Head of Emerging Indications, Oncology Clinical Development
Location
United States
Posted
1 day ago
Salary
$228.1K - $325.9K / year
Seniority
Lead
No structured requirement data.
Job Description
Head of Emerging Indications, Oncology Clinical Development
Astellas Pharma
Role Description 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. Responsibilities and Accountabilities - 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. - 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. - 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. - 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. - 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. Qualifications - Advanced degree in life sciences, medicine, or related field. - 8–10+ years of experience in 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. 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 - Medical, Dental and Vision Insurance. - Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down. - 401(k) match and annual company contribution. - Company paid life insurance. - Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions. - Long Term Incentive Plan for eligible positions. - Company fleet vehicle for eligible positions. - Referral bonus program.
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Senior Biostatistician – Contract
Vividion Therapeutics. Inc.Precision Science Inspired by Human Biology
• Provide support to clinical trials or other scientific research studies. • Assist with development of statistical analysis plans, Mock TFL shells (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation) with details for programming implementation. • Under supervision, help to oversee and QC CRO’s work. • Collaborate with Statistical Programming and work on QCing of internal programming outputs to ensure the delivery of high-quality outputs according to agreed-upon timelines. • Assist in identifying scientifically appropriate data collection instruments. • Identify and report data issues or violations of study assumptions. • Provide programming specifications for derived variables and analysis datasets. • Collaborate with Data Management in preparing for database lock. • With supervision perform statistical analyses as per the analysis plan. • Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. • Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality. • Work collaboratively with cross-functional teams, such as DM, medical team, PK/PD teams.
• Design and analyze clinical trials, interpreting complex medical data • Lead on biostatistics tasks requiring technical depth, focusing on quality and continuous improvement • Serve as lead biostatistician for simple to complex clinical studies • Develop statistical analysis plans and reporting specifications • Responsible for statistical aspects of CRF design and edit specifications • Perform statistical analyses and interpret results for clinical studies • Review randomization specifications and dummy randomization schemes • Participate in bid defense meetings
• Provides scientific and/or medical expertise for clinical research aspects of the project • Participates in strategic meetings/advisory boards as key clinical research representative • Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc.) • Consults with internal/external stakeholders and internal/external key opinion leaders • Provides support to other functional members of the project team • Interacts with investigators and CROs as the medical or scientific representative • Provides medical and scientific interpretation of efficacy and safety data • Participates in the interactions with regulatory authorities (e.g., FDA, EMEA meetings) • Provides input for a project publication plan, liaises with commercial and works on launch activities when required • Creates and reviews abstracts, and manuscripts created by internal or external sources
Role Description - Organisation, Koordination und Monitoring klinischer Studien gemäß ICH- und GCP-Richtlinien sowie interner SOPs - Rekrutierung, Selektion und Training von Prüfärzten und Studienzentren - Durchführung der Studieninitiierung, des Routine-Monitorings (on-site / remote) und des Abschlussbesuchs an deutschlandweiten Prüfzentren einschließlich Zentrumskommunikation und schriftlicher Dokumentation - Identifizierung von Problemen vor Ort und Eskalation an den Studiensponsor - Konzeptionierung und Einreichung der Unterlagen bei Ethikkommissionen und Bundesoberbehörden sowie Unterstützung bei der Korrespondenz - Termin- und Fristenüberwachung - Pflege von Studiendaten in Datenbanken (Access, Excel) - Unterstützung bei Einreichungstätigkeiten / Führen des TMF Qualifications - mind. 1 Jahr Erfahrung als klinischer Monitor - Sehr gute ICH-GCP- und AMG-Kenntnisse - Sehr gute PC-Anwenderkenntnisse (MS-Office) - Gute Englischkenntnisse in Wort und Schrift - Sehr gute Organisationsfähigkeit, Selbständigkeit, Flexibilität, Zuverlässigkeit - ausgeprägter Teamgeist, Kommunikationsfähigkeit und Aufgeschlossenheit - Idealer Weise Kenntnisse im Bereich Monitoring onkologischer Studien Benefits - Wir bieten Ihnen eine abwechslungsreiche und interessante Tätigkeit in einem wachsenden Unternehmen sowie einen sicheren Arbeitsplatz.


