Vice President, Global Clinical Lead - Solid Tumor

Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP).

Provides leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads.

Accountabilities

• Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.
• Partners with key functions and leaders to drive alignment on global clinical research and development strategy.
• Leads the Global Development Team managing both the US/EU Development Team and the Japan/China Development team for assigned compounds.
• Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols.
• Responsible for high impact global decisions: interpreting data from ongoing internal and external studies, assessing medical and scientific implications and making recommendations.
• Plans clinical development strategies in context of medical/clinical significance considering current treatments, standard of care, and unmet medical need.
• Provides strategic input into global development strategies and plans for all compounds in OTAU.
• Primary interface with Medical Affairs team for strategy and to support product commercial efforts.
• Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation.
• Responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds.
• Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.
• Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders.
• Conducts due diligence evaluations of clinical development plans for potential alliances and/or in-licensing opportunities.
• Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.

Qualifications

• MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology.
• Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies.
• Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies.
• Experience in conducting and/or leading multiple clinical trials involving immune based therapies.
• Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment.
• Demonstrated ability to foster a high-performance culture and build organizational capabilities.
• Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment.
• Previous experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions.
• Clinical Development experience beyond US/EU.
• Solid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA, EMA, and others.
• Multiple NDA/MAA submission experience.
• Proven ability to lead and manage highly trained medical, scientific, and technical professionals.
• Superior communication, strategic, interpersonal and negotiating skills.
• Enterprise level leadership with the ability to inspire, motivate and drive results.
• Excellent communication both verbally and in writing and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities across multinational business cultures.

Travel Requirements: Willingness to travel to various meetings or client sites, including overnight trips. Several international travels may be required. Requires approximately 25-35% travel.