Executive Director, Early Specialty Medicine Global Clinical Lead

Daiichi Sankyo, Inc.; Basking Ridge (NJ); On-site; USD 329,000 - 548,000; Full time

Job summary

Daiichi Sankyo, Inc. in New Jersey seeks an experienced Global Clinical Lead for non-oncology Specialty Medicine within Early Development Oncology.

The role spans immunology, ophthalmology, cardiovascular disease, and emerging areas, combining broad early-development expertise with end-to-end global development judgment from preclinical through Phase 3. The position replaces a vacant director-level role and requires independent decision-making, global collaboration, and leadership across

Qualifications

• MD is required and postgraduate training in a non-oncology therapeutic area or related specialty is required.
• Global clinical development experience spanning preclinical through Phase 3 with senior-level accountability is expected.
• Experience leading cross-functional study design, execution, and interpretation with a focus on patient safety and data quality.
• Ability to lead external collaborations, engage with regulators, and represent the program in governance forums.

Responsibilities

• Lead end-to-end global clinical development for assigned non-oncology programs from preclinical to Phase 3.
• Provide medical accountability and oversight for clinical trials, including data reviews and safety assessments.
• Direct cross-functional study design, feasibility, execution, and interpretation while ensuring compliance.
• Represent clinical development in regulatory, governance, and external forums; guide due diligence of external opportunities.
• Lead the internal and external clinical network and strengthen development capabilities.

Education

MD

Postgraduate training in non-oncology therapeutic area

Tools

Microsoft Word

Excel

PowerPoint

Electronic Data Capture (e.g., RAVE)

J-Review

Job description

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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). The role 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. This role replaces the vacated Specialty Medicine Director position; it is not incremental headcount. The proposed higher level reflects expanded therapeutic scope, leadership accountability, and independent decision‑making responsibilities.

• Set global clinical development direction across Specialty Medicine, 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.

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 appropriate medical guidance to investigators and review bodies on eligibility, safety, dose modification, and adverse event management, in partnership with relevant functions.
• 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.
• Make independent, risk‑based development choices and represent organizational commitments in portfolio, BD, and governance forums within delegated decision rights; elevate 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.
• 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.

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.
• 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.
• 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 Harmonisation 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

Education

• MD is required
• Postgraduate training in a non‑oncology therapeutic area or related specialty required

Work Experience

• 7+ years of relevant clinical experience, including proven non‑oncology early development in the pharmaceutical or biotechnology industry required.
• Demonstrated innovation and speed across modalities and therapeutic areas required
• 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 required.
• 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.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$329,025.00 - USD$548,375.00

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