Senior Director, Oncology Clinical Development & Strategy

MSD Malaysia; Rahway (NJ); Hybrid; USD 311,000 - 489,000; Full time

Job summary

The Executive Director (Distinguished Scientist) and Product Development Team lead at Merck Rahway, NJ, will plan and direct late-stage clinical development for oncology medicines, from Phase 2 to Phase 5, including strategy, design, and regulatory considerations.

You will manage and lead cross-functional teams, interact with regulatory authorities, and communicate progress to senior management, ensuring alignment with corporate objectives and robust scientific leadership.

Qualifications

• Minimum of 3 years of clinical medicine experience.
• Minimum of 5 years of industry experience in drug development with demonstrated success in overseeing multiple studies and protocols through completion.
• Experience in authoring regulatory documents and leading discussions with regulatory agencies.
• Demonstrated record of scientific scholarship and achievement.
• Proven track record in clinical medicine and background in biomedical research.
• Outstanding interpersonal and collaborative skills, as well as the ability to function in a matrix environment.
• Excellence in delivering clear, impactful communication verbally, in writing, and during presentations.

Responsibilities

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications.
• Developing clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.
• Executing the clinical strategy, planning clinical trials (design, operational plans, settings), and leading the clinical subteam.
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed medicines.
• Leading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines.
• Acting as an integration of cross-functional input and expertise, ensuring all perspectives are incorporated into the strategy/plan and serve as the product development team spokesperson.
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications.
• Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
• Supporting business development assessments of external opportunities.
• Managing Clinical Directors and/or Senior Clinical Directors responsible for [insert therapeutic area] clinical development work, demonstrating effective leadership and fostering a high-performance culture.
• Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assist the AVP/VP in informing corporate personnel of study progress and external expert opinions.
• Leading internal governance presentations to senior management and committees, communicating progress and changes in product development strategy between stage gates, and facilitating cross-functional collaboration for governance approval.

Skills

Clinical Development

Clinical Judgment

Clinical Medicine

Clinical Trial Development

Ethical Standards

Hematology

Intellectual Curiosity

Interdisciplinary Problem Solving

Lymphoma

Mentorship

Program Strategy

Regulatory Compliance

Scientific Leadership

Senior Program Management

Strategic Planning

Education

MD or MD/PhD

Job description

The Executive Director (Distinguished Scientist) and Product Development Team lead at Merck Rahway, NJ, will plan and direct late-stage clinical development for oncology medicines, from Phase 2 to Phase 5, including strategy, design, and regulatory considerations.

You will manage and lead cross-functional teams, interact with regulatory authorities, and communicate progress to senior management, ensuring alignment with corporate objectives and robust scientific leadership.