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A Range of Possibilities

Therapeutic Area Head I and I - Early Development

date posted 08/15/2022
contract type Full time
job id R2646012
location Chilly-Mazarin;

The Therapeutic Area Head provides PV expertise, leadership, mentorship, and supervision of involved Therapeutic Area members and GPV 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 TAH is the key accountable contact to internal and external stakeholders.

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 TAHs 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

Skills and Responsibilities

  • 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)

Formal Education And Experience Required:

  • 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

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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