Talent.com
Global Project Head, Rare

Global Project Head, Rare

SanofiCambridge, MA, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Global Project Head -AATD

The Global Project Head (GPH) is delegated various responsibilities by the Senior GPH and / or Therapeutic Area Head to provide leadership, supervision, and coordination within the Global Project Team (GPT). The GPH position requires achieving results through others and supporting the senior management team in achieving corporate goals.

The GPH establishes the goals and will support staff within the program and participates in strategic planning for, and oversight of, the development activities of his / her area of responsibility. The GPH will be delegated such responsibilities as interaction with regulatory / health authorities (HA), approval of documents and product label, as appropriate. In addition, the GPH will be responsible for the communication strategy and scientific disclosures, travel authorizations, expense reports and other documents related to the GPT's work, and will interact with opinion leaders and consultants.

The GPH plays a role in several stages of drug development and helps assure that the group's priorities are aligned with the strategic priorities of the R&D Organization and the Business Unit.

Some of the GPH's core job responsibilities include those listed below, as well as all other duties assigned.

Scientific and Technical Expertise :

  • Has and maintains deep scientific, technical and clinical expertise in the specific therapeutic area
  • Understands and keeps updated with the clinical, clinical pharmacology, pre-clinical, and quality data relevant to the molecule of interest
  • Critically reads and evaluates relevant literature with deep understanding of the data and status from competitive products
  • Interacts with internal and external stakeholders
  • Owns the overall program strategy and leads the international cross functional team to meet program objectives
  • Proposes strategies for interactions with HAs
  • Participates in life cycle management strategy planning in collaboration with marketing teams
  • Establishes project goals in alignment with functional resource allocation, goals and objectives
  • Ensures operational plans are integrated across all functions
  • Oversees development planning, execution and budget in cooperation with relevant team members

Management and Career Development :

  • Ensures that direct reports are adequately qualified and trained in the task they are required to perform. Works cross functionally to select appropriate team members
  • Sets team's objectives, and works closely with direct reports to create individual performance and development goals
  • The Major Duties and Responsibilities Which the Position Is Accountable For Include :

  • Defines program strategy, target product profile, and target value proposition with all key stakeholder in GPT and Global Brand Team (GBT)
  • Defines global project plans and regulatory strategy together with the GPT members; leads the implementation of the global clinical plans and / or life-cycle management clinical development plans and post-marketing commitments aligned with the Target Product Profile, registration and market access objectives across regions
  • Responsible for ensuring the input from the platforms and the elaboration of a clear mandate to ensure deliverables against the agreed clinical plans
  • Working in matrix with cross-functional R&D and CMC functions he / she ensures deliverables of preclinical, clinical and quality studies needed for development and registration
  • Responsible for the regulatory documents / registration dossier, answers to HA questions, labeling negotiations with HAs, and labeling enhancement together with the GPT members
  • Ensures timely submission and dissemination of clinical and scientific data together with GPT members from all relevant functions
  • Management and delegation of interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups, internal stakeholders and decision boards and alliance committees)
  • Work in collaboration with alliance partner to ensure program strategic alignment across indications, as appropriate
  • Chair Joint Development Committee, and represent team at Joint Stirring Committee for all key decision making with Alliance partner, as appropriate
  • Contributor to R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs, as Active member of GPT.
  • Contributor to publication strategy with Medical Affairs and communication plans with Commercial and Investor Relations.
  • Direct management clinical lead.
  • Matrix leadership and dotted-line management toward all GPT members, including e.g. project management, clinical operations, regulatory, safety, translational medicine, statistics, CMC, I.A.
  • Basic Qualifications :

  • Medical doctor or doctor / scientist
  • More than 5 years of clinical or scientific, or more than 10 years industry, experience within the field of the specific therapeutic area compounds; pulmonary experience a plus
  • Fluent in English (verbal and written communication)
  • Preferred Qualifications :

  • Strong scientific and academic background with deep understanding of the disease
  • Experience in or demonstrated evidence for the capacity to lead and manage groups of professionals
  • Strong leadership skills to manage international, cross-functional teams of highly skilled professionals
  • Good networking ability in cross-cultural environment.
  • Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
  • In depth knowledge of global drug development activities including the development of other health care solutions along the whole value chain from research up to market access. Skilled in project and / or budget / resource management
  • Strategic thinking in combination with understanding science and technologies
  • Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
  • Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills
  • Embraces Sanofi's values, vision and mission
  • AATD - alpha 1 antitrypsin deficiency
  • Why Choose Us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.
  • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
  • 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.

