Senior Clinical Safety Scientist

vor 5 Monaten

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 protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our European Headqurters in Munich we are looking for a

**Senior Clinical Safety Scientist (M/F/x)**:
**The position**:

- The Senior Manager, Clinical Safety Scientist Oncology supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle and independently leads activities without supervision for assigned clinical studies.
- The job holder acts as Subject matter expert (SME) in one or more focus areas and may start to develop people management skills by mentoring and coaching junior Clinical Safety Scientists or post-doctoral fellows.
- The job holder acts as audit/inspection SME for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation, and may serve as primary or back-up SME.

**Roles & responsibilities.***:

- Risk Management (Signal identification, evaluation, mitigation):

- Supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety Physician(s), and cross-functional team(s) in support of benefit risk profile throughout product lifecycle
- Independently evaluates safety data of any source to identify potential safety signals, tracks safety signals in the global electronic signal tracking tool and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teams
- Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetings
- Collaborates with Clinical Safety Scientist Product Lead and PSL to develop minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs)
- Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product
- Safety Communication:

- Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents
- Collaborates with Clinical Safety Scientist Lead and PSL to author safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)
- Contributes to regulatory authority requests or communication for assigned clinical studies
- CTD submissions/Others:

- May support Common Technical Document (CTD) submissions by collaborating with Clinical Safety Scientist Lead, Clinical Safety Physician(s), PSL, and cross-functional team to develop safety strategy, key safety messages, and review and author safety sections of CTD
- Develop expertise in one or more focus areas
- Supports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as needed
- Acts as audit/inspection Subject Matter Expert (SME) for safety surveillance and risk management for assigned clinical studies, through inspection readiness preparation, serving as primary or back-up SME
- Project Management:

- Coordinates SMT/Product-level safety meetings, maintains roster, calendar, and minutes, and communicate materials, in support of the Clinical Safety Scientist Product Lead and PSL
- May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed

**Professional experience & education**:

- Education and experience
- Bachelor’s degree at minimum required; PharmD or PhD preferred
- 2 years of experience with an advanced degree; 5 years of experience with a bachelor’s degree
- Possesses scientific or therapeutic area, and drug development knowledge
- Experie

  • Senior Principal Clinical Data Scientist

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Biostatistics and Data Sciences (BDS) is a global organization with more than 400 employees within the Human Pharma Business Unit. Working in close collaboration with other functions at Boehringer Ingelheim (BI) and external vendors we combine methodological and technical data science skills with business and scientific expertise to drive...

  • Director Clinical Safety

    vor 6 Monaten

    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 Principal Scientist

    vor 5 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **THE POSITION**: You will also have the exciting prospect of acting as a Data Science Lead (DSL) in clinical development project teams to fulfill our vision of turning data into knowledge. As DSL, you’ll have the chance to shape and contribute to projects already prior to first-in-man clinical trials. This position can be filled in Ingelheim or...

  • Clinical Services Engagement Associate, Germany

    vor 4 Wochen

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    Job Summary:Clinical Services Engagement Associate works in a pivotal role of managing communication and activities among clinical research sites, and internal stakeholders to prepare for and complete clinical assessments in accordance to the project specific scope of work.Key Responsibilities:Partner with external customers such as clinical research sites,...

  • Senior Principal Scientist

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **THE POSITION**: You will also have the exciting prospect of acting as a Data Science Lead (DSL) in clinical development project teams to fulfill our vision of turning data into knowledge. As DSL, you’ll have the chance to shape and contribute to projects already prior to first-in-man clinical trials. **Tasks & responsibilities**: - As a Senior...

  • Senior Scientist

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **THE POSITION**: If you would like to learn more on the vision and mission of our TMCP Data Science department, please see below in TMCP Data Science Section. This position is part time eligible. **Tasks & responsibilities**: As Senior Scientist in Pharmacometrics, you will develop the pharmacometrics strategy for clinical development projects and...

  • Clinical Data Scientist

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Biostatistics and Data Sciences (BDS) is a global organization with more than 400 employees within the Human Pharma Business Unit. Working in close collaboration with other functions at Boehringer Ingelheim (BI) and external vendors we combine methodological and technical data science skills with business and scientific expertise to drive...

