Head of Oral Drug Products (Vice President)

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Job Description

OBJECTIVES/PURPOSE:

• Leads the global Oral Drug Product organization and delivery of oral drug product development from early phase through commercialization and lifecycle management.

• Sets strategy and builds capabilities for robust, scalable oral formulations and manufacturing processes, including tech transfer and process validation/PPQ readiness.

• Partners with PharmSci functions and key stakeholders (GSQ, Quality, Regulatory CMC, Commercial, R&D, Supply Chain) and external partners to deliver high-quality oral products.

ACCOUNTABILITIES: 

• Owns the global Oral Drug Product strategy and operating model to deliver phase-appropriate, scalable, and robust oral dosage forms across the pipeline and lifecycle.

• Accountable for oral drug product design and development from pre-formulation through clinical and commercial readiness, including selection of dosage form, excipients, and process pathway consistent with target product profile.

• Leads development of robust oral formulations and control strategies using QbD principles, including identification of CQAs, CPPs, design space (where appropriate), and lifecycle management plans.

• Oversees oral process development and scale-up (e.g., blending, granulation, compression, coating, encapsulation, hot-melt extrusion, spray drying, 3D/continuous manufacturing where applicable), including tech transfer to internal sites and/or CMOs through PPQ and commercialization.

• Accountable for CMC deliverables for global submissions (IND/CTA/NDA/MAA variations), ensuring high-quality module content, responses, and inspection readiness for oral drug products.

• Establishes platform approaches and standards for oral dosage forms (e.g., enabling formulations, pediatric/geriatric considerations, modified release strategies) to increase reuse and reduce cycle time.

• Drives science- and data-based selection and management of CMOs/CDMOs for oral products, including governance, performance, supply risk mitigation, and technical oversight.

• Partners effectively with Analytical, Drug Substance, Device (as needed), Regulatory CMC, Quality/GSQ, Supply Chain, and Commercial to assure robust product and process strategies through launch and beyond.

• Builds a high-performing global organization; develops talent, ensures appropriate resourcing across programs, and drives a culture of innovation, compliance, and continuous improvement.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Deep expertise in oral solid dose and oral enabling technologies (BCS-driven strategy, solubility/permeability enhancement, amorphous dispersions, salt/co-crystal selection interface, lipid-based formulations where appropriate).

• Strong experience in oral pre-formulation and biopharmaceutics-facing formulation design (dissolution, supersaturation, precipitation risk, food effect considerations, IVIVC/biorelevant methods alignment).

• Demonstrated capability in oral process development, scale-up, and manufacturing science (unit operations, PAT, continuous manufacturing understanding, process robustness, control strategy).

• Experience with global GMP and oral product regulatory expectations, including CMC submission strategy, lifecycle management, and inspection readiness.

• Proven leadership in tech transfer to internal sites and CMOs, including process validation/PPQ execution and commercial troubleshooting.

• Knowledge of packaging/CCS considerations for oral products (e.g., blister vs bottle, moisture/oxygen/light protection, stability strategy alignment).

Leadership

• Strategic thinking, facilitative leadership.

• Executive leadership presence and confidence.

• Enterprise level leadership with the ability to inspire, motivate and drive results.

• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.

• Ability to assemble and manage a diverse and high performing team.

• Demonstrated ability to lead teams across functions, regions and cultures.