Senior Medical Director, Global Clinical Development Oncology

Merck Group • $217K — $325K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • MD with expertise in clinical drug development
  • Strong expertise in Oncology
  • Minimum 5 years of industry experience in clinical R&D within pharma/biotech
  • Experience leading clinical studies across Phase 1 to Phase III
  • Familiar with regulatory submissions and Health Authority interactions
  • Demonstrated capability in interpreting clinical, translational, and biomarker data
  • Experience leading cross-functional, matrixed, and international teams

Responsibilities

  • Lead clinical development strategy from Phase 1 through Phase III
  • Provide medical leadership on study design and data interpretation
  • Guide indication strategies and overall development pathways
  • Integrate clinical, translational, and biomarker data into decisions
  • Oversee review of safety and efficacy data
  • Drive clinical and regulatory document reviews
  • Represent Clinical Development in Health Authority interactions

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Potential for performance-based bonuses
  • Opportunity for career development in a global organization
Full Job Description
Your Role
As a Senior Medical Director in Global Clinical Development Oncology, you will provide strategic, clinical, and scientific leadership for development programs in oncology. Your focus will be experience with drug development for solid tumors and ideally with experience in targeted therapies and antibody-drug conjugates (ADCs).

Key Accountabilities:
  • Lead and shape clinical development strategy across the development continuum, from Phase 1 through Phase III, including registration-enabling activities, regulatory submissions, dossier contributions, and Health Authority interactions.
  • Provide senior medical leadership on study design, execution, data interpretation, and key development decisions to support the advancement of oncology programs.
  • Guide indication strategy, patient selection, dose optimization, and overall development pathways
  • Integrate clinical, translational, and biomarker data into program decision-making
  • Oversee review and interpretation of safety and efficacy data to support development decisions
  • Drive and review key clinical and regulatory documents, including development plans, protocols, investigator brochures, clinical study reports, briefing books, submission documents, and dossiers
  • Lead or shape registration-enabling activities and regulatory submission strategy
  • Lead or represent Clinical Development in interactions with Health Authorities and internal governance bodies, as appropriate.
  • Serve as a senior leader within cross-functional and global teams, partnering closely with Program Leadership and Management, Translational Medicine, Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology, Safety, and Medical Writing.
  • Influence strategic direction, represent Clinical Development in key forums, and help ensure high-quality and timely delivery of development objectives in an office-based global environment.
  • Partner effectively with cross-functional stakeholders across including Program Leadership and Management, Clinical Operations, Safety, Regulatory Affairs, Biostatistics, Clinical Pharmacology, Translational Medicine, and Medical Writing
  • Provide strategic leadership within global matrix teams to ensure alignment, execution, and delivery against timelines
  • Provide leadership and oversight to team members within Clinical development, as needed
  • Contribute to business process improvement and organizational development initiatives, as appropriate.


Who You Are
Minimum Requirements:
  • MD with expertise in clinical drug development
  • Strong expertise in Oncology
  • Minimum 5 years of industry experience in clinical R&D within pharma/biotech
  • Experience leading or supporting clinical studies across Phase 1 through Phase III
  • Experience contributing to clinical development strategy, registration-enabling activities, and regulatory submissions
  • Familiarity with clinical dossiers, regulatory documentation, and interactions with Health Authorities
  • Demonstrated ability to interpret and apply clinical, translational, and biomarker data to development decisions
  • Experience leading cross-functional, matrixed, and international teams
  • Familiarity with ICH-GCP, FDA and/or EMA expectations, and clinical trial regulations
  • Excellent written and verbal communication skills in English
  • Ability to work effectively in an office-based environment and across global time zones


Preferred Requirements:
  • Experience in targeted therapies, ADCs, immuno-oncology, and/or hematology/hematologic oncology
  • Experience across early and late clinical development
  • Experience with registration strategy and major regulatory submissions
  • Experience engaging with Health Authorities and internal governance forums
  • Experience with precision medicine, and/or biomarker-driven development
  • Experience mentoring, guiding, or managing medical team members
  • Strong strategic thinking, project leadership, and decision-making skills.

Key Competencies
  • Strong clinical and scientific judgment in oncology
  • Strategic thinking and development leadership
  • Ability to translate complex clinical and scientific data into development strategy
  • Effective leadership in cross-functional and global matrix teams; team player mentality
  • Clear and persuasive communication
  • Ownership, accountability, and execution focus
  • Comfort working in a fast-paced, global organization


Location: Billerica, MA, USA; Onsite (Hybrid)

Travel:

Pay range for this position: $217,100.00 - $325,700.00

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
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Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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