We are a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing – both independently and with our pharmaceutical collaborators – a novel product pipeline of ion channel modulators to address therapeutic areas of high unmet medical need, such as pain and epilepsy.
We are seeking a highly motivated physician who can contribute scientifically, operationally as well as strategically to our efforts. This individual will report to the CMO and will be a member of the senior management team. This role requires an individual who has outstanding scientific vision and exceptional leadership ability, as well as a strong working knowledge of all phases of clinical drug development. The individual will actively participate with our partners and will be responsible for clinical trial design and oversight of medical monitoring. The ideal candidate will be open to new challenges, be flexible, a creative problem solver, a risk-taker with integrity and personal accountability, have a strong commitment to developing novel treatments and thrive in an entrepreneurial environment. This is a hands-on role and will be required to build excellent working relationships with various internal groups. This position can be based in Burnaby, BC or Boston, MA.
• 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, including novel optimized trial designs for rare disease indications
• Collaborate with preclinical colleagues to assess the need for and design of appropriate preclinical experiments to support the clinical development plans
• Provide scientific input to regulatory documents for submission and discussions with the Health Authorities
• Lead the development of Investigator Brochures, clinical trial 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 the development of publication plans and clinical data communications
• Draft/provide input into scientific publications, such as posters, abstracts, presentations and manuscripts
• Collaborate with strategic alliances to develop stage-appropriate assessments
• Analyze 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
• Prepare, manage and implement clinical development plans for the development of company’s products.
• Oversee all medical components of the drug development process
• Interact and present to the Senior Executive Team and Board of Directors strategic plans as programs execute.
• M.D. with extensive experience in neuroscience.
• Minimum of 8 years of clinical experience in a pharmaceutical or Biotech environment.
• Solid drug development background with experience in filing IND’s and bringing novel therapeutics into clinical development.
• Experience in the design and execution of clinical trials used to demonstrate safety and efficacy.
• Effective communicator with strong written and verbal communication skills.
• Understanding of clinical trial operations, biostatistics and data management techniques.
• Good understanding of clinical pharmacology principles.
• Working knowledge of health authority regulations regarding the evaluation and approval process.
• Ability to travel up to 30%.
• Possesses excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
• Be science and data driven.
• The ability to work as part of a small team, both in a leadership role and as a contributing member is essential.
• Creative problem solving skills.
• Flexibility of thought and an openness to new ideas.
• The ability to motivate and maintain a positive work environment is vital.
• As appropriate, is able to easily delegate work, promote cooperation amongst the staff and resolve conflicts in a manner which encourages good work relations.
• Fluent in written and spoken English.
• Willingness to travel domestically and internationally as required; travel to head office will be required from time to time if candidate is not based in Burnaby, BC.
To apply for this position, please e-mail your resume and cover letter to firstname.lastname@example.org and include “Director/VP, Clinical Science” in the subject line. All attachments must be saved as one file and be named: “Your Full Name – Director/VP, Clinical Sciences.” We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
Location/Region: Boston, MA (US)