Director, Clinical Operations Program Leadership

Jobtailor

Massachusetts

On-site

USD 150,000 - 190,000

Full time

14 days+

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Job summary

Jobtailor is seeking a senior Biotech/Pharma Program Operations leader to drive the development and refinement of study timelines and governance frameworks across clinical programs. This role requires strategic oversight of complex programs and coordination across functional teams in a fast-paced environment.

You will lead cross-functional teams, manage risk, budgets, and vendor relationships (CROs), and translate scientific strategy into executable operational plans while engaging senior

Qualifications

Undergraduate degree in a scientific or health-related discipline.
Advanced scientific or business degree (MS/PhD/PharmD/MBA/MPH) preferred.
Minimum of 12 years’ experience in Biotech/Pharma drug development, clinical research, and operational strategy.
At least 3 years in Biotech/Pharma Program Operational Delivery capacity.
Demonstrated project/program management with risk assessment and mitigations, budget management, and contingency planning.
Proven leadership and ability to influence matrix teams.
Excellent communication, time management and organisational skills.
Experience translating data into executable timelines across multiple therapeutic areas.
Familiarity with Clinical Development Plans (CDPs) and governance frameworks.

Responsibilities

Leads the development and refinement of study timelines and governance in clinical programs.
Provide objective information and aligned recommendations to support strategic decisions.
Accountable for QSDO delivery of clinical studies within a program and governance aligned timelines and recruitment goals.
Learn and adapt to organizational governance processes.
Lead COPL input and governance presentations integrating operational voice.
Engage with senior leaders to communicate risks and messages.
Align governance materials with Head of QSDO and Head of CTDU on timelines.
Coordinate with Biogen and CROs/vendors to support program execution.
Escalate CRO/FSP issues and drive risk mitigation to meet timelines.
Develop and execute a QSDO Program Operational Plan (POP) for the molecule and future development.

Skills

Program operational delivery

Project management

CDPs

Risk assessment

Communication

Team leadership

Influencing skills

Problem solving

Time management

Education

Undergraduate degree in scientific discipline

Advanced degree (MS/PhD/PharmD/MBA/MPH)

Job description

Leads the development and ongoing refinement of program level study timelines and scenarios in order to contribute to the Integrated Asset Plan (IAP) and other high-level strategic plans

Provide rigorous, objective information (status and updates) and aligned QSDO recommendations to DAT to support strategic project decisions

Takes overall accountability for QSDO delivery of the clinical studies within a program and provides appropriate oversight to ensure a high quality, ethical, cost-efficient way to meet governance approved timelines and patient recruitment goals

Ability to learn and adapt to the organizational governance framework and associated processes

Accountable to lead the COPL input and development of governance presentations and/or memos including integration of the operational voice

Ability to engage/communicate key messages, including risks, to senior and executive level functional leaders outside of QSDO

Ability to reach technical alignment on governance materials with the Head of QSDO and Head of CTDU in accordance with associated governance timelines

Engage proactively with Biogen and partner stakeholders (e.g. CROs, vendors) and appropriately leverage QSDO governance to support clinical program execution

Responsible for escalating CRO/FSP, vendor delivery issues to senior leadership at vendor partner level, driving delivery of risk mitigation strategies to maintain and deliver program timelines

Responsible for the development and execution of a QSDO Program Operational Plan (POP) accounting for the therapeutic area and underlying science and opportunities for innovation and operational consistency as well as the future clinical, regulatory, and commercial development plan for the molecule

Proactively integrates stage-appropriate needs into operational strategy

Cascades the POP within QSDO to appropriate sub functions to establish vision and strategic framework for successfully delivery at the study level and with individual areas of technical expertise

May participate as a functional contributor to due diligence/business evaluations including the review of external CDP and strategy, the development of internal timelines, scenarios and recommendations, the review of external capabilities and the development of QSDO resource plans for potential new clinical candidates

Requirements

Undergraduate degree in a scientific or health-related discipline
Advanced scientific or business degree or equivalent experience (MS/PhD/PharmD/MBA/MPH) preferred
Minimum of 12 years’ experience within a Biotech/Pharma environment in drug development, clinical research, and operational strategy experience, ensuring studies and programs are executed to quality, timelines, and budget
At least 3 years of this time in a Biotech/Pharma Program Operational Delivery capacity is required
Demonstration of project/program management skills including risk assessment and identification of mitigations, timeline and budget management, and contingency planning
Demonstration of effective team leadership and an ability to effectively influence matrix teams
Excellent communication, time management, and organizational skills, along with problem solving, conflict resolution, and team building skills
Experience identifying and leveraging relevant data and information to develop well-conceived and executable timelines
Experience across several complex therapeutic areas
Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery
Deep operational expertise
Experience planning and delivering global clinical programs and studies through all stages of development Ph 1-4 and LCM
Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired.

Core Competencies

Demonstrates extensive experience in drug development and clinical research within the Biotech/Pharma industry, with a strong focus on program operational delivery, project management, and strategic planning. Proven ability to lead cross-functional teams, communicate effectively with senior leadership, and develop executable timelines for clinical studies.

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