:
- Medical degree or PhD with clinical drug development expertise and knowledge of Crohn’s disease- Successful track record in planning, conduct and publication of Basic Science and/or Clinical Research- Good project management and excellent cross functional collaboration skills with ability to work with global matrix teams- Agile and effective working style in a fast-paced and changing environment- Fluent in English with very good communication and presentation competencies- Willing to travel and work in a global environment

Additional Requirements for the Senior role:
- Long-term experience in the pharmaceutical/CRO industry preferably in an international role in pulmonology clinical research- Previous experience of leading clinical development programs with Novel Therapeutic Concepts and/or First in Class compounds- Previous experience of engaging with major Regulatory Health Authorities, KOLs in the field of respiratory drug development- Excellent communication and presentation competencies, with proven ability to lead international cross-functional matrix Teams

***READY TO CONTACT US?**:
Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173

  • Senior Clinical Program Lead

    vor 1 Monat

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: Are you a passionate and experienced Retinal Specialist looking to take your career to the next level? Do you want to be at the forefront of clinical research and development, driving patient value and quality of life outcomes? If so, we have an exciting opportunity for you! Boehringer Ingelheim is seeking a dedicated and innovative...

  • (Senior) Principal Clinical Pharmacology Lead

    vor 1 Monat

    Ingelheim am Rhein, Deutschland Boehringer Ingelheim Vollzeit

    THE POSITIONAs Clinical Pharmacology Lead you act in global development teams with a responsibility for the Clinical Pharmacology development package.You work in a department (Translational Medicine & Clinical Pharmacology) bridging the path from early research to submission interacting with multiple functional areas within BI. You have the choice to work at...

  • Project Management Associate

    vor 3 Stunden

    Frankfurt am Main, Deutschland Advanced Clinical Global Vollzeit

    Overview: The Project Management Associate will support the Project Manager or Program Director to ensure contracted services are carried out as required. The Project Management Associate will help support the Project Manager or Program Director to oversee all assigned clinical research staff to ensure that efficient and effective management of clinical...

  • Asset Lead

    vor 1 Monat

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: As an Asset Lead at Boehringer Ingelheim, you will be part of a committed and passionate global team. We are dedicated to delivering innovative therapeutic solutions with the patient at the heart of everything we do. Our culture fosters innovative thinking, agility, and collaboration. We are inviting you to bring your talent and experience...

  • Clinical Research Associate

    vor 4 Wochen

    Frankfurt am Main, Deutschland Warman O'Brien Vollzeit

    **Clinical Research Associate - World Leading CRO - Permanent** We are seeking an experienced Clinical Research Associate to take on an exciting opportunity with an international CRO that is continuing to lead from the front in the industry. Utilising their unique experience and global reach, this CRO has regularly demonstrated why they are market leaders...

  • Clinical Research Associate

    Vor 4 Tagen

    Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

    When you join IQVIA as a sponsor-dedicated Clinical Research Associate / CRA (m/w/d)home-based throughout Germany , you'll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients. Whether you're just starting out or looking to deepen your expertise, this role promises to...

  • Clinical Research Coordinator A/b/c

    vor 1 Monat

    Frankfurt Am Main, Deutschland University of Pennsylvania Vollzeit

    University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities...

  • Clinical Research Assistant a

    vor 1 Monat

    Frankfurt Am Main, Deutschland University of Pennsylvania Vollzeit

    University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities...

  • Senior Clinical Manager

    vor 1 Monat

    Frankfurt, Deutschland elemed Vollzeit

    Title: Global Clinical Operations Manager Location: Remote anywhere in Germany (with travel)✉️ Contact: frankie@elemed.eu The companyHere is a rare and great opportunity to join an international manufacturer in surgical devices and be part of this company’s new digitalized Clinical & Medical Affairs processes. You will be reporting directly to...

