- Set the overall global development strategy and plan for the current and future pipeline programs, including preparation of regulatory submissions and commercial planning.
- Lead and drive the decision-making process for advancing development drug candidates based on potential for meaningful clinical impact for patients and high potential commercial value.
- Prioritizes development project resources across the portfolio aligned with the corporate strategy and goals. Ensure clinical programs are scientifically, medically and statistically sound, cost effective, delivered on time, and executed in accordance with good clinical practice standards.
- Serve as the principal physician and clinical spokesperson for the company and will interface with health authorities (e.g. FDA, EMA), clinical research investigators, key opinion leaders, patient advocacy groups, investors, and business development and partnering representatives.
- The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others.
- Stay abreast on the relevant emerging medical landscape. Serve as the resident medical expert and advisor to the CEO, the Board of Directors, and the rest of the Executive Management team on strategic medical issues
In terms of the performance and personal competencies required for the position, we would highlight the following:
Setting Strategy - The ability to create and articulate an inspiring vision and related strategies to drive the vision for the organization, not only for the areas s/he is directly responsible for, but the enterprise as a whole.
Executing for Results - The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountability in driving results through execution and operational excellence.
Leading Teams - The ability to attract and recruit top talent, motivate others, delegate effectively, celebrate diversity within the team, and effectively manage performance by being a strong developer of others.
Relationships and Influence - Naturally connects and builds strong relationships and inspire trust with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively, engaging others to the greater purpose for the organization.
Required Education and Experience
- Doctor of Medicine Degree/Professor of Medicine Degree/PHD
- 15+ years of broad medical experience with an emphasis in medical education, experience, and thought leadership in liver disease or related therapeutic areas.
- Over 10 years of prior experience leading a team of medical professionals in the area of biopharmaceuticals;
- Over 10 years of prior experience in executive roles, managing the control and recruitment of top talent, team performance and goals set-up while committing the organization to improved performance;
- Broadly skilled drug developer with evidence of strategic, tactical and operational leadership success.
- At least 15 years in liver disease, hepatology, gastroenterology or rare disease. Preference for candidates with experience in inflammatory liver disease, including cholestatic diseases.
In addition to the above, we require prior experience with:
- Over 15 years in novel biology,
- Over 10 years in rare disease clinical indications,
- new therapeutic modalities,
- Influencing and interacting with regulatory pathways to approval (e.g., FDA)
- Excellent knowledge of late-stage development, Medical Affairs and
health authority interaction is required.
- Knowledge of early-stage development and translational medicine is a strong plus.
From a technical perspective:
- a demonstrated success in advancing programs from proof-of-concept through late-stage development, and
- substantive experience leading and/or contributing to BLA or NDA and/or supplemental submissions, including interacting and negotiating with FDA and EU regulatory officials.
Prior experience as a public company Chief Medical Officer is desirable, but not required, as preference will be given to the candidate with the most overall medical training, drug development experience, experience working with FDA regulatory processes, leading teams, overall operational management experience at a senior level, etc.
The successful candidate will be broadly skilled drug developer with evidence of strategic, tactical and operational leadership success.
Ability to Supervise
More than 20 people, Committees, Staff in various areas of responsibility, Contractors
Valid driver's license, Own vehicle, Willing to travel, Willing to travel overnight, Willing to travel regularly, Willing to travel internationally, Travel expenses paid by employer
Budgetary Responsibility – over $8,000,000
Business Equipment and Computer Applications
MS PowerPoint, MS Office, MS Word, MS Excel, MS Outlook, MS Windows
Median level typical Canadian benefits for a public company.
Will include :
- extended medical benefits
- dental insurance
- eye care insurance
- life insurance
- disability insurance
- annual corporate bonus
- other benefits
Terms of the position: Full-time, permanent position with 40 hours per week
Work location address: 1 Dundas St. West, Suite 2500, Toronto, ON, M5G 1Z3
Company business address: 7575 Gateway Blvd, Ste 110, Newark, CA 94560 USA