Director R&D Sustainability and Medical Governance Operations (Billerica MA)

Merck•Billerica, MA

6d•Onsite

About The Position

The Director, R&D and Medical Governance Operations holds a dual mandate: supporting the Head CMO Governance & Operations in the full spectrum of CMO-GO business operations activities, and serving as the orchestrator and oversight lead for R&D Sustainability initiatives across the R&D organization. The role ensures the smooth execution of governance processes, operational workflows, data systems management, vendor coordination, and training delivery, while simultaneously driving the planning, coordination, and reporting of R&D’s sustainability project portfolio in alignment with the company’s broader ESG and corporate sustainability commitments.

Requirements

Degree in Medicine or Life Sciences required.
Substantial professional experience (typically 8–12 years) in clinical R&D, Medical Affairs, or a comparable function, ideally within an international matrix organization.
Demonstrated experience in business operations, process management, and governance in a pharmaceutical or biotech environment.
Proven track record in orchestrating complex, multi-workstream programmes or project portfolios, including governance design and stakeholder management.
Experience in vendor management, including contracting, performance oversight, and budget tracking.
Familiarity with audit management processes and experience supporting audit preparation and follow-up activities.
Expert knowledge of ICH-GCP and applicable international regulations, laws, and guidelines for clinical studies, Patient Support Programs, and Early Access.
Fluent in English.

Nice To Haves

An advanced scientific degree (Master’s, PhD, or MD) is preferred.
Additional qualification in business administration, project management, or a related discipline is an advantage.
Experience in or strong working knowledge of corporate sustainability / ESG programme management; familiarity with frameworks such as GHG Protocol, CSRD, SBTi, or equivalent is a distinct advantage.
Knowledge of clinical studies, Early Access Programs, Patient Support Programs, and relevant therapeutic areas.
Experience in developing and delivering training programs to diverse internal and affiliate audiences.
Strong programme and project management skills.
Sustainability literacy: understanding of ESG reporting obligations, carbon accounting principles, and the integration of sustainability into R&D operations.
Excellent organizational, prioritization, and time management skills; able to manage multiple concurrent workstreams effectively across two distinct remits.
Strong written and verbal communication skills; able to prepare clear reports, presentations, and governance documents for senior and executive audiences.
Proven ability to build effective working relationships and influence without direct authority in a complex global matrix environment.
High attention to detail and commitment to data quality, documentation standards, and compliance.
Strong digital and database literacy; proficiency with project management tools, data management platforms, and ESG reporting systems.
Additional languages are an advantage.
Willingness to travel domestically and internationally up to 10% as required.

Responsibilities

Supporting the Head CMO Governance & Operations in the full spectrum of CMO-GO business operations activities.
Serving as the orchestrator and oversight lead for R&D Sustainability initiatives across the R&D organization.
Ensuring the smooth execution of governance processes, operational workflows, data systems management, vendor coordination, and training delivery.
Driving the planning, coordination, and reporting of R&D’s sustainability project portfolio in alignment with the company’s broader ESG and corporate sustainability commitments.
Owning and executing the operational backbone of CMO-GO.
Acting as the central orchestrator of R&D Sustainability projects, ensuring cross-functional alignment, milestone delivery, and transparent reporting to R&D and corporate leadership.
Strengthening the organization’s compliance posture through rigorous maintenance of governance documentation, data systems, audit readiness, and training completion.
Embedding sustainability thinking into R&D operations by translating corporate ESG commitments into concrete, measurable R&D-level initiatives and workplans.
Translating external sustainability regulatory landscape requirements (e.g., EU CSRD, GHG reporting) into R&D-specific actions.
Managing competing operational priorities across governance initiatives, sustainability projects, vendor engagements, and stakeholder reporting cycles.
Developing and delivering training programs to diverse internal and affiliate audiences.
Designing governance structures, managing interdependencies, and driving delivery across complex, multi-stakeholder portfolios.
Integrating sustainability into R&D operations.
Preparing clear reports, presentations, and governance documents for senior and executive audiences.
Building effective working relationships and influencing without direct authority in a complex global matrix environment.
Ensuring high attention to detail and commitment to data quality, documentation standards, and compliance.
Utilizing digital and database literacy, including proficiency with project management tools, data management platforms, and ESG reporting systems.