[Hiring] Senior Director, Responsible Pharmacist @Revolution Medicines

Role Description

The Senior Director, Head Pharmacist/Responsible Pharmacist guarantees the pharmaceutical responsibility of the laboratory as “exploitant” and assumes the role of "Responsible Pharmacist." Responsibilities include:

• Organize and supervise all pharmaceutical operations of the company or organization, including manufacturing, advertising, information, pharmacovigilance, batch monitoring and withdrawal, distribution, import and export of the drugs, products, objects or articles concerned, as well as the corresponding storage operations.
• Ensure that transport conditions guarantee the proper preservation, integrity and safety of these medicines, products, objects or articles.
• Acknowledge the files related to marketing authorization applications submitted by Corporate or organization and any other application related to the activities they organize and supervise.
• Participate in the development of research and study programs.
• Imperson authority over delegate and deputy pharmacists; approve their hiring and be consulted on their dismissal, except in the case of an army pharmacist-chemist.
• Appoint interim delegate pharmacists.
• Inform the other directors of the company or organization of any obstacle or limitation to the exercise of these powers.
• Implement all necessary means to comply with the obligations set out in articles R. 5124-48 and R. 5124-48-1.
• Ensure that the safety measures referred to in article R. 5121-138-1 have been affixed to the packaging in accordance with the conditions set out in articles R. 5121-138-1 to R. 5121-138-4.
• Notify the Agence nationale de sécurité du médicament et des produits de santé (ANSM) of any launching on the national market of a medicinal product which is considered to be falsified.
• Organize the quality system within the laboratory in accordance with French laws and regulations.
• Support the transversal activities carried out by the marketing, medical, compliance and market access departments.
• Participate in the deliberations of the management, administrative, executive or supervisory bodies, or those of any other body with an executive function, when these deliberations concern or may affect the performance of the tasks.
• Ensure compliance with professional ethics and all regulations issued in the interests of public health.
• Ensure that the responsibilities of pharmacists and staff under his/her authority are clearly defined.
• Ensure that pharmacovigilance cases are reviewed and processed within the appropriate timeframes.
• Immediately inform the French National Agency for the Safety of Medicines and Health Products of any prohibition or restriction imposed by the competent authority.

Qualifications

• Doctor in pharmacy and able to be registered as Responsible Pharmacist.
• Specialization in regulatory affairs and quality.
• Minimum 15 years of proven experience in leadership roles within the biopharmaceutical industry in the field of oncology.
• Fluency in both verbal and written French and English.
• Proven leadership and people management capabilities.
• High capacity of social competence for teamwork, coaching and situational leadership.
• Proven track record shaping and executing country strategy and influencing policy at a senior industry level.
• In-depth knowledge of the French pharmaceutical market and regulatory environment.
• Ability to create and nurture a strong culture of collaboration and authenticity.
• Proven success in building effective relationships with internal stakeholders, regional authorities, and vendors.
• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills.

Requirements

• Submission and obtaining the opening authorization application for the “Exploitant” pharmaceutical establishment.
• Filling and submission of the annual facility master file (once a year).
• Relationships with the Health competent authority – the French Agency for the Safety of Medicines and Health Products (ANSM).
• Participation in the management of early access programs.
• Monitoring of drug marketing.
• Validation of the Advertising and Medical Information process.
• Participation in pharmaceutical document archiving management.
• Implementation of the Regulatory Intelligence process.
• Supervision of pharmaceutical contracts.
• Regular audits of internal pharmaceutical activities.
• Implementation of a risk management approach.
• Participation in audits and inspections by authorities.
• Follow-up of batch release for distribution in France.
• Management of batch recalls.
• Management of shortages with the health authority.
• Storage and distribution management.
• Management of quality complaints.
• Implementation of procedures (SOP).
• Implementation of compliance with the French Charter of Promotional Information.
• Planning, execution and follow-up of audits.
• Implementation of KPIs for key pharmaceutical activities.
• Implementation of the local pharmacovigilance process.
• Nomination of local Qualified Persons responsible for Pharmacovigilance.
• Interaction with European Qualified Person responsible for Pharmacovigilance.
• Procedures and data management.
• Report to Competent authorities.
• Collection, registration, assessment, report and follow-up of adverse events.
• Screening of local scientific and medical literature for pharmacovigilance relevant information.
• Local Signal detection.
• Review and validation of Periodic Safety Update Report (PSUR).
• Reconciliation of shared PV data.
• Implementation of key performance indicators (KPI).
• Monitoring of product good use and off-label use.
• Implementation of medical information process in collaboration with the Medical information department.
• Collection, registration and response to medical information requests.
• Reconciliation of shared medical information data.
• Implementation of KPI.
• Promotional and non-promotional material review and approval.
• Implementation of a local training process for pharmaceutical and compliance processes.
• Review and validation of training material for commercial and medical teams.
• Validation of integration and ongoing staff training plans.
• Ensuring that all staff are trained in Good Practices.
• Competency assessment and empowerment of key personnel.
• Participation to implementation of French law about anti-bribery, transparency and compliance.
• Management of the Pharmaceutical Affairs Department in France.

Company Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.

• The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins.
• Current clinical development includes daraxonrasib (RMC-6236), elironrasib (RMC-6291), zoldonrasib (RMC-9805), and RMC-5127.