Company

Itm Isotope Technologies Munich SeSee more

addressAddressGarching bei München, UK
type Form of workPermanent
salary SalaryCompetitive
CategoryHealthcare

Job description

About ITM ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM). We would like to fill the following vacancy in a hybrid or remote working model as soon as possible: Clinical Development Manager - Nuclear Medicine (f/m/d) Nuclear Medicine Expertise: develop expertise in targeted radiotherapy, including diagnostic and therapeutic agents (theranostics), within the medical team Clinical Development Support: key role in designing and executing early and late clinical development projects, collaborating closely with preclinical development Protocol Development and Safety Oversight: Support the development of clinical study protocols, ensuring compliance with international regulations, with a focus on imaging and dosimetry and collaborate with the Drug Safety Team to monitor compound safety in clinical development Technology Integration: work with the Nuclear Medicine Lead and dosimetry team to develop and utilize in-house Hermes image viewer and dosimetry platform for clinical projects Scientific Support and External Engagement: Provide scientific support across the development portfolio, contributing to due diligence, early development, and commercialization and represent Nuclear Medicine externally with experts, regulatory authorities, and advisory boards Clinical Development Activities: Support Clinical Medical Lead(s) in study strategy, design, data analysis, interpretation, and report generation Regulatory Contribution and Study Oversight: Contribute to regulatory submissions, including IND / CTA, NDA / BLA / MAA, DSUR, and INDSRs and manages ongoing studies, ensuring effective communication with sites, stakeholders, and regulatory bodies Physician (f/m/d) specialized in Nuclear Medicine with theranostic experience Ability to manipulate and interpret nuclear medicine images. Background with segmentation tools and dosimetry expertise is encouraged First professional work experience in a drug / biologic developing company, ideally in oncology indication or as clinical investigator in industry sponsored trials Ability to work in a hierarchically flat, matrix environment Strong working knowledge of the clinical drug development process, clinical trial design, data management (including CDISC standards) and biostatistics Ability to understand, integrate, analyse and interpret clinical data Good management, interpersonal, communication, negotiation and problem-solving skills Fluency in English A modern workplace and exciting opportunities in an evolving and fast-growing company Challenging and varied projects in interdisciplinary, multicultural and highly professional teams A collegial corporate culture and short communication channels Flexible working hours with an attractive salary package and diverse corporate benefits

Refer code: 2777462. Itm Isotope Technologies Munich Se - The previous day - 2024-02-13 12:47

Itm Isotope Technologies Munich Se

Garching bei München, UK

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