Clinical Lead

vor 2 Wochen

Lausanne, Waadt, Schweiz AC Immune SA Vollzeit

Clinical Lead

Description
Function Clinical Lead
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne

Percentage 100 %
Reporting Line Head of Clinical Development
Company Profile
•AC Immune is a clinical stage Swiss biotech company focused on the
development of innovative therapeutics and diagnostics for Alzheimer's
and other neurodegenerative diseases

  • 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ
  • AC Immune SA (ACIU) is a progressive, equal opportunity employer

Job description Clinical Lead takes responsibility to lead the clinical development activities of
one or more clinical programs. Current clinical programs focus on
neurodegenerative diseases (eg., Alzheimer's disease, Parkinson disease).
She/He develops the clinical development plans and clinical project strategy,
including a translational biomarker strategy. The Clinical Lead participates
notably to the clinical study team and core team, representing the clinical
development. As a key contributor she/he takes responsibility for developing
study plans and protocols according to the agreed company's strategy. The
Clinical Lead is responsible to implement the clinical and biomarker
development strategy notably based on data from the competitive landscape
and from the most recent state of the art, medical and scientific knowledge.
She/He takes part in and supervises all the key steps related to the
preparation, the conduct and the completion of the clinical studies, including
the medical and safety monitoring, associated to the related clinical program
sponsored by ACIU. She/He also provides appropriate support to the clinical
operations team and other key stakeholders.
Key Responsibilities
•Leads the direction, planning, execution and interpretation of assigned
clinical trials, with a focus in neurodegenerative diseases.

  • Takes part in the elaboration of clinical strategy and clinical
    communication, with a leading role in neurodegenerative diseases.
  • Leads the development of the assigned clinical development program
    and 5-year clinical plans in alignment with ACIU strategy.
  • Ensures/supervises the interpretation of the data from internal clinical
    trials and from competitors.
  • Establishes/reviews clinical study designs and implement clinical
    protocols, data collection systems and final clinical study reports.
  • Supervises, in respect with GCP, adherence to protocols and to clinical
    reports including medical/safety aspects.
  • Supervises/takes part in the medical and safety monitoring and reports
    promptly serious adverse events or any safety concerns considered of
    medical significance according to internal SOPs.
  • Takes part in the DSMB blinded meetings.
  • Prepare/takes part in investigator's meetings.
  • Generates presentations, publications and interfaces with KOLs,
    external experts, advisory boards, and health authorities.
  • Provides medical support to due diligences associated with in-licensing,
    acquisitions, and co-development agreements, under supervision of the
    head of clinical development and the CMO.

Clinical Lead

  • Ensures/handles clinical interfaces with external partners.
  • Ensures competitive intelligence in the related field in order to implement
    a state-of-the-art approach for the related clinical development program
    and clinical studies.
  • Supervises/provides support on the preparation, the review and the
    finalization of key clinical documents including, but not limited to, clinical
    development plan, clinical protocols and related amendments, clinical
    study reports, investigator's brochures, DSURs, and other key study
    documents as appropriate.
  • Provides support to the clinical operation team and other stakeholders
    as needed.

Qualifications & SkillsRequired:

  • MD or MD/PhD
  • Expertise or training in Neurosciences.
  • Experience in clinical development programs in Central Nervous System
    Diseases, Neurodegenerative Diseases.
  • 5+ years of experience in clinical development (academic and/or
    pharmaceutical or biotech companies) including preparation of key
    clinical study documents (e.g., but not limited to clinical study protocols,
    investigator's brochures).
  • Knowledge of clinical development process and related guidelines,
    GCP, ICH.
  • Experienced in the establishment and the maintenance of
    communication with KOLs, external experts and regulatory authorities.
  • Advanced communication skills, verbal and written.
  • Team player.
  • Demonstrated ability to synthesize, analyze and communicate key
    information.
  • Strong interpersonal skills for building networks with key experts and
    ensuring the interface with internal departments and project team
    members.
  • Ability to adapt priorities to meet company needs while maintaining
    effectiveness.
  • Leadership and project management skills.
  • Good spoken and written English.

Would be a big plus:

  • Neurologist
  • Experience in pharmacovigilance.
  • Experience in translational sciences.

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