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Senior Director Medical Affairs and Clinical Development

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We are currently looking for a Senior Director Medical Affairs and Clinical Development
Line reporting:  Chief Medical Officer
 
Responsibilities with full decision making empowerment: *


Medical Affairs, Neurology/Neuroimaging
  • NeuraCeq (18F-florbetaben, FBB) scan reading training programs and implementation for both trainers and readers on a global level
  • Member of PI’s publication and data generation teams
  • Perform image data analysis/interpretation
  • Give presentations and posters at International meetings
  • Advisor to commercial on issues in neuroscience
  • Internal education program development and implementation for PI’s marketing, field force (including “brand differentiation” concepts)
  • Educate market development managers will then interact with payers, societies, KOLs, and decision makers
  • Strategy development to foster the engagement of referrers in the use of the products and relationships with Nuc Med Physicians (e.g. referrer workshops) with particular focus on DACH region (Germany, Austria, Switzerland)
  • Work closely with market managers to interact with payers, societies, KOLs, and decision makers upon request with particular focus on, but not limited to, DACH Region
  • Scientific content for marketing material preparation
  • Life cycle management FBB and future neuroimaging compounds
  • Responsible for post approval safety studies (PASS) and other required Phase 4studies.
  • Pharmacovigilance liason with Global Qualified Person Pharmacovigilance (QPPV)

Clinical Development
  • Responsible to provide medical knowledge and expertise for all aspects of the FBB project.
  • Will lead clinical studies performed globally and will represent PI in meetings with authorities and ethics committees and is an acknowledged counterpart for external key opinion leaders.
    • Work with a matrixed team of Project management, Clinical Operations, Regulatory and external CROs to accomplish above
  • Responsible for study reports and for clinical input into the submission dossiers (IND, NDA, sNDA)
  • Will liaise with regulatory and Medical affairs.
  • Set enrollment / diagnostic criteria and testing for the clinical condition of interest based on consultation with other experts and an understanding of the relevant literature
  • Training / standardization of clinical sites on the clinical aspects of relevant protocols
  • Co-lead clinical / strategic advisory board meetings
  • Work to formulate regulatory strategy and write regulatory position papers
  • Formal responsibility for patient safety (safety officer in conjunction with established QPPV), review and handle clinical trial related Adverse Events/Serious Adverse Events
  • Writing clinical neuroscience grants and research publications as appropriate
 
Requirements
  • MD with at least 5 years Pharma experience in Neurology or Neuro-Imaging
  • Board certified or equivalent in Neurology, Nuclear Medicine, or Radiology
  • Sufficient knowledge in Neuroimaging and Neuroanatomy to teach Reader Training to Nuclear Medicine/Radiologists
  • Deep expertise in the fundamentals of nuclear medicine and radiopharmaceutical development.
  • Scientifically oriented.Able to design clinical studies and analyze data in a critical quantitative manner
  • Proven Publication record.
  • Outgoing and enthusiastic.Able to engage converse and motivate KoLs.
  • Excellent communication skills and fluency in German and English

Kontaktdaten


Art des Bewerbungszugangs
Email
Kontakt für Bewerbungen
Emmanuelle Delabre

Piramal Imaging GmbH
Tegeler Straße 6-7
13353 Berlin
Germany


 

Details der Stellenanzeige


Arbeitszeit
Vollzeit
Vertragslaufzeit
Festanstellung
Stellentyp
Bereichs- & Abteilungsleitung
Berufserfahrung
Berufserfahrung vorausgesetzt
Region
Deutschland (Berlin)
Arbeitsort
13353 Berlin
Fachgebiet
Healthcare & Gesundheitswesen, Biologie & Life Sciences, Chemie, Pharma, Humanmedizin
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