Mission:

As a RadioPharma Supply Operations Specialist, you manage an efficient and reliable supply chain for Radioisotope and critical components supply to the CDMO’s for drug manufacture. You also plan the dispatch of the produced drug to patients administration sites.

Key Responsibilities:

• Lead sourcing operations and execute procurement contracts and agreements for Radioisotopes for the Belgian Office.

• Expedite external and internal documentation related to the Purchase Orders assigned in order to have timely documentation submission and approvals.

• Make order management including follow up of the entire chain of logistics with import and export.

• Ensure the timely receipt of required permissions and other documents for customs operations by keeping close communication with third party partners (transportation and customs clearance companies)

• Manage day-to-day operation with suppliers

Profile:

• Bachelor’s degree or equivalent in Supply Chain or Logistics or Business Administration related fields.

• Minimum 3 years Industry experience in supply chain. An experience in Pharmaceutical or Radiopharmaceutical environment is a plus.

• Working knowledge of import and export requirements in a regulated environment.

• Fluency both in English and French.

• Strong analytical, planning and organizational skills.

• Experience in Multicultural, Global environment is an advantage.

• Solution-oriented and collaborative mindset.

• Flexibility to adapt to change.

Offer:

• A stimulating and challenging position within a fast-growing global startup company, in which you get to bring your knowledge and skills.

• The opportunity to work in a dynamic, professional, and multicultural environment.

• A permanent contract with an attractive salary package in line with the position responsibilities and your experience. 

Summary:

The Pharmacology & Translational Medicine Specialist plays a crucial role in facilitating the translation of scientific discoveries into tangible healthcare solutions. They collaborate with interdisciplinary teams of researchers, clinicians, regulatory experts, and industry partners to bridge the gap between bench research and bedside applications. Here, the primary focus of this role is to a) interact with the preclinical team to develop high quality documents for submission to different authorities, b) interact with the clinical team to implement various aspects such as Pharmacokinetics and biomarker investigations into the clinical protocol and c) interact with the discovery team for selection of upcoming new targets and compounds.

Key Responsibilities:

Research Facilitation:

• Collaborate with basic researchers to identify promising targets to be developed at FL with defined clinical applications.

• Provide expertise in designing translational research studies that align with clinical needs.

• Facilitate the transfer of laboratory findings into preclinical and clinical investigations.

Project Management:

• Develop and manage project plans for the translation of research concepts into clinical applications.

• Oversee cross-functional teams comprising scientists, clinicians, data analysts, and regulatory experts.

• Monitor project timelines, milestones, and deliverables to ensure progress.

Clinical Trial Design and Implementation:

• Design parts of clinical trial protocols together with the clinical team.

• Monitor clinical trial progress in the context of the TR parts, analyze data, and make recommendations for adjustments based on findings.

Data Analysis and Interpretation:

• Analyze complex scientific and clinical data to identify patterns, trends, and potential therapeutic targets.

• Utilize statistical methods to assess the efficacy and safety of interventions.

Collaboration and Communication:

• Act as a liaison between researchers, clinicians, and industry partners to ensure effective communication and knowledge exchange.

• Present research findings and translational progress at different external and internal meetings.

Regulatory Compliance:

• Stay up-to-date with regulatory guidelines and requirements for the development of medical interventions.

• Ensure that translational research and clinical trials adhere to regulatory standards.

Technology Transfer:

• Facilitate the transfer of intellectual property from academic institutions to industry partners for commercialization.

• Negotiate agreements related to licensing, patents, and intellectual property.

Qualifications:

• A doctoral degree (Ph.D., M.D., or equivalent) in a relevant scientific field (e.g., molecular biology, pharmacology, medicine).

• Strong background in clinical pharmacology.

• Experience in the radiopharmaceutical environment preferable.

• Strong understanding of both basic research and clinical medicine.

• Experience in designing and managing translational research projects.

• Familiarity with regulatory processes and requirements for clinical trials.

• Excellent communication and collaboration skills.

• Proficiency in data analysis and interpretation.

• Ability to work effectively in interdisciplinary teams.

Preferably located close to Heidelberg.

Position overview

The CMC Radiopharmaceutical Manager plays a critical role in overseeing the radiolabelling process, analytical and formulation development, and enabling preclinical and clinical development of therapeutic radiopharmaceuticals. This position entails providing technical support, managing technology transfer, and overseeing manufacturing and supply activities with Contract Development and Manufacturing Organizations (CDMOs). The post holder will collaborate with various teams, including CMC, regulatory, quality, and clinical operations, to ensure the successful development and supply of investigational therapeutic radiopharmaceuticals for clinical development.

Roles & Responsibilities：

• Oversee radiolabelling process, analytical, and formulation development.

• Provide technical support, technology transfer, and management of manufacturing and supply activities with CDMOs.

• Enable preclinical and clinical development of therapeutic radiopharmaceuticals.

• Support CMC, regulatory, quality, and clinical operations team.

• Manage outsourced therapeutic radiopharmaceutical CMC project activities at various stages of drug development.

• Manage projects according to milestones within agreed time, resources, and cost.

• Manage third-party CDMOs activities, partner network, and innovation, ensuring accuracy and reliability of generated data.

• Manage manufacture and supply of investigational therapeutic radiopharmaceuticals for clinical development, ensuring appropriate level of quality for patient safety.

• Review reports, batch data, and conduct trending/investigation of Out of Trend (OOT)/Out of Specification (OOS) results.

• Collaborate with and support the Quality Assurance function to ensure compliance with Good Manufacturing Practice (GMP).

• Collaborate with and support the regulatory function by authoring and/or reviewing electronic Common Technical Document (eCTD) modules.

• Monitor and highlight Intellectual Property opportunities.

• Comply with the Quality System.

• Provide input to company financial forecasts and budget setting activities; monitor expenditure and highlight any unplanned over or under spends.

Soft skills:

• Strong communication and interpersonal skills.

• Excellent organizational and time management abilities.

• Ability to work independently and prioritize workload effectively.

• Collaborative mindset with the ability to work effectively with cross-functional teams.

• Detail-oriented with a focus on accuracy and reliability of data.

• Demonstrated ability to address challenges and solve problems quickly.

• Adaptability and flexibility to navigate complex project requirements and changing priorities.

Experience:

• Extensive experience in pharmaceutical development, with a focus on radiopharmaceuticals.

• In-depth knowledge of ICH, FDA, and EMA guidance/regulations relevant to pharmaceutical drug development and manufacture.

• Proven experience in managing third-party vendors, including CDMOs.

• Strong project management skills.

• Experience in manufacturing pharmaceuticals, with expertise in process, analytical, or microbiology.

• Additional experience in the development of radiopharmaceuticals is highly desirable.

• Familiarity with authoring and reviewing eCTD Module 3 documents is a plus.

• Experience in outsourced manufacture, analysis, and/or supply chain management.

• Experience in sterile pharmaceutical manufacture/aseptic operations is a plus.

• Knowledge of radiopharmaceuticals analytical methods, process development, scale-up, or automation is advantageous.

Education:

Bachelor's degree in a relevant scientific field; advanced degree preferred.

Preferred industry background:

Life science or pharmacceutical industry.

Other key points:

Ability to work from Denmark at least twice/month.