Careers

Clinical Affairs Manager

Location: Villeneuve d’Ascq (59) – France

Requested experience: at least 3-5 years managing international clinical trials

Gross salary: 56 – 70 k€ depending on professional experience

Company

Hemerion Therapeutics is a health tech company at a clinical level. Hemerion results of over 10 years of leading academic and clinical researches on innovative approaches to treat Glioblastoma. These new technologies have been evaluated to treat brain cancer through a first-in-human clinical trial. Hemerion owns a unique and disruptive technology, already evaluated in frontline approach to treat patients harboring brain cancer.

Today, to support its clinical development, Hemerion seeks for his/her clinical affairs manager

Description

We are seeking our clinical affairs manager to follow, support and develop our clinical strategy according to good clinical practice (GCP), for the US an EU territory.

Position and responsibilities

Under the supervision of the CEO and in liaison with the Clinical affairs associate, you will be in charge of structuring our clinical department and the strategy of our upcoming clinical trials according to the regulations in force. You will manage our future pivotal study for our first brain cancer therapy and develop clinical research in new therapeutic areas. You will also be responsible for supporting the implementation of ongoing and future studies and ensuring that each study complies with protocol, good clinical practices, regulatory requirements and Hemerion’s standard operating procedures.

Your missions are the following:

  • To coordinate and ensure the on-time and on-budget conduct and implementation of clinical trials
  • To provide clinical support and oversight of all projects at various stages of development, including collaboration with key functions such as the clinical affairs associate, regulatory and quality affairs associate, research and development engineer 
  • To coordinate the operational activities for projects at different stages of development: design of clinical development plans, clinical literature surveys and research, project level risk analysis, writing of briefing books 
  • To initiate and manage our EU/US pivotal trial including but not limited to:
    • Drafting and validation of the study plan, essential documents for regulatory submission and management of clinical trial activities
    • Identification and qualification of possible sites
    • Selection and qualification of clinical service providers CRO/ core labs/ clinical service providers
    • Contribution to the development of clinical SOPs
  • To manage and follow budget and contract in collaboration with CEO and CFO
  • To manage Hemerion’s accounts in regulatory databases (Eudravigilance, CTIS, EUDAMED, Clinicaltrial.gov…) 
  • To contribute to our quality management system

Skills – Education requirements

  • Master’s degree/doctoral degree in sciences or health-related field
  • Comprehensive knowledge of ISO 14155, ICH, GCP, MDR, applicable regulations (EMA- FDA) governing the conduct of clinical trials
  • Demonstrate conceptual skills and knowledge to produce high quality written documents and presentations that effectively communicate in a clear, organized, and concise manner to clinical and regulatory authorities, ethics committees and investigators
  • Excellent oral and written communication skills
  • Organized individual who is self-motivated, detail oriented and able to work with little supervision
  • Fluent English language skills orally and in writing
  • Ability to work well independently as part of a small team with different functions and backgrounds
  • Ability to adapt to changing situations

Profile

  • 3-5 years of experience in Medical Affairs and Clinical Operations in medical devices and/or drug, including monitoring activities
  • Experience in clinical strategy development to achieve market approval and reimbursement for medical devices in EU and US
  • Clinical budget management experience/financial acumen

You like collaborative work, sharing experiences and want to actively participate in the development of our startup, apply now!

Jobs benefits

  • Dynamic environment with opportunities for advancement within the company
  • International and growing company
  • Autonomy in building the job’s functions
  • Eligible to incentives such as BSPCE warrants

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