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 permanent vacancy in hybrid working model in Garching as soon as possible
Oncology Clinical Development Lead (f/m/d)
Your role
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Member of the clinical development team, with key role of providing clinical oncology strategy to the entire development pipeline and acting as a clinical development lead for assigned compounds during phase 1-3
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Develop and lead the clinical development plans for the assigned compounds, provide oncology expertise and strategic contribution to the entire pipeline, being the core team member for respective program(s), leading the clinical working team and present clinical aspects of the program(s) to the upper management
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Interact closely with other (core team) functions e.g. preclinical development, medical affairs, regulatory affairs, pharmacovigilance, clinical operations, dosimetry in developing compounds through the different clinical development phases and phase transitions
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Lead the design of clinical study protocols, the execution of the clinical trials and the writing of clinical study reports, according to current international regulations and guidelines
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Provide medical leadership to ITM with particular focus as a subject matter expert in oncology
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Support strategic development of the company with the identification and assessment of new molecular entity opportunities, with participation in due diligence activities
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Lead the organization and running of national and/or international expert consultations and multidisciplinary advisory boards
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Contribute to the publications related to clinical data and presentation of results at internal and external meetings
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Ensure integrity of data and interpretation of clinical study results
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Lead the development and medico-scientific interactions with regulatory authorities for assigned development projects (e.g. Investigator Brochures, regulatory dossiers, scientific advice meetings, answering List of Questions)
Your profile
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MD or PhD, preferably with a board accreditation in oncology or track record in oncology
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Solid experience (track record of > 5 years in the industry) in oncology clinical development of new chemical entities (early and late clinical stage development, development of the clinical strategy, setting up a clinical development plan and target product profiles in collaboration with other functions), experience in radiotheranostic development would be a distinct advantage
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Solid background in the development of clinical study protocols and study reports including sound knowledge of clinical development methodology and study designs
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Previous experience in due diligence activities
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Sound knowledge of ICH-GCP and other relevant regulations/guidelines
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Experience in interacting with regulatory authorities
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Expertise in leading complex medical and scientific discussions and synthesize and clear communication of information
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Strong team orientation and proven leadership capabilities, combined with the ability to navigate a mid‑sized, matrixed organization with a strategic mindset
- Excellent written and spoken English skills, German skills are a plus
Our offer
- Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom
- An open working atmosphere in an international corporate culture with short communication channels
- Comprehensive onboarding programme
- Flexible working hours with home office options
- Attractive special payments
- Just a good salary? Not with us! We also offer you
- Employee participation programme
- Job bike or subsidised job ticket
- Above-average contribution to the company pension scheme
- Individually tailored further training programme (including German and English courses)
- Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)
ITM is an employer that ensures equal opportunities. Qualified applicants are encouraged to apply and will be considered during the selection process regardless of gender, age, national or ethnic origin, religion or belief, disability, sexual orientation, gender identity, or any other characteristic protected under the German General Equal Treatment Act (AGG).
If you are a qualified individual with a disability or are otherwise covered under applicable law and are unable to apply through our online application process, you may request a reasonable accommodation. Please contact career@itm-radiopharma.com.
When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.
Contact
ITM Isotope Technologies Munich SE
People & Culture
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland
Note for recruitment agencies
Please note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!
More about ITM
With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!
For more information please visit: www.itm-radiopharma.com
