Senior Clinical Program Lead

vor 2 Wochen

Munich, Deutschland BI International GmbH Vollzeit

**The Position**:
As (Senior) Clinical Program Lead (CPL) you assume full medico-scientific and strategic leadership of global clinical development programs and evidence generation for assets in the indication area Pulmonology/pulmonary fibrosis with the objective to accelerate clinical development and achieve regulatory approvals and reimbursable medicines. As CPL you may assume the responsibility of an Evidence Lead in the Asset Teams, leading the creation and execution of a holistic evidence generation strategy and integrating the deliverables of all medical functions as the leader of the Evidence team. You will drive patient value, patient voice and quality of life & outcomes in line

with Medicine Excellence goals.

***Tasks & responsibilities**:
- In your new role, you are accountable for the development and execution of clinical development strategy for designated programs as part of a broader Integrated Asset Evidence Strategy, in alignment with the TPP and in consultation with your supervisor(aHOM) while ensuring integration of regional input.- You will author Investigator Brochures (with support from the Medical Writer and other contributors), Clinical Development Plans/Asset Evidence Plans, Core Clinical Trial Protocols, including the CTP strategy and core CTP elements within a document such as Trial Design- Synopsis and Pediatric Development Plans, and respective sections of regulatory documentation (CCDS, submission package, and health authority briefing documentation).- With your expertise and scientific insight, you provide input to regulatory strategy (or, in the role as Evidence lead, oversee regulatory strategy) and lead clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses.- You also oversee medical project budgets for the respective project(s) and serve as a key member of the cross-functionalAsset Team and Evidence (Integration) Team dependent on project stage and you represent the medical team in the governance/committee interactions, e.g., in preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, Release of Submission.

Additional for the Senior CPL role:
- You may assume medical leadership of multiple clinical development projects, with oversight across multiple indications.- As a mentor you will 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 will lead authoring of clinical abstracts, congress presentations and manuscripts (as appropriate).- Therefore, you review and approve publications within your project(s) in collaboration with the (A)HoM.- 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 (preferred) or PhD with profound clinical development experience in thje field of pulmonology- Experience in clinical development of investigational compounds and in all relevant aspects of clinical research. Experience in drug development in the field of pulmonary fibrosis is highly desirable- 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- Willing to travel and work in a global environment- Fluent in English with very good communication and presentation competencies

Additional Requirements for the Senior role:
- Long-term experience in the pharmaceutical 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 HR Direct Team, Tel: +49 (0) 6132 77-3330

  • (Senior) Principal Clinical Pharmacology Lead

    Vor 3 Tagen

    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...

  • Senior Medical Director Clinical Development

    Gefunden in: beBee S DE - vor 2 Wochen

    Munich, Deutschland Proclinical Vollzeit

    Proclinical is seeking a dedicated and experienced Senior Medical Director for Clinical Development. The successful candidate will be responsible for the medical monitoring of assigned clinical development programs and the strategy and implementation of one or more clinical development programs. This role involves working closely with external experts and...

  • Senior Medical Director Clinical Development

    Gefunden in: beBee jobs DE - Vor 7 Tagen

    Munich, Bayern, Deutschland Proclinical Vollzeit

    Proclinical is seeking a dedicated and experienced Senior Medical Director for Clinical Development. The successful candidate will be responsible for the medical monitoring of assigned clinical development programs and the strategy and implementation of one or more clinical development programs. This role involves working closely with external experts and...

  • Senior Clinical Safety Scientist

    Vor 4 Tagen

    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...

  • Senior Clinical Data Manager

    Gefunden in: Talent DE C2 - vor 1 Woche

    Munich, Deutschland Fortrea Vollzeit

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Senior Clinical Safety Scientist

    Gefunden in: Talent DE C2 - Vor 4 Tagen

    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...

  • Asset and Program Lead

    Gefunden in: Talent DE 2A C2 - vor 1 Woche

    Munich Metropolitan Area, Deutschland ageneo Life Science Experts (Interim Solutions) GmbH Vollzeit

    DAS UNTERNEHMENFür ein innovatives clinical-stage Biotechunternehmen sind wir auf der Suche nach einem Asset & Program Lead (gn). In dieser Funktion übernehmen Sie die übergeordnete Verantwortung für ein Lead-Projekt des Unternehmens und koordinieren alle relevanten Entwicklungs- und Pre-Registration Maßnahmen für das Asset. IHRE AUFGABENSie...

