Executive Director, Early Specialty Medicine Global Clinical Lead
Posted Updated
Description
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; 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.
- 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 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
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.