Senior Principal Scientist, Clinical Development, Clinical Pharmacology

Location
Boston, MA
Posted
Jun 29, 2022
Ref
Req #130
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Boston, MA, USA ● Vancouver, BC, Canada Req #130 Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders. 

At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.

Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us.  We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.

We are seeking a Senior Principal Scientist, Clinical Development, Clinical Pharmacology to join our team. The Senior Principal Scientist will be a key member of Xenon’s Clinical Development department and highly collaborative Clinical Development team, with involvement in a diverse range of activities. As a key focus, the Senior Principal Scientist will manage the preparation and updating of comprehensive Clinical Pharmacology (PK) Plans for assigned products, lead the preparation of clinical synopses and author and/or review a variety of clinical trial and regulatory documents, and be a key contributor to the interpretation of clinical data supporting clinical pharmacology throughout development from first in human to marketing applications.


The role is hands on, requires frequent cross-functional collaboration, and excellent working relationships with many internal groups, including, for example, Biostatistics, Translational Drug Development, Clinical Operations, Regulatory, and Senior Executive Management. The incumbent will also help establish and maintain external relationships with Key Opinion Leaders (KOL) and other experts to ensure appropriate input is sought at all stages of clinical development.


This position initially reports to the Senior Director, Clinical Development and will be located in either the Vancouver, BC, Canada or Boston, MA, USA location; we may consider other locations for an exceptional candidate.


RESPONSIBILITIES:

  • Contribute to the preparation and on-going revisions and strategy of Clinical Development Plans for assigned products and product candidates, collaborating with other key internal functions including Translational Drug Development, Biostatistics, Clinical Operations, Regulatory, Medical Affairs and Commercial; provide strategic and scientific leadership for trial designs, both standard and novel for both large and rare disease indications.
  • Lead and manage clinical pharmacology studies, including design and oversight of pharmacokinetic studies throughout clinical development stages in collaboration with internal colleagues.
  • Review scientific literature and develop product and indication knowledge to understand and effectively communicate information relating to products, product candidates and therapeutic areas.
  • Serve as clinical pharmacology expert to provide scientific input into the development, execution, and communication of clinical trial(s).
  • 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.
  • In collaboration with internal colleagues, identify and build relationships with KOLs and other experts to gain scientific and medical input on a variety of topics related to clinical development.
  • Draft and/or review clinical and scientific sections of regulatory submissions, including INDs and NDAs, and discussion documents for interactions with regulatory and Health Authorities.
  • Draft and review documents (including Investigator Brochures, clinical study protocols, and clinical study reports and regulatory submissions), as well as scientific publications (incl posters, abstracts, and manuscripts).
  • Participate in the review and interpretation of clinical trial data and provide insight into the clinical relevance of trial results.
  • Provide analyses of development strategies and options for discovery pipeline programs, including input into Proof-of-Concept trials, biomarker approaches, etc.
  • Support in-licensing and out-licensing activities and partner relationships as needed.
  • Present proposals and plans to variety of audiences, including to the Company’s Senior Executive Team.
  • Contribute to the development of short- and long-term goals for the department in accordance with overall Company and Development strategies.
  • Participate in the planning and management of budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
  • Other duties as required from time to time.
  • Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.


QUALIFICATIONS:

  • MD or PhD with a minimum of 15 years of progressive clinical development experience at a pharmaceutical or biotechnology company; a minimum 12 years of management experience preferred.
  • Broad experience in clinical trial design with specific expertise in pharmacokinetics and clinical pharmacology data interpretation.
  • Working knowledge of FDA and EMA regulatory landscapes, GCP, ICH guidelines, and all phases of clinical drug development.
  • Demonstrated expertise in clinical pharmacology studies across therapeutic areas.
  • Excellent verbal communication and presentation skills.
  • Ability to lead interactions with clinical pharmacology focused CROs and Phase 1 units.
  • 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.