  • Senior Scientist

    vor 7 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **THE POSITION**: If you would like to learn more on the vision and mission of our TMCP Data Science department, please see below in TMCP Data Science Section. This position can be filled in Ingelheim or Biberach. **Tasks & responsibilities**: As Senior Scientist in Pharmacometrics, you will develop the pharmacometrics strategy for clinical development...

  • Clinical Services Engagement Associate, Germany

    vor 4 Wochen

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    Job Summary:Clinician Services Engagement Associate plays a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with project-specific scope of work.Key Responsibilities:Partner with external customers, such as clinical research sites, and...

  • (Senior) Clinical Program Lead

    vor 6 Monaten

    Munich, Deutschland BI International GmbH Vollzeit

    **The Position**: As (Senior) Clinical Program Leader you assume global responsibility and medical leadership for clinical development and evidence generation for assets in the Therapeutic Area Inflammation from start of development through to registration. This may include definition of Target Product Profiles, design and execution of congruent,...

  • Clinical Safety Coordinator

    vor 6 Monaten

    Munich, Deutschland Medpace, Inc. Vollzeit

    Job Summary: Our German activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team in Munich! This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an...

  • Clinical Services Engagement Associate, Germany

    vor 1 Monat

    Munich, Bayern, Deutschland WCG Clinical Vollzeit

    Job Summary:Clinician Services Engagement Associate plays a pivotal role in managing communication and activities among clinical research sites and internal stakeholders to prepare for and complete clinical assessments in accordance with project-specific scope of work.Key Responsibilities:Partner with external customers, such as clinical research sites, and...

  • (Senior) Principal Clinical Pharmacokineticist

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **THE POSITION**: As Clinical Pharmacology Lead you act in global development teams with a responsibility for the Clinical Pharmacology development package. You work in a department (Translational Medicine & Clinical Pharmacology) bridging the path from early research to submission interacting with multiple functional areas within BI. You have the choice...

  • (Senior) Principal Scientist Retinal Health

    vor 5 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: We are offering an exciting opportunity as (Senior) Principal Scientist to join the global department Translational Medicine & Clinical Pharmacology (TMCP) at our sites in Biberach or Ingelheim, Germany. This position can be filled in Ingelheim or Biberach **Tasks & responsibilities**: - In your new role you will build an understanding...

  • Senior Peptide Expert Drug Safety

    vor 5 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Peptide drugs are one of the most exciting areas in the pharmaceutical industry. You have experience in the non-clinical safety evaluation of peptide therapeutics and would like to contribute on an efficient development for optimal patient benefit? We offer the chance of a scientific leadership position within the department of...

  • Principal Data Scientist

    vor 6 Monaten

    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **THE POSITION**: You will also have the exciting prospect of acting as a Data Science Lead (DSL) in clinical development project teams to fulfill our vision of turning data into knowledge. As DSL you will have the chance to shape the data science strategy of drug development projects already prior to first-in-man clinical trials ranging up to regulatory...

  • Senior Peptide Expert Drug Safety

    vor 5 Monaten

    Munich, Deutschland Boehringer Ingelheim Vollzeit

    **The Position** Peptide drugs are one of the most exciting areas in the pharmaceutical industry. You have experience in the non-clinical safety evaluation of peptide therapeutics and would like to contribute on an efficient development for optimal patient benefit? We offer the chance of a scientific leadership position within the department of non-clinical...

  • Senior Clinical Program Lead

    vor 5 Monaten

    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...

  • Safety Physician

    vor 5 Monaten

    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 Project Manager

    vor 4 Wochen

    Munich, Bayern, Deutschland Innovaderm Research Vollzeit

    Job Title: Senior Clinical Project ManagerAbout the Role:We are seeking a highly experienced Senior Clinical Project Manager to join our team at Innovaderm Research. As a Senior Clinical Project Manager, you will be responsible for managing clinical trials from start to finish, ensuring that all activities and deliverables are completed on time, on budget,...