Senior Manager, Master Production Planning - Clinical Supply

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

KEY RESPONSIBILITIES:

The Senior Manager, Master Production Planning – Clinical Supply oversees strategy and execution for clinical master production planning across multiple programs or sites. The role ensures an agile, compliant supply of investigational medicinal products to support global trials in unpredictable conditions.

Responsibilities include planning leadership, risk governance, and decision support across functions, balancing trial needs with capacity, inventory, and timelines. The position also manages clinical master data creation and maintenance.

The role may have people leadership accountabilities which include recruiting, onboarding, developing, retaining and managing staff.

The role may have accountability for the strategy, implementation and management of digital tools and systems that support Global Clinical Supply Chain. The intent is to bridge gap between supply chain processes and information technology, ensuring the right digital or technology platform is in place to optimize clinical supply planning, inventory management and distribution.

Has mature working knowledge of supply chain and experience working with GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills in a fast-paced, global company.

FOCUS AREAS:

Strategic Clinical Production Planning Leadership

• Own clinical master production planning strategy for a portfolio of clinical programs (Phase I–III), dosage forms, or platforms.

• Ensure alignment between clinical development plans, enrollment trajectories, and manufacturing capabilities.

• Define planning assumptions, buffers, and risk thresholds appropriate for differing trial phases and uncertainty profiles.

• Provide leadership on make‑vs‑make‑later, campaign sizing, and inventory positioning decisions for IMP supply.

Portfolio ‑ Level MPS Ownership

• Oversee and approve clinical Master Production Schedules (MPS) with a portfolio view across sites, CMOs, and packaging hubs.

• Ensure feasibility across capacity, materials, quality release, stability, expiry, labeling, and cold‑chain constraints.

• Drive schedule stability while enabling rapid response to protocol amendments, enrollment changes, or clinical strategy shifts.

Governance, Risk & Decision Support

• Serve as a key planning representative in clinical supply governance and escalation forums.

• Lead proactive identification of supply and capacity risks, including mitigation and contingency planning.

• Provide scenario‑based recommendations to senior stakeholders on supply trade‑offs, clinical impacts, and cost implications.

• Sponsor or approve supply recovery strategies for deviations, quality events, or unplanned manufacturing disruptions.

GMP, GxP & Inspection Readiness

• Ensure all planning activities comply with GMP/GxP, GCP, and internal quality systems governing IMP supply.

• Provide oversight for planning‑related change controls, deviations, and regulatory impact assessments.

• Ensure planning processes, assumptions, and decisions are inspection‑ready and auditable.

Cross ‑ Functional & External Leadership

• Partner with Clinical Operations, Development, Quality, MS&T, Regulatory, Procurement, and External Manufacturing leadership.

• Align internal and external manufacturing strategies to evolving clinical demand and portfolio priorities.

• Influence without authority across matrixed organizations to drive timely and balanced supply decisions.

Systems, Analytics & Continuous Improvement

• Sponsor enhancements to planning systems, data visibility, and scenario modeling for clinical supply.

• Drive continuous improvement initiatives focused on responsiveness, inventory stewardship, and waste reduction.

• Support digital transformation initiatives across Clinical Supply Chain and Technical Operations.

Key Performance Indicators (Typical)

• Clinical trial supply continuity (no‑fault interruptions)

• Risk‑adjusted inventory and expiry performance

• Planning responsiveness to protocol and enrollment changes

• Schedule feasibility and execution stability

• Audit and inspection outcomes

Basic Qualifications

• Bachelor's Degree and 8 years’ experience

OR

• Master's Degree and 6 years’ experience

OR

• PhD /PharmD and 2 years’ experience

Preferred Qualifications:

• Experience in production planning / supply planning, with significant experience in clinical supply or regulated pharmaceutical manufacturing.

• Degrees in Supply Chain, Engineering, Life Sciences or related field is preferred.

• Strong working knowledge in clinical supply management including and not limited to forecasting, demand / supply planning, IVRS and ERP systems.

• Strong working knowledge of clinical study designs, blinding practices, global trials, from Phase 1 first in human to late phase.

• Strong working knowledge of Clinical Demand and Operations Planning (CD&OP).

• Demonstrated leadership of complex, high‑uncertainty supply portfolios

• Strong understanding of IMP manufacturing, packaging, labeling, and release processes

• Proven ability to lead cross‑functional decision‑making in matrixed organizations

• Ability to collaborate, influence and negotiate to work effectively with cross-functional teams and external suppliers to meet clinical development timelines and patient needs.

• Works effectively with ambiguity. Ability to devise, assess and implement best options in alignment with Gilead's core values and functional expectations.

• Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents/presentations.

• Strategic, enterprise thinking with ability to distill complex business problems to technology solutions.

• Strong or excellent computer skills (e.g., email, word processing, spreadsheet creation and management, online search, etc.). Ability to efficiently adopt systems and databases used at Gilead.

• Ability to manage the cross functional resources and timelines for complex clinical study and programs or initiatives/projects. Project management experience preferred.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.