(Senior) Clinical Program Lead

Vor 4 Tagen

Munich, Deutschland Boehringer Ingelheim Vollzeit

**(Senior) Clinical Program Lead**
**-**
**2214307**

**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**

The (Senior) Clinical Program Leader represents Medicine at the International Multidisciplinary Evidence Teams and you take clinical development responsibility for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, 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.

**Tasks & responsibilities**- You provide medical oversight to the clinical trial program within your respective project during protocol development, conduct, analysis and reporting, and you have responsibility for continuous benefit-risk assessment.-
- You also oversee medical project budgets for the respective project(s). Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards.-
- In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues.-
- You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary.-
- Furthermore, you review and approve publications within your project in collaboration associate Head of Medicine.As a Senior Clinical Program Leader, you:
- You author Investigator's Brochures, Asset Evidence Plans, Core Clinical Trial Protocols and Pediatric Development Plans together with your cross-functional project teams.-
- You also provide input to Project Analysis & Data Management Plans, Company Core Data Sheet, Annual Safety Report / IND (Investigational New Drug) Safety Reports.-
- Thanks to your expertise, you provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers and safety issues.-
- With your profound knowledge, 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**:
- MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry-
- Successful track record in planning, conduct and publication of Basic Science and/or Clinical Research-
- Sound medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams, regional BI counterparts and external partners-
- Previous contacts with regulatory authorities, international societies and other relevant international stakeholders-
- Good communication and presentation skills-
- Excellent cross-functional collaboration skills and ability to work in virtual teams-
- Full command of English languageThe Senior Clinical Program Leader role additionally requires:
- MD (specialist in Oncology or equivalent) with sound clinical oncology experience and multiple years of experience in the pharmaceutical industry-
- Profound clinical development experience as well as multiple years of experience in Pharmaceutical Industry in an international role. Former responsibility for international clinical development projects is also required**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 c

  • (Senior) Clinical Program Lead

    vor 7 Monaten

    Munich, 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 Therapeutic Area Inflammation from start of development through to registration. This may include definition of Target Product Profiles, design and execution of congruent,...

  • Senior Clinical Program Director

    vor 1 Monat

    Munich, Bayern, Deutschland Vality One Recruitment GmbH Vollzeit

    Job OverviewWe are seeking a highly experienced Senior Clinical Program Director to lead our clinical development programs. This is a unique opportunity for a seasoned professional to join a dynamic team and drive strategic growth.Job DescriptionDevelop and implement comprehensive global development plans, ensuring timely delivery of projects while...

  • Clinical Program Lead

    vor 2 Monaten

    Munich, Deutschland Vality One Recruitment GmbH Vollzeit

    Dein Aufgabengebiet Oversee the delivery of specific project functions, such as coordinating all program-related activities, managing budgets, and maintaining timelines. This includes close collaboration with the designated Program Operations Director for role support. Develop and manage the comprehensive Global Development Plan. Guide and motivate global...

  • Clinical Program Lead

    vor 2 Monaten

    Munich, Deutschland Vality One Recruitment GmbH Vollzeit

    Dein Aufgabengebiet Oversee the delivery of specific project functions, such as coordinating all program-related activities, managing budgets, and maintaining timelines. This includes close collaboration with the designated Program Operations Director for role support. Develop and manage the comprehensive Global Development Plan. Guide and motivate global...

  • (Senior) Principal Clinical Pharmacology Lead

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    This position can be filled in Ingelheim or Biberach **Tasks & responsibilities as Principal Clinical Pharmacologist**: - As Principal Clinical Pharmacology Lead, you will represent Clinical Pharmacology (Clin. Pharm.) in BI project teams as well as in internal or external initiatives or working groups.- You will provide input into clinical development...

  • Clinical Program Director

    vor 1 Monat

    Munich, Bayern, Deutschland Vality One Recruitment GmbH Vollzeit

    Key Responsibilities:Oversee the delivery of specific project functions, including coordinating program-related activities, managing budgets, and maintaining timelines through close collaboration with the Program Operations Director.Develop and manage the comprehensive Global Development Plan, ensuring alignment with organizational strategy.Guide and...

