Global Clinical Head-Cell Therapy jobs in United States
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AstraZeneca · 14 hours ago

Global Clinical Head-Cell Therapy

AstraZeneca is dedicated to transforming the lives of patients living with cancer through innovative therapies. The Global Clinical Head will define and develop clinical development plans for cell therapy products, ensuring scientific value creation and leading a team of Global Development Medical Directors.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Delivery of the product Target Product Profile (TPP) and Target Product Claims (TPC) and maintenance of the Integrated Product Development Plan (iPDP)
Manage and develop a team of Global Development Medical Directors within a Global Product Team (GPT). Ensure delivery as a core member of the GPT team by providing overall clinical leadership of the asset
Full responsibility for the planning, implementation and operation of the product's drug development projects, including responsibility to:
Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment
Design scientifically meticulous and cost-effective clinical protocols that are aligned with the clinical development plan
Present and defend protocols and clinical development plans at internal governance forums
Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team
Present study updates, interim results, and final headline data to senior management as required
Lead preparation of documents for Regulatory and other agencies, such as Dossiers, NDA, BLAs, INDs, Safety and Annual reports
Identify and assess clinical opportunities for the asset
Work with functional management to develop plans and resolve issues
Deliver product information to support internal and external business portfolio reporting (eg. CEO briefings, annual results communications etc)
Develop all external information on the product (including publications, regulatory documents, clinical trial registers etc)
Manage and protect the Intellectual Property (IP) assets of the product in consultation with IP and legal specialists including leadership of the Patent, Regulatory and Legal Defense Team

Qualification

Oncology expertiseClinical drug developmentCell therapy expertiseRegulatory document preparationClinical leadershipCommunication skillsStrategic thinkingTeam management

Required

Qualified Physician (M.D. degree or international equivalent)
Oncology clinical drug development experience in academic institution or biopharma industry (Minimum 7 years of experience)
Cell therapy expertise
Deep oncology expertise. Fully conversant with science as it relates to the brand
Understands unmet market needs, creates a clear path forward, shows how to win
Robust knowledge of and evidence of successful oncology product development based on strong science, commercial insights, market research and competitive intelligence
Demonstrated understanding of oncology patient selection and stratification including companion/complementary diagnostic development and registration
Ability to provide clinical leadership for an asset to multiple stakeholders through clear communication and strategic thinking

Preferred

MD, PHD
Industry experience preferred
Medical specialty and sub-specialty training and certification in Oncology or Hematology preferred
Clinical experience in treating and managing Cancer patients preferred
Credible with Key External Oncology Stakeholders, Payers and oncology scientific communities

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

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AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (11)

Funding

Current Stage
Public Company
Total Funding
$5.26B
2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B

Leadership Team

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Pascal Soriot
Chief Executive Officer
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Aradhana Sarin
Group CFO and Executive Director
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Company data provided by crunchbase