Vice President, Clinical Development (Pain)

Xenon Pharmaceuticals•Needham, MA

13d•$412,600 - $433,200•Hybrid

About The Position

Xenon Pharmaceuticals is seeking a Vice President, Clinical Development (Pain) to lead all aspects of the development of the company’s pain program’s, including the current Phase 2 and future Phase 3 programs across both the Kv7 agonist and Nav 1.7 inhibitor programs. The Vice President, Clinical Development will be responsible for therapeutic development expertise in pain and will establish and maintain relationships with key internal stakeholders across the organization, including, but not limited to Biostatistics, Data management, Pharmacovigilance and Drug Safety, Trial Operations, Medical Writing, Regulatory, Quality, Medical Affairs and Commercial and key external stakeholders, including Clinical Research Organizations (CROs), key opinion leaders (KOLs), and Health Authorities. This position reports to the Senior Vice President, Clinical Development and will have flexibility to be based out of Boston, MA or remote locations. Boston based candidates will require a minimum of two onsite days per week.

Requirements

MD with experience in pain drug development
Minimum of 12 years of clinical experience in a pharmaceutical or biotech environment
Minimum of 5 years of experience as a drug development program lead and/or managing teams
Possesses excellent leadership, managerial and interpersonal skills; should have proven skills as an effective manager, and demonstrate the ability to lead a cross-functional development team
Strong drug development background with experience in filing IND’s, NDAs and bringing novel therapeutics into clinical development
Experience in the design and execution of pain clinical trials used to demonstrate safety and efficacy
Broad experience in clinical trial designs (Phases 1 to 3) implementation, execution, and clinical data interpretation
Training in GCP and knowledge of the research process, of the importance of adherence to protocols, and of the accuracy needed in collection and documentation of research data
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 engender credibility and confidence within and outside the company through scientific acumen and leadership skills; 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
Adherence to the highest ethical standards
Effective communicator with strong written and verbal communication skills
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
Strong team organization and delegation skills, promotes cooperation amongst the staff and resolve conflicts in a manner which encourages good work relations

Responsibilities

Develop and propose the clinical development strategy in all pain development programs in compliance with global regulatory standards and in collaboration with other key functional areas, external vendors, and advisors
Collaborate with Program Management to run efficient and productive drug development program teams across all pain drug development programs
Provide scientific and drug development expertise to the cross-functional development team through due diligence of scientific literature and indication knowledge
Maintain a high degree of awareness of external research and regulatory environments and track emerging study data to ensure the appropriateness of clinical development plans
Identify and build relationships with KOLs to promote scientific discussions in accordance with overall KOL engagement strategies and plans
Assemble expert panels and take the lead in management and hosting advisory boards, and other scientific consultant meetings to advise on clinical development
In collaboration with Drug Safety and Pharmacovigilance, establish and manage DSMBs as required
In collaboration with Drug Safety and Pharmacovigilance, oversee the analysis of any potential safety events within a given study and across studies
Participate in the review and interpretation of clinical trial data and provide insight into the clinical relevance of trial results
Provide scientific input to regulatory documents for all submissions and discussions with the Health Authorities
In collaboration with Medical Affairs, contribute to the development of publication plans and clinical data communications
Interact with and present to the Executive Leadership Team and Board of Directors on program strategic plans as programs execute
Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans
Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies
Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices
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
Willingness to travel domestically and internationally as required (up to 30% of time)
Other duties as assigned