Astellas Pharma US, Inc

Medical Development Head of Emerging Indications, Executive Director

Astellas Pharma US, Inc • $210K — $250K *
Cambridge, MA 02139In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 7+ years in pharmaceutical or biotechnology sector with a focus on oncology clinical development
  • Strong strategic planning capability to create actionable plans
  • Experience in global team leadership and managing complex clinical programs
  • Proficient in clinical development strategies and regulatory submissions
  • Cross-functional expertise in clinical, regulatory, safety, and commercial realms
  • Experience in business development assessments and due diligence
  • Demonstrated success in people management and talent development

Responsibilities

  • Define and lead emerging oncology disease cluster strategies for portfolio growth
  • Oversee execution of clinical programs ensuring scientific rigor and regulatory alignment
  • Drive integrated strategies across various departments for seamless collaboration
  • Evaluate and lead business development and partnership opportunities
  • Contribute to governance forums providing strong medical insights for compliance and operational excellence

Benefits

  • Hybrid work flexibility including 1 day onsite per quarter in London
  • Recognition of work/life balance with a supportive work environment
  • Opportunity to connect with colleagues in a dynamic office setting
  • Focused on optimizing productivity for all employees
  • Permanent full-time role in a leading biopharmaceutical company
Full Job Description
Working Environment and Location

  • This position is hybrid and will require you to be onsite 1 day per quarter at Bourne office in London, UK. The role is offered on a hybrid basis
  • At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.


Purpose and Scope

  • The Head of Emerging Indications is a senior leader in Oncology Medical Development, reporting to the Head of Oncology Medical Development. This "above-asset" position is accountable for shaping and executing clinical development strategy across emerging disease areas, with a strong focus on enabling enterprise growth through entry into new indications.
  • The role provides leadership and oversight to multiple Global Medical Leads and drives delivery excellence across a portfolio of early- and late-stage programs. This leader plays a critical role in defining future portfolio direction through disease cluster strategy and active participation in business development activities.
  • This is a permanent full-time position.


Role and Responsibilities

  • Portfolio Leadership and Emerging Indications Strategy
  • Clinical Development Leadership and Execution Excellence
  • Cross-Functional, End-to-End Leadership and Integration
  • Business Development and External Engagement
  • Governance, Compliance, and Operational Excellence


1. Portfolio Leadership and Emerging Indications Strategy
    • Define and lead disease cluster strategies to enable entry into new and emerging oncology indications, aligned with enterprise priorities
    • Identify and shape opportunity spaces, integrating internal and external insights
    • Serve as a key thought partner in portfolio prioritization and long-term disease cluster strategy
    • Drive strategic decisions to ensure sustainable portfolio growth and differentiation

2. Clinical Development Leadership and Execution Excellence
    • Provide oversight and direction to Global Medical Leads to ensure high-quality, timely execution of clinical programs
    • Guide design, review, and governance of clinical study protocols, ensuring scientific rigor, feasibility, and regulatory alignment
    • Ensure delivery of high-quality, credible data to support regulatory submissions, publications, and lifecycle strategies
    • Embed a culture of accountability, urgency, and excellence in execution across programs
    • Ensure optimal resource planning and deployment across the Emerging Indications portfolio


Continue:Role and Responsibilities

3. Cross-Functional, End-to-End Leadership and Integration
    • Ensure integrated, end-to-end development strategies that align with regulatory and commercial objectives through seamless collaboration across Research, Early Development, Clinical Operations, Regulatory, Quantitative Sciences, Safety, Medical Affairs, and Commercial

4. Business Development and External Engagement
    • Play a key leadership role in evaluation of in-licensing, out-licensing, and partnership opportunities
    • Provide Medical Development expertise in due diligence, asset valuation, and integration planning
    • Contribute to strategy development for multi-track business development initiatives within Oncology

5. Governance, Compliance, and Operational Excellence
    • Participate/Lead governance forums, providing a strong Medical Development perspective
    • Ensure adherence to ICH, GCP, and Astellas policies across all development activities
    • Contribute to the establishment and continuous improvement of processes and SOPs


Essential Qualifications

  • Extensive experience working within the pharmaceutical / biotechnology industry, including significant oncology clinical development experience across phases
  • Strategic thinker with the ability to translate vision into actionable plans with accountability and urgency that integrates diverse perspectives
  • Demonstrated experience leading global development teams and complex programs
  • Proven ability to develop and execute clinical development strategies and regulatory submissions
  • Strong cross-functional expertise spanning clinical, regulatory, safety, and commercial considerations
  • Experience contributing to or leading business development assessments and due diligence
  • Established track record in people leadership, talent development, and change management
  • Exceptional communication skills with the ability to convey complex concepts clearly to the common denominator and influence across diverse stakeholders with keen cultural awareness
  • Advanced degree in life sciences, medicine, or related field


Preferred Qualifications

  • MD degree with board certification and clinical oncology practice experience
  • Experience in thoracic oncology
  • Exposure in related and complimentary functional areas (medical affairs, safety science, etc)
  • Experience managing multi-year budgets and resource allocation across complex portfolios


Benefits

About Astellas Pharma US, Inc

Astellas Pharma US, Inc is a pharmaceutical company that develops and markets drugs for the treatment of cancer, immunology, and urology. The company is a subsidiary of Astellas Pharma Inc, a Japanese pharmaceutical company. Astellas Pharma US, Inc was founded in 2005 and is headquartered in Northbrook, Illinois. The company has over 17,000 employees and operates in over 50 countries. Astellas Pharma US, Inc is committed to improving the health and well-being of patients through the development of innovative and effective therapies.
Learn more about Astellas Pharma US, Inc
Size
14,522 employees
Industry
Pharmaceuticals & Biotech
Founded
2005
NASDAQ
ALPMF
* Ladders Estimates

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