Head Global Clinical Operations Oncology, Senior Director (100%)
Job Profile

Alentis Therapeutics is developing breakthrough treatments for fibrotic disease and associated cancers. We are putting the brakes on fibrosis and aim to change the course of a disease associated with 45% of deaths in the developed world.

Our unique approach is to develop highly selective monoclonal antibodies against Claudin-1, a novel previously unexploited target. Claudin-1 plays a key role in the development of liver fibrosis and fibrosis-driven cancers. Unlike current therapies, which mostly act on fibrosis in an indirect way, Alentis’ pioneering strategy has the potential to directly modify and reverse fibrosis. Alentis will initiate global clinical trials with several programs in various regions (Europe, USA & Asia) with ALE.F02 in 4Q 2021 and plans to start the Ph2 program in late 2022.

Alentis was founded in 2019 and is headquartered in Basel, Switzerland with an affiliated R&D operation in Strasbourg, France.

We are currently looking to hire a

Head Global Clinical Operations Oncology, Senior Director (100%)

To join our highly motivated teams based in Allschwil.

The ideal candidate will report to the Lead of the Medical Oncology Development/CMO and will be involved in high level strategic planning as well as hands-on responsibilities to support the growing pipeline. This person will serve as the primary clinical lead for our global clinical trials in Europe, USA & Asia from protocol synopsis development through study execution to completion of study reports, working closely with cross-functional areas, CROs, and Investigators.

Your primary responsibilities include:

  • Accountable and responsible for overall trial/program planning and execution adhering to the aligned timeline and budget.
  • Review, manage, proactively challenge and control project budgets and provide status updates to relevant stakeholders.
  • Develop protocol synopsis, clinical protocol, execution, and data analysis
  • Manage, build, and lead a clinical development and operations team to execute and achieve functional responsibilities and program goals with high quality in compliance with GCP, ICH, Alentis process and other global regulatory requirements
  • Interface with the regulatory and clinical CROs, supporting the completion and approval of study-related documents including for regulatory authorities, ethics committees, and other related study documents such as study reports
  • Lead efforts to identify, build relationships and communicate with key investigators and trial sites
  • Interact with clinical experts and clinical staff in the Asia pacific area
  • Direct study design, protocol development, and execution of clinical research studies
  • Contribute to the overall clinical strategy of the clinical development programs and product pipeline as well as giving in-depth clinical development advice on potential new projects (internal and external)
  • Contribute to early and strategic operational planning of indication(s) and program/trial feasibility assessment and strategic region/country allocation including scenario planning and risk management.
  • Generate/review clinical components of key documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned programs, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
  • Ensure quality of all clinical documents (e.g., Investigators’ Brochure, protocols, study reports, clinical components of regulatory submissions, safety related documents)
  • Provide scientific clinical input to study-related documents and analysis plans including Informed consent forms, clinical research forms , statistical analysis plans , clinical pharmacology analysis plans , clinical study reports and publications.
  • Analyze and interpret data expertly, and clearly communicate results both internally and externally
  • Act as primary Medical Monitor, monitoring the safety of enrolled subjects on assigned trials
  • Drive operational excellence through process build-up and optimization to fit in Alentis pipeline needs.

Your required experience and skills:

  • Master’s degree in the biological sciences
  • 10+ years of clinical development experience in a pharmaceutical company covering early clinical trials
  • Sound knowledge and understanding of early phase clinical trial and global regulatory requirements
  • 5+ years of clinical development experience within oncology is mandatory
  • Sound experience with GCP/ICH/FDA, HongKong, Singapore, China requirements, clinical trial designs and development strategies
  • Project management experience in a pharmaceutical company is required
  • Ability to develop and maintain relationships with significant KOLs and thought leaders, especially in the Asia pacific area
  • Very good communication skills in English and Mandarin, written and verbal is a given
  • Excellent planning and strong organizational skills, able to manage multiple tasks simultaneously and set priorities
  • Excellent conceptual thinking, which is used to approach and solve complex issues and their implications
  • Self-motivation and able to work independently in a fast-pace, small company environment
  • Excellent interpersonal and negotiation skills
  • Pro-active, goal-oriented and problem-solving attitude
  • Personal resilience, perseverance, energy and drive
  • Team player, open personality and collaborative attitude

What we offer:

  • The opportunity to contribute to the development of First-In-Class molecules in an innovative leading Biotech environment in the field of fibrosis and oncology
  • Competitive compensation for your work and flexible working environment

If your profile matches the above description, please send your CV and motivation letter by email to: career@alentis.ch