VP, Clinical Development
[ March 11, 2019 ]
We are seeking a VP, Clinical Development to join our team. Reporting to the Chief Medical Officer, the Vice President, Clinical Development develops strategy and oversees the planning and execution of non-clinical GLP programs and all phases of clinical development (Phases 1-4) for the Company’s products and product candidates. The Vice President leads and manages key functions and staff in Clinical Sciences, Clinical Operations, Biometrics, Medical Writing, and Non-Clinical Research in a highly collaborative, team based environment. Depending on experience, the Vice President may on an interim basis, provide oversight to the Medical Monitoring, Regulatory and Quality functions and staff.
The Vice President will have outstanding scientific vision and exceptional leadership ability in a fast paced, multi-location environment. The Vice President will interact with all levels of internal staff as well as external stakeholders, including, but not limited to the Company’s Board of Directors, the FDA and other health authorities, Key Opinion Leaders, Advisory Boards and Committees, potential partners, and CROs. This position will be located in Burnaby, BC, Canada or the Boston, MA, USA area.
- Develop and propose clinical development plans for the Company’s portfolio of product candidates from Phase 1 through Phase 3, New Drug Application(s) and post approval studies in compliance with global regulatory standards and in collaboration with other key functional areas, external vendors and advisors
- Oversee and manage the execution of non-clinical and clinical programs, including trial design, operations, and analysis in accordance with strategic plans and regulatory requirements through reporting departments and external vendors and advisors
- Develop and maintain a high degree of awareness of on-going research and scientific literature and ensure the tracking of emerging study data relevant to the Company’s portfolio; recommend changes to Clinical Development plans as appropriate
- Act as an author and/or reviewer of key documents and others types of submissions and communications to global health authorities; act as a domain expert to represent the Company at meetings with global health authorities
- Act as an author and/or reviewer of key documents and other forms of communication to the scientific and medical communities, including papers, posters, presentations and other forms of intellectual property
- Represent the Company at scientific and medical meetings, including, for example, Investigator Meetings, Advisory Board, and other interactions with Key Opinion Leaders
- 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 and other employees in Non-clinical, Clinical Science, Clinical Operations, Biometrics and Medical Writing 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 employees in reporting and other departments
- M.D with a minimum of 15 years clinical development experience neuroscience in a pharma or biotech environment
- Deep and broad experience in all aspects of Phase 1 to 3 clinical trial design, execution and data interpretation in both efficacy and safety; ideally has had a lead role in NDA preparation and defense
- Experience in CRO selection, contracting and management
- Working knowledge of some or all of clinical pharmacology, biostatistics, data management, and global regulatory strategies
- Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company
- Proven ability to build and develop high performing teams; excellent delegation and conflict resolution skills
- Be science and data driven while at the same time, creative and flexible in strategic thinking and problem solving
- Ability to travel up to 30%, both domestically and internationally
To apply for this position, please e-mail your resume and cover letter to firstname.lastname@example.org and include “VP, Clinical Development” in the subject line. All attachments must be saved as one file and be named: “Your Full Name – VP, Clinical Development.” We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.