Ra Associate Director (Clinical Expertise)

About Knight

Knight Therapeutics Inc. is a pan-American (ex-US) specialty pharmaceutical company focused on acquiring, in licensing, marketing, and commercializing innovative prescription pharmaceuticals in Canada and Latin America. Knight owns Biotoscana Investments S.A., a pan-Latin American specialty pharmaceutical company. Knight Therapeutics Inc.’s shares trade on TSX under the symbol GUD. Headquartered in Montreal, Knight has over 700 employees globally.

Position Summary

Reporting to the Director of Regulatory Affairs, the RA Associate Director (Clinical expertise) will assume global responsibilities within the Regulatory Affairs department to contribute to the assessment of new business partnerships/acquisitions as well as opportunities arising from the current portfolio, to leverage medical and clinical evidence. This position covers Canada and LatAm, in collaboration with corporate partners. The ideal candidate is highly organized, has flexible and adaptable communications capabilities, demonstrate good problem-solving skills and can adapt to changing priorities.

This is a full-time position for a Montreal-based candidate.

Specific Responsibilities

• Preparing scientific position papers, briefing books, and supporting pre-submission meetings related to medical-clinical information to be presented to the health authorities.
• Contributing to the analysis of available literature to enhance product indications.
• Providing clear directives to achieve a balance between regulatory concerns, marketing objectives, compliance, time to market, and costs.
• Evaluating the feasibility of registering potential new indications based on ongoing studies.
• Interpretation of bioequivalence results.
• Contributing to the analysis of potential agreements from the medical-clinical perspective regarding the product in question, understanding the strengths and weaknesses of non-clinical and clinical studies from the viewpoint of health authorities.
• Proposing new opportunities to enhance the product monograph from a regulatory perspective, considering treatment lines, combined therapies, and local standard of care.
• Assessing any necessary complimentary studies for registration in the case of incremental innovative products.
• Comprehending, from the perspective of access and price regulation, the opportunities concerning products in the portfolio.

Characteristics of a Good Candidate

Analytical and Organizational Skills

The candidate must have good analytical skills with high-level attention to detail and commitment to accuracy and depth.

Negotiation skills / Teamwork

The candidate must have good interpersonal skills and demonstrate flexible and adaptable communications capabilities with partners inside and outside the country, as well as with regulatory authorities. She/He must have the ability to motivate, lead, and grow a regulatory affairs team.

Ability to Multitask

She/he must be able to effectively function in a fast-paced, people oriented, team environment where priorities may shift. She/he will be able to handle multiple projects at a time.

Autonomy / Problem Solving

The candidate must work independently yet interact with various people. She/he must have the ability to identify important issues and identify solutions in a timely manner.

Dealing with Ambiguity

The candidate must demonstrate adaptability in situations involving constant changes and an ability to evaluate and properly adapt the documents supplied by corporate partners for Canadian regulatory requirements.

Candidate Profile

Required

Education:

· Advanced scientific degree (i.e. MSc, PharmD, PhD, MD) or MD, PharmD, PhD, MS in life science /or an equivalent combination of education or experience

Experience:

· Strong scientific knowledge

· Strong knowledge of the Canadian regulations and international regulations (LATAM regions), good ability to interpret policies and guidelines

· Excellent communication skills, written and oral in English is mandatory; and French proficiency is an asset

Other:

· Good knowledge of Microsoft Office Suite

Assets

· M.Sc. in drug development

· 7-10 years within the pharmaceutical industry, including managerial responsibilities.

· Knowledge of international regulations

· Spanish or Portuguese (written and oral)

· Project management tools

As illustrated in the description of the tasks, it requires, in particular, to communicate, verbally and in writing, with the other team members located across Canada as well as Latin America as well as customers across Canada. Following an assessment, we have therefore determined that the performance of these tasks requires the knowledge of the English language, in addition to the knowledge of the French language (written and spoken). We have also determined that the English knowledge already required from other employees is insufficient for the performance of the duties requiring the knowledge of English

To apply, please send your resume to: [email protected]

Only selected candidates will be contacted.