Sr. Clinical Development Leader Oncology

vor 3 Wochen

Berlin, Deutschland Bayer Vollzeit

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Sr. Clinical Development Leader Oncology M/F/d**

**YOUR TASKS AND RESPONSIBILITIES**

The Sr Clinical Development Leader will be responsible for all strategic (phase II-III/IV) and operational clinical development activities for Oncology development projects (phase II - III/IV) or clinical life-cycle management activities for marketed products and will also provide late-stage clinical development input for early development assets in phase I. The position will focus on Radium-223 and Targeted Radionuclide Therapies.

**Key Tasks**:

- Leads the Global Clinical Development (GCD) Team, a cross functional, multinational team of internal experts, through clinical phase II - III trials, global product registration, and trials supporting product life cycle optimization. Sets project-related objectives with GCP team members and provides input to their annual performance evaluation (PMP completed by the functional line manager). Requests GCD team members and clarifies resource availability with global functional heads.
- Member of the Global Development Team and representing GCD in related teams, eg Early Development Teams, Global Medical or Commercial Team, PV teams, Due Diligence teams etc.
- In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower).
- Responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved resources. Oversees CRO activities together with clinical operations and proactively initiates corrective action as needed.
- Responsible for the ongoing risk-benefit assessment of a compound until approval in a main country. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate.
- In consultation with the GDL (Global Development Leader) / Head of Clinical Development, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities). Prepares assessments and recommendations at Decision Points and presents them to internal governance / management bodies.
- Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents. Compiles and maintains Investigators’ Brochures (IB).
- Provides medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for early development projects) and defines together with other stakeholders the publication strategy. Approves publications and ensures consistency of publications with clinical data and publication strategy.
- Contributes to Opinion Leader development and publications strategy with implementation detail.
- Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development.
- Provides medical assessment of in
- and out-licensing opportunities of development projects
- Reviews and approves study concepts to ensure compliance with global strategy.

**WHO YOU ARE**
- Highly successful M.D. with extensive professional and academic experience. Board certification in Medical Oncology is preferred
- Proven leadership, motivational and interpersonal skills
- In-depth understanding of the drug development and commercialization process with several years of experience in Oncology Clinical Development.
- Must provide clear vision, direction, and purpose in the different cultures present within the global Medical Organization
- Incumbent must embrace change and be able to work in a changing environment
- Strong communication skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,
- Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively.

LI-GH

LI-GH

**YOUR APPLICATION**

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing population

  • Associate Head Oncology TMCP

    vor 1 Monat

    Berlin, Berlin, Deutschland Pharmiweb Vollzeit

    EinleitungTHE POSITIONWould you like to transform patients' lives and contribute to eliminate cancer as a cause of death? Do you have a background within immuno-oncology and translational medicine and have an interest in working with exciting novel oncology assets? If so, then join us We are building a strong oncology portfolio of novel tumor targeted and...

  • Director Translational Modeling

    vor 4 Wochen

    Berlin, Deutschland Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Vice President Clinical Development

    vor 4 Wochen

    Berlin, Deutschland Thornshaw Scientific Recruitment Vollzeit

    Posted date 03 March 2023 - LocationBerlin - Job type Permanent - SalaryNegotiable - Discipline Life Sciences - ReferenceJO-2303-511715 Vice President Clinical Development - Neuroscience Location: Europe remote based **Salary**: Competitive JO-2303-511715 Are you an expert within Neuroscience? Are you seeking a step up into a VP level role? Do you...

  • Senior Clinical Research Associate

    vor 4 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    Requisition Number7836Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Senior Clinical Research Associate

    vor 4 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Remote-Arbeit Freiberufler Vollzeit

    Requisition Number7835Employment Type:Contractor Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Senior Clinical Research Associate

    vor 9 Stunden

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    **Requisition Number**7835** **Employment Type**:Contractor** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s...

  • Senior Clinical Research Associate

    vor 4 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    **Requisition Number**7836** **Employment Type**:Regular** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s...

  • Clinical Evaluation Expert

    vor 4 Wochen

    Berlin, Deutschland Klenico Health Vollzeit

    Klenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness. In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders. We are...

  • Clinical Evaluation Expert

    vor 4 Wochen

    Berlin, Deutschland Klenico Health Vollzeit

    Klenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness. In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders. We are...

  • Clinical Evaluation Expert

    vor 4 Wochen

    Berlin, Deutschland Klenico Health Vollzeit

    Klenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness.In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders.We are currently...

  • Clinical Evaluation Expert

    vor 4 Wochen

    Berlin, Deutschland Klenico Health Vollzeit

    Klenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness. In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders. We are...

  • Clinical Trial Ambassador

    vor 1 Monat

    Berlin, Deutschland Syneos Health Commercial Solutions Vollzeit

    **Overview** The Clinical Trial Ambassador will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice as it relates to areas of interest. This position interacts with various internal and external stakeholders, with a focus on...

  • Head of Clinical Affairs

    vor 4 Wochen

    Berlin, Deutschland ZEISS Group Vollzeit

    Your role- develop and execute clinical development plans, in particular for clinical studies that are in line with our company's vision for the medical devices in ophthalmology (Class IIb/III implants)- further development of the department, successfully strengthen expertise e.g. by implementing innovative concepts for the design and execution of (global)...

  • Sr. Program Manager

    vor 4 Wochen

    Berlin, Berlin, Deutschland ZEISS Gruppe Vollzeit

    Sr. Program Manager (PMO) Business Sector SAS (f/m/x) page is loadedlocationsBerlinMünchenJenaOberkochenFull timeposted onPosted 8 Days Agojob requisition idJR_1032098Your RoleSupport the Business Sector Head and the Sr. Leadership Team, acting as a multiplier for the activities of the business sector.In addition to completing a wide variety of tasks, the...

  • Clinical Research Associate

    vor 1 Monat

    Berlin, Deutschland ProPharma Group Vollzeit

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...

  • Sr. Software Development Engineer, Amazon Robotics

    Vor 4 Tagen

    Berlin, Deutschland Amazon Development Center Germany GmbH Vollzeit

    Amazon Robotics is seeking broad, curious engineers to join our team. We holistically design, build, and deliver end-to-end robotic systems. Our team is also responsible for core infrastructure and tools that serve as the backbone of our robotic applications, enabling roboticists, machine learning scientists, software engineers, and hardware engineers to...

  • Sr. Data

    vor 4 Wochen

    Berlin, Deutschland Mozilla Vollzeit

    The Mozilla Foundation is a nonprofit public benefit organization. Our mission is to ensure that the Internet is a global public resource, open and accessible to all. Join us and become part of our mission to promote openness, innovation, and opportunity online! Twenty years ago, this meant building a browser and protecting the open web. Today, it also...

  • Senior Director of Statistical Methodology

    vor 3 Wochen

    Berlin, Deutschland AL Solutions Vollzeit

    Aramis is partnered with a cutting-edge biopharmaceutical company committed to innovation, research, and development has positioned them as a leader in the industry. With a focus on Infectious Disease and Oncology studies, they are seeking a dynamic and experienced Statistical Methodology Leader with a Biostatistics background to join their passionate...

  • Site Activation Specialist

    vor 4 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    **Requisition Number** **6467** **Employment Type***: **Contractor** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Human Resources Lead

    vor 1 Monat

    Berlin, Deutschland Fosanis GmbH Vollzeit

    **In a nutshell**: As the HR Lead, you will play a pivotal role in shaping and implementing our human resources strategy. You will lead a team of HR professionals and collaborate closely with department heads to ensure the effective development and execution of HR initiatives that align with the company's goals. The HR Lead will be responsible for overseeing...