Ablynx

Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company, with Headquarters in Ghent, Belgium, began operations in 2001 and currently employs over 200 employees. Ablynx is developing a portfolio of Nanobody®-based therapeutic programmes in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Wyeth Pharmaceuticals, Novartis and P&G Pharma.

Translational Medicine and Clinical Pharmacology

This position is in the global department responsible for Translational Medicine and Clinical Pharmacology across all of the therapeutic areas at Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, and nucleic acid modalities. The individual in this position is an integral part of the therapeutic area project teams, often leading the cross-functional Translational Medicine Subteam from preclinical development through post-marketing. A key focus of this role is the path from the research phase through early clinical development including rapid Proof-of-Concept, as well as experimental medicine studies to evaluate the pharmacology of novel therapeutic approaches. Collaborative interactions with laboratory research scientists, toxicologists, pharmacokineticists, modeling and simulation experts, biomarker experts, and late phase therapeutic area clinicians are critical to success in the role. The ability to integrate the outputs of multiple disciplines into a coherent translational medicine plan is essential.

 

This position requires substantial experience and expertise, as it will also entail mentoring and guidance of more junior translational medicine staff members and members of collaborating departments.

At the project level, the individual will be a member of the translational medicine subteam and in specific cases may lead this subteam and participate on the project core team. In these roles, duties include:

• Participate in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.

• Review, interpret results, and author translational medicine and clinical pharmacology-related clinical documentation, including: clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology components of investigator brochures, regulatory documents.

• Interacts effectively with managers from various disciplines; serves as expert and internal consultant on assigned area and liaises with partners on projects.

• Coordinates the translational medicine subteam meetings.

• Coordinates activity of the clinical study director of assigned project(s).

• Participates in the dose selection for first-in-human studies, Go/No Go decisions when needed.

• Ensures an adequate follow-up of studies and project timelines.

• Communicates project team discussions of interest to the other group members who are involved with the project.

• Presents data in appropriate meetings (inside or outside the Group).

Interactions:

• Internal: Scientists, clinicians, and project leaders in therapeutic areas, clinical trial managers, data managers, study biostatisticians, representatives from Regulatory Affairs, Safety & Toxicology, Global Pharmacovigilance & Epidemiology (GPE)

• External: investigators, clinical experts, clinical research organizations, health authorities.

 

Major Challenges and opportunities:

-Communication of the role of the department; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative attitude.

-Takes an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.

-Ensures Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication.

-Ensures high quality documents, requiring strong writing and communication skills.

-Manages aggressive timelines effectively through cross-functional planning.

 

Key Internal/External Relationships:

Internal contacts: Clinical trial operations, data management coordinators, group leaders, department head. External contacts: Company departments and enabling functions. Outside the company: clinical research organizations, academic research organizations, clinical trial vendors, hospitals, ethics committees, clinical and scientific experts.

 

Decision Making Authority:

Makes front-line decisions on protocol design, execution, dose escalation and safety, information for regulatory authorities.

At the clinical study level, the individual will also serve as Clinical Study Director for selected clinical studies. Clinical Study Director principal duties and responsibilities include:

Study preparation:

• Designs, and conducts early clinical development studies within planned timelines (supported by an operational team).

• Reviews and approves study documentation (case report forms, monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).

• Coordinates clinical team to set-up and follow the study.

• Ensures proper documentation is provided to the Ethics Committees and Health Authorities.

Study conduct:

• Ensures that the study is scientifically sound and correctly conducted.

• Prepares and reviews the interim investigator reports.

• Provides documents for making decision to start next dose level.

• Reviews the Serious Adverse Event reports.

Study validation and reporting:

• Participates in the data review and validation meetings before database lock.

• Reviews and interprets the results.

• Prepares and distributes the Key Results Memo and reviews the Clinical Study Report.

Interactions:

• Internal: scientists, clinicians, and project leaders in therapeutic areas, operations group (clinical trial managers), data managers, study biostatisticians, representatives from Regulatory Affairs, Safety & Toxicology, Global Pharmacovigilance & Epidemiology .

• External: investigators, clinical experts, clinical research organizations.

 

Basic Qualifications:

  • Advanced degree: M.D. or M.D./Ph.D with at least 5 years of research experience in industry and/or academia, of which at least 3 years were focused on clinical or translational research
  • Knowledge of clinical trials in early development phases
  • Broad biomedical knowledge base
  • Knowledge and mindset in translational research

 

Preferred Qualifications:

  • Postgraduate clinical training
  • Experience in First-in-Human clinical trials

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