Senior Medical Director, Clinical Science -Solid Tumor

Role Summary

Senior Medical Director, Solid Tumor

Responsibilities

• Clinical Development team participation and leadership: Leads the Global Development Team (US, EU, Japan) managing both the US/EU Development Team and the Japan Development team for assigned compounds. Oversees the clinical scientist leading these teams, ensuring proactive identification of contingencies, risks, and strategies to address obstacles.
• Directs Development Team strategy and deliverables: Oversees the Development Strategy, Clinical Development Plan and Clinical Protocols; assesses scope, complexity, and size influencing budget; maintains a state-of-the-art development plan aligned with regulatory requirements; develops contingency plans.
• Responsible for high impact global decisions: Monitors and interprets data from studies, assesses medical implications, and makes recommendations affecting regional/global development, including go/no-go decisions or modifications to development plans or study designs.
• Synopsis / Protocol Development, Study Execution, & Study Interpretation: Drives activities related to preparation/approval of synopses, protocols, and conduct of clinical studies; advises clinical scientists and ensures successful project completion; interprets data within medical significance to patients.
• Trial Medical Monitoring: Oversees medical monitoring activities, assesses protocol conduct and subject safety; evaluates overall safety information with Pharmacovigilance.
• External Interactions: Directs regulatory interactions and engagement with clinical development and key opinion leaders; provides leadership and acts as advisor to clinical scientists in these activities.
• Due Diligence, Business Development and Alliance Projects: Identifies and evaluates BD opportunities, conducts due diligence, develops/negotiates clinical development plans for alliances or in-licensing; interfaces with potential partners; represents clinical science on internal teams.
• Leadership, Task Force Participation, Upper Management Accountability: Interacts with research divisions and TPNA/TPEU; represents clinical science on priority task forces; leads TGRD internal and cross-functional teams; hires, manages, mentors, and conducts performance reviews.

Qualifications

• MD or internationally recognized equivalent plus 7 years of clinical research experience in pharma, CRO, or academia, including 3‚Äì4 years of late-stage clinical development experience.
• Training and experience in Hematology/Oncology and/or Medical Oncology, especially solid tumor malignancies, is highly preferred.
• Experience conducting/leading clinical trials in immune-based therapies and/or antibody-drug conjugates is highly preferred.
• Experience leading a clinical development team/matrix team with multi-regional responsibilities; development experience beyond US/EU is a plus.
• NDA/MAA/Submission experience preferred.
• Excellent communication and influencing skills with the ability to engage executives and external partners.
• Experience leading highly trained medical/scientific professionals is preferred.

Skills

• Superior communication, strategic, interpersonal, and negotiating skills.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities across multinational cultures.

Knowledge

• Therapeutic area knowledge relevant to mechanisms of action of compounds in remit.
• Regional/global Regulatory requirements.
• GCP/ICH.
• Emerging research in designated therapeutic area.

Travel Requirements

• Ability to drive to or fly to various meetings or client sites, including overnight trips; some international travel may be required.
• Requires approximately 15 - 25% travel.