    #GD-SA ? #LI-SA #LI-Hybrid #vhd

    serp_jobs.job_alerts.create_a_job

    Global Head • Cambridge, MA, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Global Head of Total Rewards

    Global Head of Total Rewards

    Galderma Pharma S.ABoston, MA, United States
    serp_jobs.job_card.full_time
    Global Head of Total Rewards page is loaded## Global Head of Total Rewardslocations : Zug : Miami : Boston : Boston : Miamitime type : Full timeposted on : Posted 6 Days Agojob requisition i...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Head of Global Equity Programs

    Head of Global Equity Programs

    KlaviyoBoston, MA, United States
    serp_jobs.job_card.full_time
    Head of Global Equity Programs.Head of Global Equity Programs.This opening requires education at the bachelor level.Head of Global Equity Programs. Klaviyo's global equity compensation programs and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Head of Lead Generation

    Head of Lead Generation

    Financial Recovery TechnologiesMedford, MA, US
    serp_jobs.job_card.full_time
    Financial Recovery Technologies (FRT) is a leading technology-based services firm that helps the investment community identify eligibility, file claims, and recover funds from securities class acti...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Pediatric Integrated Behavioral Health Clinician (LICSW / Psychologist) - Greenbush, MA

    Pediatric Integrated Behavioral Health Clinician (LICSW / Psychologist) - Greenbush, MA

    LifeStance HealthGreenbush, MA, US
    serp_jobs.job_card.full_time +1
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Testing Psychologist (PhD, PsyD)- (Child and Adolescent) - Greenbush, MA

    Clinical Testing Psychologist (PhD, PsyD)- (Child and Adolescent) - Greenbush, MA

    LifeStance HealthGreenbush, MA, US
    serp_jobs.job_card.full_time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Project Manager

    Project Manager

    Cleanroom Constructors IncAttleboro, MA, US
    serp_jobs.job_card.full_time
    The Project Manager is responsible for the overall coordination, planning, procurement, and execution of assigned construction projects. This role ensures projects are delivered on time, within scop...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Psychologist (Child or Adult) - Greenbush, MA

    Clinical Psychologist (Child or Adult) - Greenbush, MA

    LifeStance HealthGreenbush, MA, US
    serp_jobs.job_card.full_time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Head of Engineering & Projects

    Head of Engineering & Projects

    SanofiFramingham, MA, US
    serp_jobs.job_card.full_time
    Head Of Engineering & Projects.With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.We are an innovative globa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Global Head of Active Fixed Income & Multi-Sector Solutions, State Street Investment Management[...]

    Global Head of Active Fixed Income & Multi-Sector Solutions, State Street Investment Management[...]

    State StreetBoston, MA, United States
    serp_jobs.job_card.full_time
    Global Head of Active Fixed Income & Multi-Sector Solutions, State Street Investment Management - Senior Managing Director. At State Street Investment Management, we draw from our global scale and m...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Head of Partnerships

    Head of Partnerships

    vCluster LabsBoston, MA, US
    serp_jobs.job_card.full_time
    We are a venture-backed tech startup striving to be the leading force in enabling platform engineers.We raised +$30M from top-tier VCs such as Khosla Ventures (first investor in OpenAI, GitLab, Str...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Psychologist (Child or Adult) - Cohasset, MA

    Clinical Psychologist (Child or Adult) - Cohasset, MA

    LifeStance HealthCohasset, MA, US
    serp_jobs.job_card.full_time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Global Project Lead

    Global Project Lead

    ChiesiBoston, MA, United States
    serp_jobs.job_card.full_time
    Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi G...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Head of Global Compensation

    Head of Global Compensation

    BitsoCambridge, MA, US
    serp_jobs.job_card.full_time
    Bitso is looking for a Global Head of Compensation to join our team.We're one of the fastest growing and highly trusted crypto exchanges in the LATAM, and this year we are expanding our products be...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Global Head of High Yield and Leveraged Loans, State Street Investment Management - Managing Di[...]

    Global Head of High Yield and Leveraged Loans, State Street Investment Management - Managing Di[...]

    State StreetBoston, MA, United States
    serp_jobs.job_card.full_time
    At State Street Investment Management, we draw from our global scale and market-tested expertise to create original solutions and betteroutcomes for our clients and the world’s investors.The team y...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Licensed Therapist (LCSW, LICSW, LMHC, LMFT)- Child or Adult - Greenbush, MA

    Licensed Therapist (LCSW, LICSW, LMHC, LMFT)- Child or Adult - Greenbush, MA

    LifeStance HealthGreenbush, MA, US
    serp_jobs.job_card.full_time +1
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Head of Product

    Head of Product

    vCluster LabsBoston, MA, US
    serp_jobs.job_card.full_time
    We are a venture-backed tech startup striving to be the leading force in enabling platform engineers.We raised +$30M from top-tier VCs such as Khosla Ventures (first investor in OpenAI, GitLab, Str...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Global Head of L4B Headset Sales

    Global Head of L4B Headset Sales

    LogitechBoston, MA, United States
    serp_jobs.job_card.full_time
    Logitech is the Sweet Spot for people who want their actions to have a positive global impact while having the flexibility to do it in their own way. Global Head of Sales Acceleration, Headsets.Logi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Remote Finance Director - AI Trainer

    Remote Finance Director - AI Trainer

    Data AnnotationPawtucket, Rhode Island
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the q...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30