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Clinical Lead
vor 2 Wochen
Clinical Lead
Description
Function Clinical Lead
Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne
hr@acimmune.com
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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