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Therapeutic Area Lead - United States  

Aequor Technologies (company)

Posted on : 22 December 2017

Project Description

The Therapeutic Area Lead (TAL) provides PV expertise, leadership, mentorship, and supervision of involved Therapeutic Area members and GPE personnel assigned to the respective organization to ensure appropriate assessment of Safety information related to all Sanofi products through the management of all medical, scientific and administrative responsibilities.
The TAL is the key accountable contact to internal and external stakeholders.

Knowledge and Skills:
Excellent knowledge of PV and medical safety
Good working knowledge of risk management and signal detection
Interaction with key regulatory agencies, submission experience including the preparation of dossier, and experience in post-marketing and clinical development PV
Experienced in people management with proven proficiency in organizational and planning capabilities
Demonstrated leadership ability in the pharmaceutical industry with proven ability to succeed in multidisciplinary teams; proven ability to motivate, problem-solve, prioritize, take initiative, and meet challenges
Excellent clinical judgment
Capability to synthesize and critically analyze data from multiple sources
Ability to communicate complex clinical issues and analysis orally and in writing
Able to develop and document sound risk assessment
Demonstrates initiative and capacity to work under pressure
Ability in change management
Demonstrates leadership within cross-functional team environment
Excellent teamwork and interpersonal skills
Fluent in English (written and spoken)

M.D. Degree, Board Certified, Board Eligible or equivalent in relevant clinical specialty
Minimum of 12 years total experience in PV and/or relevant medical field or equivalent, including a minimum 5-7 years of international pharmaceutical activities (such as Research & Development, Medical affairs)
Minimum 5 years supervisory/ management experience or equivalent in matrix organization with proven proficiency in organizational and planning capabilities is desired

Management responsibilities:
  • Leadership and management of Global Safety Officers (GSO) and administrative assistants
  • Prioritization and resource allocation
  • Ensure that the Therapeutic Area objectives are achieved and compliance goals are met according to regulatory requirements and company standards
  • Oversee safety strategies, decision-making, and escalation of issues (submission activities, ad-hoc responses, crisis management, advisory committees, product alerts, etc.)
  • Ensure alignment of Therapeutic Area objectives, safety strategies and issue escalation with PV head
  • Foster communication and collaboration with other TALs to standardize best practices
  • Oversee continuous evaluation of safety and benefit risk assessment activities and strategies for the Therapeutic Area
  • Develop and support processes that ensure state-of-the-art PV contributions
  • Support for other therapeutic area teams and deputise for the PV Head if required

Internal and external safety expertise:
  • Function as a core member of the safety governance
  • Set medical, scientific and PV standards for the Therapeutic Area
  • Provide PV expertise within the Company as the therapeutic area's senior representative
  • Maintain Therapeutic Area expertise, product portfolio-specific expertise and ongoing assessment of therapeutic areas, competitive drugs and therapies and applicable regulations

Strategy determination and interactions:
  • PV representative to Therapeutic Area review committee for strategic portfolio determination
  • Interfacing with cross-functional groups and with external companies and authorities (strategy alignment, safety communication, etc.)
  • Interact with clinical development, regulatory, preclinical, labeling, clinical operations, medical writing, legal, medical affairs, and review and governance committees, as well as external Company partners, and regulatory authorities
  • Interact with other departments to resolve disagreements in project teams regarding safety management
  • Leadership and advocacy to ensure appropriate and standardized communication regarding product safety assessment between GSOs and other functions including Medical
  • Affairs, Country Leads, and Regional Heads

Team development:
  • Supervise, mentor and develop new and existing physicians, and other staff in the functional therapeutic area
  • Lead regular team meetings to further transparency on strategic decisions, goals and objectives. Schedule frequent peer review sessions to foster improvement of critical reasoning and debating skills
  • Ensure training of all Therapeutic Area staff in PV expertise, Therapeutic Area knowledge, communication skills, and professional competencies
  • Manage the team in developing a high level of team spirit and motivation
  • Promote exchange of best practices and lessons learned within the team and across other groups/ functions
  • Manage talents (Identify, attract, develop, and maintain qualified staff) for the global success of the group

Budget Management:
  • Define planning of deliverables and associated budget for Therapeutic Area consistent with the guidelines provided by the PV Head
  • Ensure the Therapeutic Area stays within defined expense goals