We are seeking a Director/Senior Director, Clinical Science to join our team.
The Director/Senior Director, Clinical Science will report to the VP of Clinical Development and will be a key member of Xenon’s Clinical Department. S/he will provide scientific input into clinical development plans, trial designs and regulatory documents for a number of products at varying stages of development. The role is hands on, requires frequent collaboration and excellent working relationships with various internal groups (Preclinical, Clinical and Executive Management) and the incumbent will play a key role in helping establish and maintain external relationships with Key Opinion Leaders (KOL) and other collaborators to ensure appropriate input is sought at all stages of clinical development.
RESPONSIBILITIES:
- Review scientific literature and develop product and indication knowledge to understand and effectively communicate information relating to pipeline products and therapeutic areas
- Maintain a high degree of awareness of the external research and regulatory environments and track emerging study data to ensure appropriateness of clinical development plans and trial endpoints
- Demonstrate expertise in clinical trial endpoints, including patient reported outcomes, across therapeutic areas
- Identify and build relationships with KOLs to promote scientific discussions
- Assemble expert panels and take the lead in management and hosting of advisory boards, and other scientific consultant meetings to advise on clinical development
- Provide strategic, scientific and/or medical input into clinical development plans for all phases of clinical development
- Provide strategic and scientific leadership for novel trial designs that might be optimal for rare disease indications
- Collaborate with pre-clinical colleagues to assess PK and PD to support the clinical development plan
- Provide scientific input to regulatory documents for submissions/discussions with Health Authorities
- Lead development of Investigator Brochures
- Lead development of clinical study protocols and clinical study reports
- Participate in the review and interpretation of clinical trial data, and provide insight into the clinical relevance of trial results
- Contribute to development of publication plan and clinical data communication
- Draft / provide input into scientific publications (posters, abstracts and manuscripts)
- Collaborate with Strategic Alliances to develop stage appropriate assessments
- Provide analyses of development strategies and options for discovery pipeline programs including early Proof-of-Concept trials and biomarker approaches.
- Lead and coordinate internal evaluation of in-licensing opportunities
QUALIFICATIONS:
- MD or PhD
- A minimum of 6 years of clinical experience at a pharmaceutical or biotechnology company
- Broad experience in clinical trial design (phases 1 to 3) and clinical data interpretation
- Expertise and a track record in epilepsy desirable
- Working knowledge of FDA and EMA regulatory landscapes, GCP, ICH guidelines and all phases of clinical drug development (e.g. preparation of meeting requests, regulatory response documents, safety reporting)
- Excellent verbal communication and presentation skills.
- Well-developed writing skills that can be applied to a wide range of scientific documents
- Strong ability to work collaboratively in dynamic small teams of internal and external partners that are a part of a fast-paced environment.
To apply for this position, please e-mail your resume and cover letter to careers@xenon-pharma.com and include “Director/Senior Director, Clinical Science” in the subject line. All attachments must be saved as one file and be named: “Your Full Name – Director/Senior Director, Clinical Science.” We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