  • Clinical Sales Representative

    Gefunden in: beBee S DE - vor 4 Wochen

    Munich, Deutschland Intuitive Surgical Vollzeit

    Job DescriptionPrimary Function of Position:A da Vinci Clinical Sales Representative is responsible for maximizing the utilization of installed da Vinci® Surgical System.Roles and Responsibilities:Work with the da Vinci Clinical Sales Manager to develop a sales plan for the local market.Become a clinical expert across all primary OR procedures to position...

  • VP Clinical Development

    Gefunden in: beBee S DE - vor 3 Wochen

    Munich, Deutschland Proclinical Vollzeit

    Proclinical are recruiting for a VP Clinical Development (m/w/d) to join a biotech organisation. This role is on a permanent basis and is located in Munich.Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance. Responsibilities:For this role, you will guide clinical trial planning, set-up, launch,...

  • VP Clinical Development

    Gefunden in: beBee S DE - vor 3 Wochen

    Munich, Deutschland Proclinical Vollzeit

    Proclinical are recruiting for a VP Clinical Development (m/w/d) to join a biotech organisation. This role is on a permanent basis and is located in Munich.Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance. Responsibilities:For this role, you will guide clinical trial planning, set-up, launch,...

  • Senior Clinical Research Associate

    vor 1 Tag

    Munich, Deutschland AstraZeneca Vollzeit

    **This is what you will do**: The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local country team(s). The Sr. CRA works in close collaboration with other CRAs and the Country Operations Management (COM) Team to ensure that study commitments are...

  • Director Clinical Development

    Gefunden in: Talent DE 2A C2 - vor 1 Woche

    Munich, Deutschland BioTalent Vollzeit

    Our client is a leading pharmaceutical company dedicated to advancing healthcare through innovative research and development. They are committed to developing breakthrough therapies to address unmet medical needs, particularly in the field of oncology.Position Overview: We are seeking a highly skilled and experienced Medical Director of Clinical Development...

  • Regulatory Procedural Management and Clinical Trial Lead

    Gefunden in: Talent DE C2 - vor 2 Wochen

    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...

  • Senior Program Manager, Network Excellence

    Gefunden in: Talent DE C2 - vor 1 Woche

    Munich, Deutschland Amazon Deutschland Services GmbH Vollzeit

    The EU ATS Network Operations (NetOps) team is looking for Senior Program Manager, Network Excellence. In this role, you will be part of the central Network Operations team in ATS with close interaction to our ATS Supply Chain teams, operational Sort Center teams and global tech stakeholders. As Senior Program Manager, Network Excellence, you will be working...

  • Senior Director, Global Clinical Operations Europe

    Gefunden in: Talent DE C2 - vor 1 Woche

    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...

  • Senior Technical Program Manager

    Gefunden in: Talent DE C2 - vor 1 Woche

    Munich, Deutschland Celonis Vollzeit

    We're Celonis, the global leader in Process Mining technology and one of the world's fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of business processes - and for that, we need you to join us. The Team: You’ll have the opportunity to be a part of our Technical...

  • Clinical Research Associate II

    Gefunden in: beBee S DE - vor 3 Wochen

    Munich, Deutschland Allucent Vollzeit

    EinleitungAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will...

  • Clinical Research Associate Ii

    vor 2 Wochen

    Munich, Deutschland PSI CRO Vollzeit

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,600 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...

  • Program/ Delivery Lead/ Principal Architect

    Gefunden in: Talent DE 2A C2 - vor 2 Wochen

    Munich, Deutschland krg technology inc Vollzeit

    Program/Delivery Lead/Principal ArchitectContractKRG Technologies Inc.Mandatory Technical skills – must be hands onSOA/OSB/JAVA/architect/Delivery lead skillsetsPlease don’t send me non Oracle SOA profiles as this is the primary SkillsetsDemonstrates proven extensive abilities and success managing technical teams across the full software development life...

  • Clinical Research Associate II

    Gefunden in: beBee S DE - vor 4 Wochen

    Munich, Deutschland Allucent Vollzeit

    EinleitungAllucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a...