(Sr.) Clinical Trial Leader

vor 4 Wochen

Allschwil, Schweiz Alentis Therapeutics AG Vollzeit

**Job Profile**:
Alentis' lead therapeutic program, ALE.F02, has finished recruitment into a Ph1a study in healthy volunteers and is currently being developed for the treatment of advanced fibrotic diseases. ALE.C04 will enter clinical studies in oncology in 2023.

**Key words**:
Clinical trial documents authoring; Lead clinical trial team; CROs management; Operational excellence; Clinical trial data review

**Responsibilities**:

- Act as Alentis ambassador towards investigators, external vendors and partners
- Develop effective working relationship with key investigators in assigned therapeutic area to optimize trial execution and scientific interaction
- Plan and support the organization of Investigator meetings and site staff training events
- Optimize trial-related working processes to facilitate collaborations with partners
- Contribute to trial/disease-related advisory boards
- Guide external vendors (including but not limited to CRO) to demonstrate high-quality interactions with investigators/sites.
- Manage and execute the clinical trial preparation and conduct:

- Lead the development of study documents such as the synopsis, protocol, ICF, study-specific guidelines and plans in accordance with internal SOPs and GCP requirements
- Contribute to the development of regulatory documents (e.g. Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents), coordination of responses to Health Authority and EC/IRB questions
- Lead and matrix manage the trial team (either partially or fully outsourced to CRO) to ensure all trial deliverables are met according to timelines, budget, and resource requirements, the activities include but not limited to:

- Oversee forecasting of IMP and study material supplies
- Review and contribute to the selection of countries and investigative sites
- Contribute to vendor evaluation and selection, assist in contract preparation
- Responsible for vendor oversight and the initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with the scope of work
- Ensure set up and maintenance of study reporting tools and tracking systems to oversee and report the study progress to the Management Team
- Contribute to the develop of recruitment and risk-mitigation plans. Monitor and implement contingencies as required. Escalate unresolved issues and mitigation options to the Management Team
- Oversee monitoring activities. Review monitoring reports and protocol deviations
- Ensure timely data entry and close oversight of data cleaning activities
- Proactively address issues, identify, and implement actions to keep study on track in a timely fashion
- Support/coordinate inspection readiness, audits and CAPA resolution activities to enable satisfactory outcome
- Ensure that proper study documentation is maintained and archived in the sponsor and CRO (e)TMF
- In collaboration with Alentis’ medical and clinical pharmacology responsible contribute to the clinical trial data ongoing clinical review, final analysis and interpretation including the development of dose finding reports, clinical trial reports, publications and internal/external presentations
- Contribute to the development and improvement of clinical SOPs
- Implement best practices and standards for trial management with the goal of operational excellence
- Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP, applicable regulations and SOPs.

**Qualifications, Experience and Competencies**:

- Advanced degree in life science or healthcare is required. PharmD or PhD is strongly preferred.
- 7 years of experience in a biopharmaceutical industry or biotech setup
- 5 years of experience in clinical research or drug development. Early clinical trials experience is an asset.
- 3 years of managerial experience in planning, implementing, reporting and publishing clinical studies.
- Hands-on experience in
- development of study documents (e.g. synopsis, protocol, informed consent etc.)
- contribute and/or development of regulatory documents (e.g. Investigators’ Brochure, IND/NDA documents etc.)
- patient data review, cleaning, analysis and interpretation
- data visualization tool (e.g. Spotfire)
- clinical research expertise in oncology or fibrosis
- selection and managing external service providers and vendors
- clinical trial budget management
- Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently
- Strong communication and presentation skills
- Fluent in spoken and written English (additional languages advantageous)
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff)

**What we offer**:

- The opportunity to contribute to the development of First-In-Class molecules in an innovative leading Biotech environment in the fi

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