  • Commercial Vehicle Driving Program Lead Instructor

    Vor 5 Tagen

    Frankfurt am Main, Deutschland Tallahassee Community College Vollzeit

    MAJOR FUNCTION :  The Commercial Vehicle Driving Full-time Instructor is a position housed at the Transportation and Logistics Center of Excellence near TCC’s main campus. The Instructor’s major function is to collaboratively lead the Commercial Vehicle Driving Program, creating an ideal learning environment, maintaining an appropriate balance of...

  • Clinical Project Manager

    vor 1 Woche

    Frankfurt am Main, Deutschland Ascom Vollzeit

    March 15, 2024 Are you passionate about making a real difference in healthcare through innovative technology solutions? Ascom, a leading global provider of Healthcare ICT and mobile workflow solutions, invites you to be part of our dynamic team. With a rich legacy spanning 160 years and operations in 19 countries, Ascom is dedicated to empowering...

  • Pharmacovigilance Specialist

    vor 1 Monat

    Frankfurt am Main, Deutschland Syneos Health Clinical Vollzeit

    **Overview** **Base location: Neu-Isenburg** **Regions covered: Germany** The Global Safety Regions Specialist (GSRS) will follow the strategic direction for Global Safety Regions while establishing and maintaining it globally. The GSRS will also maintain the locally needed standardised practices to ensure compliance with international and national...

  • Clinical Research Associate or Senior CRA

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

    We are looking for an experienced CRA or Senior CRA (m/w/d) for a sponsor dedicated role in cooperation with Boehringer Ingelheim , one of the largest and most established pharmaceutical companies in Germany (family owned since 1885), with focus on therapeutic areas such as Pulmonology, Oncology and Neurology.When you join the IQVIA sponsor-dedicated cFSP...

  • Field Clinical Specialist Graduate-Germany Frankfurt

    Vor 5 Tagen

    Frankfurt am Main, Deutschland Boston Scientific Vollzeit

    Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth   At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most...

  • Principal Statistical Programmer

    Vor 3 Tagen

    Frankfurt am Main, Deutschland Novasyte Vollzeit

    IQVIA is looking to appoint statistical programmers at Principal level to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home...

  • Senior Director

    vor 2 Wochen

    Frankfurt, Deutschland Proclinical Vollzeit

    Proclinical is seeking a dedicated Senior Director for Clinical Trial Supply Management (CTSM) with a focus on Cell & Gene Therapies. The successful candidate will lead initiatives for all global CTSM activities in the Cell & Gene portfolio, supporting the development of future commercial launches. This role is crucial in delivering performance in the right...

  • Senior Director

    vor 2 Wochen

    Frankfurt, Deutschland Proclinical Staffing Vollzeit

    Proclinical is seeking a dedicated Senior Director for Clinical Trial Supply Management (CTSM) with a focus on Cell & Gene Therapies. The successful candidate will lead initiatives for all global CTSM activities in the Cell & Gene portfolio, supporting the development of future commercial launches. This role is crucial in delivering performance in the right...

  • Team Lead Medical Affairs Oncology

    vor 1 Woche

    Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **The Position**: Are you passionate about making a difference in the field of oncology? Do you thrive in a dynamic environment where you can lead and inspire others? Look no further! As the Team Lead Global Medical Affairs Oncology, you’ll play a pivotal role in shaping the launch strategy for our groundbreaking oncology therapies. Your expertise will...

  • Director of Customer Program Management- VW Group

    Vor 2 Tagen

    Frankfurt am Main, Deutschland HERE Technologies Vollzeit

    What's the role? As the Director of Customer Program Management- VW Group (Delivery Lead) , you will play a pivotal role in overseeing the successful delivery of our programs and services to our valued customer. You will be responsible for leading a Customer Program Management matrix organization including Program Managers, Technical Project...

  • Clinical Operations Administrator

    vor 1 Monat

    Frankfurt am Main, Deutschland Arcondis Vollzeit

    ABOUT ARCONDIS Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and...