Job Summary

The Early Specialty Medicine Global Clinical Lead provides senior medical, scientific, and strategic leadership for the non-oncology Specialty Medicine portfolio within Early Development Oncology (EDO), with clinical development oversight across all Specialty Medicine programs. The role helps influence the strategic direction of the Specialty Medicine portfolio and spans immunology, the newly established ophthalmology program, cardiovascular disease, and other emerging therapeutic areas, combining broad early-development expertise with end-to-end global development judgment from preclinical development through Phase 3. When needed, the role may be called upon to provide input on late-stage development and regulatory strategy.

Position Summary

• Oversee clinical development across the full Specialty Medicine portfolio and help shape its global strategic direction, sustaining ongoing immunology programs while advancing ophthalmology, cardiovascular, and emerging assets.
• Lead cross-functional internal and external teams using EDO ways of working: move quickly, take prudent risks, and drive timely decisions through close partnership.
• Own risk-based clinical development decisions within delegated authority and governance requirements, providing continuity from pre-DP0 through pre-DP2 and beyond and overseeing Phase 1–Phase 3 studies as assigned.
• Represent clinical development in portfolio, business development (BD), governance, partner, and regulatory forums; assess new assets and build capabilities as the Specialty Medicine portfolio evolves.
• Provide clinical input on late-stage development and regulatory strategy when called upon, supporting continuity across the end-to-end development lifecycle.

Job Description

Responsibilities

Global Clinical Program Leadership & Medical Accountability

• Lead end-to-end global clinical development for assigned non-oncology programs, translating preclinical findings into actionable clinical plans and accelerating generation of decision-enabling data.
• Direct cross-functional study design, feasibility, execution, and interpretation; resolve development trade-offs promptly while maintaining patient safety, scientific rigor, data quality, and compliance.
• Provide medical accountability and oversight for clinical trials, including ongoing clinical data review, protocol deviations, benefit–risk assessment, and timely medical decisions.
• Ensure continuous reassessment of benefit–risk profiles across Specialty Medicine programs, safeguarding study conduct and patient safety at the portfolio level.
• Ensure appropriate medical guidance to investigators and review bodies on eligibility, safety, dose modification, and adverse event management, in partnership with relevant functions.
• Set clear objectives, coach, and mentor clinical team members; build the talent and capabilities needed to deliver the Specialty Medicine development strategy globally.
• Lead the internal and external clinical network, oversee CRO medical monitoring, and strengthen Specialty Medicine development capabilities and program continuity.

Portfolio Strategy, Governance & Business Development

• Own integrated Clinical Development Plans aligned with Target Product Profiles, portfolio priorities, and decision milestones from pre-DP0 through pre-DP2 and beyond.
• Set clinical strategy across immunology, ophthalmology, cardiovascular disease, and emerging therapeutic areas; apply broad non-oncology expertise across modalities and adapt plans as the portfolio evolves. Provide clinical development oversight for the entire Specialty Medicine portfolio and help influence its strategic direction in partnership with Specialty Medicine and EDO leadership.
• Make independent, risk-based development choices and represent organizational commitments in portfolio, BD, and governance forums within delegated decision rights; escalate matters outside that authority.
• Lead clinical assessment and due diligence of external opportunities, evaluating scientific rationale, development feasibility, risks, and portfolio fit; guide integration of acquired or partnered assets.
• Apply disease-landscape, competitive, and product-positioning insights to prioritize clinical opportunities and propose innovative, efficient development approaches. Help maximize portfolio value through effective management of quality, cost, time, and risk, and contribute clinical perspective to portfolio prioritization and resourcing.
• Lead development recommendations and data presentations to governance bodies; establish clear decision criteria and maintain appropriate DMC and Steering Committee oversight.
• Build effective partnerships across clinical, preclinical, regulatory, safety, and operational functions and external organizations to sustain speed, continuity, and readiness for later-stage development. Integrate input from global functions (e.g., Regulatory Affairs, Clinical Operations, Biostatistics, Precision Medicine, Asset & Portfolio Management, Safety, HEOR) into the overall Specialty Medicine clinical development strategy.

Responsibilities Continued

Health Authority Interactions & Publications

• Lead the clinical and medical contribution to global Health Authority interactions, including FDA, MHRA, EMA, and PMDA meetings, submissions, development milestones, and inspections, in partnership with Regulatory Affairs. When called upon, provide clinical and regulatory input to late-stage development, registration, and lifecycle management strategies, drawing on end-to-end development experience.
• Own the clinical publication and communication strategy for assigned programs and provide medical leadership for protocols, clinical study reports, investigator brochures, regulatory responses, and safety reports.
• Represent Specialty Medicine credibly with regulators, external experts, advisory boards, partners, and BD counterparties; communicate evidence, uncertainties, and development decisions clearly.

Competencies

• Strategic and critical thinking, with portfolio-level judgment and independent, risk-based decision-making under uncertainty.
• Excellent verbal, written, communication, and interpersonal skills
• Executive-level communication and credible representation in portfolio, governance, BD, regulatory, and scientific forums.
• Enterprise mindset: knows the business and competitive landscape, creates long-term patient value through strategic thinking, and builds support for ideas with key internal and external stakeholders.
• Broad non-oncology development expertise and adaptability across immunology, ophthalmology, cardiovascular disease, and emerging therapeutic areas; relevant subspecialty training desired.
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• End-to-end global drug development expertise, from preclinical translation and early clinical decisions through Phase 3, with continuity across development milestones.
• Expertise in the components needed to execute an effective clinical plan and protocols
• Commitment to Data Quality
• Solid knowledge of compliance and global regulatory requirements [International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice Guidelines (ICH GCP)] for drug development
• Cross-functional leadership, consensus building, and capability development in a fast-paced, hands-on environment; ability to move quickly, take prudent risks, and maintain clear accountability.
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review, or similar data reporting tools

Qualifications

Work Experience

• 10 or more years relevant experience is required.
• Relevant clinical experience, including strong, proven non-oncology early development experience across a variety of therapeutic areas in the pharmaceutical or biotechnology industry is required.
• Demonstrated innovation and speed across modalities and therapeutic areas; a track record of shaping clinical development and portfolio strategy and influencing senior leadership decisions; global development experience spanning preclinical development through Phase 3; and senior-level accountability for independent development decisions, portfolio judgment, BD due diligence, governance representation, and external engagement is required.
• Experience leading global, cross-functional development teams and influencing internal and external stakeholders, including regulatory authorities is required.
• End-to-end development experience, including late-stage development, registration, and regulatory interactions, is beneficial.
• An experienced senior-level candidate with broad generalist expertise is preferred.

Travel Requirements
Ability to travel up to 20% of the time. Domestic and International travel will be required.