Director Clinical Affairs (m/f/d)

Part-time 50%

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

  • Leads clinical program(s) in accordance with the clinical development
    strategy for the clinical program(s). Applies industry standard risk based
    oversight of the clinical studies that are part of the clinical development
    Collaborates closely with the CRO including but not limited to
    guidance regarding medical and clinical development activities, i.e.
    education of the CRO’s medical personnel, investigators and study site
    personnel oversees risk based medical monitoring, protocol deviations ,
    adherence to medical monitoring plans, quality elements etc. Documents
    the oversight to pass inspections. His/her responsibilities include
    providing clinical input for all activities related to an early clinical
    development to mature product lifecycle management
  •  Leads/participates in cross-functional teams providing clinical input on behalf of the clinical team, involved in the interpretation of the clinical results and their communication to internal and external stakeholders
  •  Accountable for preparation of the clinical part of briefing books and regulatory documents for the interactions with the Health Authorities (HA), preparation of clinical parts of marketing authorization dossiers and responses to subsequent questions. Attendance as needed to HA
  • Provides input to device related clinical questions as ie human factor
    study protocols
  • Accountable for setting the scope for clinical content of Clinical Studies, Protocols, Investigator Brochures, Clinical Study Reports, Clinical Modules for submission, including Integrated Summary of Efficacy, together with the safety colleagues for the Integrated Summary of Safety, pediatric study plans, and other documents as needed
  •  Accountable and responsible for sponsor elements for inspection readiness related to the clinical elements including respective parts of the TMF
  •  Talking as needed clinical leadership role in meetings with the HA presenting the Company position regarding the clinical programs and the strategy for its achievement
  •  Contributes to the data disclosure of clinical trials’ results including but not limited to publications
  •  Assures high quality input to budget for the clinical areas and manages related activities (contracts with consultants, invoices etc)
  • Contributes to due diligence activities as required
  • Ensures adherence to Good Clinical Practices, pharmacovigilance
    standards, standard operating procedures and to all other quality
    standards in conducting research related to his/her work

EDUCATION:

Medical Doctor is preferred, alternatively a PhD in a biological
area, Vet med .


WORK EXPERIENCE:

At least 5 years for a MD, 7 years for a PhD of clinical
development experience in the pharmaceutical industry or CRO preferably in
biotechnology in a global role, leading clinical development activities from
early stage development to submission and approval by the HA.


JOB SPECIFIC COMPETENCIES & SKILLS:

• Ability to lead and manage complex clinical program(s)
• Ability to assess risks and provide innovative solutions related to the
assigned clinical program(s) and to present risk-benefit assessment to
the clinical team and senior management if requested
• Ability to lead cross-functional teams in the matrix model and to motivate
by example the other team members with a ‘can do’ attitude
• Willingness to take accountability, hands on including administrative
and operational tasks with an open mindset
• Ability to work constructively without micromanagement with CROs
with a resource efficient mindset
• Excellent communication skills to represent the organization during
interaction with HA, external stakeholders, including key opinion
leaders
• High commitment for achievement the Business unit goals
• Ability to think strategically and drive clinical programs with the right
decision-making mindset considering short and long-term impact of
his/her decisions
• Work experience in a multinational environment
• knowledge of clinical strategies, clinical trial methodology, including
statistics and relevant regulatory policies preferably in the biosimilar
field of development


LANGUAGES:

Excellent oral and written command of English language

  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Klinische Studien / Statistik
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • International / Eysins
  • Bewerbungsfrist:
  • none - we look forward to your application
Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 43970

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Director Clinical Affairs (m/f/d)

Part-time 50%

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Your assignments

  • Leads clinical program(s) in accordance with the clinical development
    strategy for the clinical program(s). Applies industry standard risk based
    oversight of the clinical studies that are part of the clinical development
    Collaborates closely with the CRO including but not limited to
    guidance regarding medical and clinical development activities, i.e.
    education of the CRO’s medical personnel, investigators and study site
    personnel oversees risk based medical monitoring, protocol deviations ,
    adherence to medical monitoring plans, quality elements etc. Documents
    the oversight to pass inspections. His/her responsibilities include
    providing clinical input for all activities related to an early clinical
    development to mature product lifecycle management
  •  Leads/participates in cross-functional teams providing clinical input on behalf of the clinical team, involved in the interpretation of the clinical results and their communication to internal and external stakeholders
  •  Accountable for preparation of the clinical part of briefing books and regulatory documents for the interactions with the Health Authorities (HA), preparation of clinical parts of marketing authorization dossiers and responses to subsequent questions. Attendance as needed to HA
  • Provides input to device related clinical questions as ie human factor
    study protocols
  • Accountable for setting the scope for clinical content of Clinical Studies, Protocols, Investigator Brochures, Clinical Study Reports, Clinical Modules for submission, including Integrated Summary of Efficacy, together with the safety colleagues for the Integrated Summary of Safety, pediatric study plans, and other documents as needed
  •  Accountable and responsible for sponsor elements for inspection readiness related to the clinical elements including respective parts of the TMF
  •  Talking as needed clinical leadership role in meetings with the HA presenting the Company position regarding the clinical programs and the strategy for its achievement
  •  Contributes to the data disclosure of clinical trials’ results including but not limited to publications
  •  Assures high quality input to budget for the clinical areas and manages related activities (contracts with consultants, invoices etc)
  • Contributes to due diligence activities as required
  • Ensures adherence to Good Clinical Practices, pharmacovigilance
    standards, standard operating procedures and to all other quality
    standards in conducting research related to his/her work

Your profile

EDUCATION:

Medical Doctor is preferred, alternatively a PhD in a biological
area, Vet med .


WORK EXPERIENCE:

At least 5 years for a MD, 7 years for a PhD of clinical
development experience in the pharmaceutical industry or CRO preferably in
biotechnology in a global role, leading clinical development activities from
early stage development to submission and approval by the HA.


JOB SPECIFIC COMPETENCIES & SKILLS:

• Ability to lead and manage complex clinical program(s)
• Ability to assess risks and provide innovative solutions related to the
assigned clinical program(s) and to present risk-benefit assessment to
the clinical team and senior management if requested
• Ability to lead cross-functional teams in the matrix model and to motivate
by example the other team members with a ‘can do’ attitude
• Willingness to take accountability, hands on including administrative
and operational tasks with an open mindset
• Ability to work constructively without micromanagement with CROs
with a resource efficient mindset
• Excellent communication skills to represent the organization during
interaction with HA, external stakeholders, including key opinion
leaders
• High commitment for achievement the Business unit goals
• Ability to think strategically and drive clinical programs with the right
decision-making mindset considering short and long-term impact of
his/her decisions
• Work experience in a multinational environment
• knowledge of clinical strategies, clinical trial methodology, including
statistics and relevant regulatory policies preferably in the biosimilar
field of development


LANGUAGES:

Excellent oral and written command of English language

Ihr Kontakt

Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 43970

Karrierelevel
Berufserfahrene
Einsatzbereich
Klinische Studien / Statistik
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
International / Eysins
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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