Senior Medical Director, Clinical Development (Remote)

SoTalent; United States; Remote; USD 308,000 - 462,000; Full time

Job summary

Sotalent is seeking a Senior Medical Director, Clinical Development – Solid Tumor Oncology to provide senior medical leadership across solid tumor programs from early development through registration and post-approval.

You will shape clinical strategy, guide trial design, endpoints, biomarker strategy, and safety governance, collaborating with Regulatory Affairs, Biostatistics, Clinical Operations and Medical Affairs.

Qualifications

• MD or MD/PhD required; board certification in Oncology.
• 10+ years of clinical/pharma industry experience in oncology.
• Global clinical development and late-phase experience.
• Strong leadership in a matrixed organisation with medical judgment.

Responsibilities

• Provide strategic medical oversight for solid tumor programs from development through registration and post-approval.
• Lead integrated clinical development plans and cross-functional collaboration.
• Engage with regulators and external experts; contribute to submissions and regulatory materials.
• Mentor medical directors and physicians; drive scientific excellence and patient-centered decisions.

Skills

Leadership

Strategic thinking

Communication

Stakeholder management

Education

MD or MD/PhD

Board certification in Oncology

Job description

Senior Medical Director, Clinical Development – Solid Tumor Oncology

Location: United States – Remote

Industry: Biopharmaceutical / Life Sciences

Employment Type: Full-time

Role Overview

A global biopharmaceutical organisation is seeking a Senior Medical Director, Clinical Development – Solid Tumor Oncology to provide senior medical and clinical leadership across solid tumor development programs.

The role will shape and execute clinical and medical strategies throughout the drug development lifecycle, from early development through registration and post-approval activities. The successful candidate will provide scientific leadership, guide evidence generation and clinical trial strategy, and support high-quality, patient-focused decision-making across a complex oncology portfolio.

This position will work closely with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, Medical Affairs, and other cross-functional teams, while representing the organisation with regulators, investigators, key opinion leaders, and external scientific experts.

Key Responsibilities

Clinical & Medical Leadership

• Provide strategic medical oversight for solid tumor oncology programs from early development through registration and post-approval.
• Serve as the medical authority for assigned development assets, ensuring scientific integrity, patient safety, and regulatory compliance.
• Guide clinical trial design, endpoint selection, biomarker strategy, and integration of translational science.
• Oversee medical monitoring and contribute to safety governance committees, including Safety Monitoring Committees and Data Monitoring Committees where appropriate.

Clinical Development Strategy

• Lead the development and execution of integrated clinical development plans based on unmet medical needs, scientific evidence, and the competitive landscape.
• Partner with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, and Translational Medicine teams to deliver high-quality clinical programs.
• Contribute to portfolio strategy, asset prioritisation, development decisions, and lifecycle management.
• Support strategic decisions across complex and evolving oncology development programs.

Regulatory & External Engagement

• Serve as a key medical contributor in interactions with global regulatory authorities, including the FDA and EMA.
• Support the preparation and review of regulatory documentation, including protocols, Clinical Study Reports, Investigator's Brochures, IND/CTA submissions, and regulatory briefing materials.
• Establish and maintain relationships with clinical investigators, academic collaborators, key opinion leaders, and external scientific experts.
• Represent the organisation as a credible medical and scientific leader in external engagements.

Medical Affairs & Scientific Communication

• Partner with Medical Affairs to support the transition from clinical development through launch and post-marketing activities.
• Contribute to publication strategy, abstracts, congress presentations, and scientific communications.
• Support scientific exchange and communication of clinical development strategy and findings to internal and external audiences.

Leadership & Talent Development

• Mentor and develop medical directors and physicians within the oncology organisation.
• Promote scientific excellence, collaboration, accountability, and patient-focused decision-making.
• Influence cross-functional teams through scientific and medical expertise, strategic leadership, and strong stakeholder engagement.

Required Qualifications & Experience

• MD or MD/PhD required.
• Board certification in Oncology, Hematology-Oncology, or a related specialty.
• Advanced clinical training and significant experience in solid tumor oncology.
• 10+ years of clinical and/or pharmaceutical industry experience in oncology, with substantial solid tumor experience.
• Experience in global clinical development and late-phase programs.
• Demonstrated experience contributing to regulatory interactions and successful regulatory filings.
• Proven ability to provide strategic leadership within complex, matrixed organisations.
• Strong strategic thinking combined with the ability to execute effectively.
• Excellent medical judgment and scientific decision-making.
• Strong communication, influencing, and stakeholder-management skills.
• Ability to collaborate effectively across multidisciplinary and geographically distributed teams.
• High ethical standards and a strong patient-centric approach.
• Ability to operate effectively in fast-paced and evolving development environments.

Preferred Experience

• Experience leading registrational or practice-changing thoracic oncology studies.
• Experience with biomarker-driven development and precision oncology.
• Significant experience in late-stage or global oncology clinical development.
• Familiarity with complex pipeline and portfolio environments.

Compensation

The US base salary range for this position is $308,000–$462,000, depending on qualifications, experience, location, and other applicable factors.

Additional incentive compensation and benefits may be available, including performance-based bonuses, equity opportunities, retirement benefits, healthcare coverage, and paid time off.