  • (Senior) Principal Clinical Imaging Lead

    vor 7 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Are you an expert in Translational Medicine and Lung Imaging? Do you have an interest in drug development, as well as knowledge and practical experience in the field of lung imaging technologies and image analysis? We are offering an exciting opportunity to join the global department Translational Medicine & Clinical Pharmacology (TMCP) at...

  • (Senior) Clinical Imaging Lead

    vor 7 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Are you an expert in Translational Medicine and Ophthalmic Imaging? Do you have an interest in drug development, as well as knowledge and practical experience in the field of ophthalmic imaging technologies and image analysis? We are offering an exciting opportunity to join the global department Translational Medicine & Clinical...

  • Program Lead

    vor 7 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **Tasks & responsibilities**: - Within the CTSM (Clinical Trial Supply Management) in CTSU (Clinical Trial Supply Unit) you take over the responsibility for global Supply Chain activities for Investigational Medicinal Products (IMPs) of national and international Phase I-IV clinical trials NBE projects.- In this role you act as the main point of contact to...

  • Senior Clinical Safety Scientist

    vor 6 Monaten

    Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...

  • Clinical Operations Leader

    Vor 3 Tagen

    Munich, Deutschland Proclinical Vollzeit

    Proclinical are recruiting a Clinical Operations Leader (COL) Europe for a CRO. This role is on a permanent basis with the ability to work remotely from anywhere in Europe. The client is focused on performing clinical trials for their pharmaceutical clients to accelerate the drug approval process. **Responsibilities**: - Supervise study deadlines, patient...

  • Clinical Trial Leader for Cmr

    Vor 3 Tagen

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    **Clinical Trial Leader for CMR** **-** **233665** **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...

  • Clinical Development Director

    vor 3 Wochen

    Munich, Bayern, Deutschland Vality One Recruitment GmbH Vollzeit

    Job OverviewWe are seeking a highly experienced Clinical Program Lead to join our team at Vality One Recruitment GmbH. In this role, you will oversee the delivery of specific project functions, manage budgets and timelines, and collaborate closely with cross-functional teams.

  • EMEA Security Program Manager Leader

    vor 4 Wochen

    Munich, Bayern, Deutschland Amazon TA Vollzeit

    Job OverviewAmazon Logistics and Amazon Partner Logistics are seeking an experienced Senior Program Manager to lead security programs in Europe, the Middle East, and Africa (EMEA). The successful candidate will be responsible for designing and implementing risk-based security solutions to prevent theft and losses.

  • Clinical Monitoring Associate Director

    vor 24 Stunden

    Munich, Deutschland Vertex Pharmaceuticals Vollzeit

    Job Description General Summary: The Clinical Monitoring Associate Director is responsible for ensuring on-time monitoring and quality delivery of all required work assignments within the Clinical Monitoring function. Responsible for clinical monitoring resourcing, training and quality oversight to ensure compliance with Good Clinical Practice and...

  • Clinical Director, Clinical Research

    vor 7 Monaten

    Munich, Deutschland MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we ‘follow the science’ and that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference...

  • Early Clinical Development Lead

    Vor 4 Tagen

    Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

    **Your Role**: - Member of the medical team, with key role leading the translation of therapeutic radiopharmaceuticals from the late preclinical stage of drug discovery to the design and execution of early clinical development (Phase I and Phase II) - Develop and lead the early clinical development plans for the assigned drugs - Lead the design of Phase...

  • Senior / Clinical Research Associate - Germany

    vor 7 Monaten

    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    **Senior/CRA - Germany (Remote)** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while...

  • Senior Clinical Research Associate

    vor 7 Monaten

    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    **Senior CRA - Germany** At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking...

  • Clinical Training Lead

    vor 2 Wochen

    Munich, Bayern, Deutschland MED-EL Vollzeit

    About MED-ELMED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss.Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide.With headquarters in Innsbruck, Austria, MED-EL has over 2,800 employees around the world.Job...