VP, Head Clinical Development Oncology
Collegeville, PA, USA | Leading Pharmaceutical / Biotech Company
Industry:Pharmaceutical / Biotech
Job Description:54 people have viewed this job
The Head of Clinical Development is the senior clinical development expert of the Oncology Therapeutic Area (TA) with oversight for the development strategies across all programs of the Oncology asset portfolio. The Head of clinical development has direct line function responsibility for all clinical personnel including physicians, clinical scientists in the TA, and Disease Strategy Leads (DSLs) who drive cross-asset strategy. He/she works in a matrix role to support Early Development Teams (EDTs) for preparing programs for entry into clinical development and Medicine Development Teams (MDTs) for driving clinical strategy for late stage assets.
Further, the Head of clinical Development chairs the Protocol Review Forum (PRF) ensuring highest level quality for all TA clinical protocols. He/she is a member of the Portfolio Review Committee (PRC) overseeing asset progression across the portfolio and participates in governance committee reviews for R&D assets. He/she reports to the TA Head of Oncology.
The Head of Clinical Development provides clinical development expertise, strategic leadership, Oncology disease area expertise, and Prescriber Insight for a Therapeutic Area Unit (TAU), at the TA portfolio level. He/she plays a pivotal role in setting up disease area strategies, and in ensuring the quality and robustness of the medicine vision, clinical development plans and the integrated evidence plans for the TA assets in order to support the development, approval, commercialization and patient access to differentiated medicines with proven value and with a positive return on investment for GSK. HUPs contribute to Medical Governance at the organizational level.
• Work across boundaries In partnership with development communities (EDLs, DPU Heads, and MDLs, Medical, VEO Commercial), the Head of Clinical Development provides input on clinical plans, medical governance at a TA level and ensure appropriate and adequate clinical resourcing; In partnership with Franchise he/she defines disease area strategies and priorities, ensures patient focus and robust evidence package to support successful commercialization and patient access to GSK medicines; In partnership with GCSP, he/she is accountable for safe and ethical conduct of studies at the TA level.
• Release energy The Head of Clinical Development leads a team of empowered and motivated clinical development staff, creates an environment where real conversations, healthy challenge and innovation is encouraged to enable effective decision-making. He/she creates a compelling vision and achieve great alignment around the work that needs to be done to deliver the TA pipeline and takes responsibility for managing issues as they arise i.e. finds and delivers solutions.
• Develop capability and talent He/she champions Clinical Excellence at the TA level through talent identification, recruitment, management and development of a team of high performing clinical staff (physicians and clinical scientists), and implement plans to address current and future capability needs
• Drive performance He/she ensures timely and high quality delivery of Innovative clinical trials including all documents and submissions at the TAU level, lead clinical trial innovation and optimization efforts to drive consistency, efficiency and teamwork across programs level.
• Live our values He/she is the single point of accountability for medical governance at the TA level. HUPs ensure adequate clinical oversight of clinical research initiatives, and provide a global and objective viewpoint of safety and efficacy by cultivating and sustaining a culture of openness and transparency with patient well-being as the key driver in decision-making
Global Requirements and Local Requirements
Ensure that Medical Governance for the TA is conducted in compliance with all GSK Policies, GSK SOPs, and applicable global and local regulatory guidance (GCP). The HUP is accountable to ensure that all physicians and clinical staff are conducting activities according to GCP and are fully trained and aware of these requirements.
The Head of Clinical Development is accountable to ensure that medical governance is considered for non-clinical issues and activities and to address any items, which might impact clinical conduct or patient safety in study. He/she is accountable to ensure safety issues are escalated to the appropriate TA and GMG level and to communicate to TA medical and clinical staff items of importance related to clinical conduct or patient safety.
EXPERIENCE / ACCOUTABILITIES
Accountable for Clinical Components of Medicine Development of all assets in TA:
o Provides a single Clinical Development/Medical point of contact for the TA and its portfolio to the leadership of the MDTs, DPUs, the preclinical function leads, as well as Medical Affairs, Commercial, Health Outcomes and other relevant functional partners in establishing disease area strategy and E2E medicine vision;
o Leads pipeline delivery by ensuring accuracy, quality and timeliness of CDPs, as well as clinical components of required regulatory and market access submissions, throughout the life cycle;
o Leads project oversight to ensure timely, efficient, and compliant delivery of clinical activities according to GSK metrics and policies, working with the PCPS TAU lead.
o Provides advice and guidance on specific clinical development, marketed product management, and safety/efficacy issues
Accountable for Medical Governance
• Provides clinical/medical leadership, advice, and guidance for the accountable PPLs to ensure overall safety of study subjects and scientific integrity of GSK clinical trials
o Supports/Foster interactions with the Global, Regional, or Local Medical Affairs Leaders in their accountability for Medical Governance of interactions with external communities about science and medicine (including the provision of medical information to healthcare professionals) and promotional practices are conducted to the highest standard
o Supports & Foster interactions with the GCSP leaders in their accountability for Pharmacovigilance to protect patient safety and wellbeing
o Ensures timely and proper disclosure of clinical research and results
Develop, manage, and allocate clinical resources across projects and programs
• Attract, retain and mentor clinical staff
• Manage clinical resource across discovery/early stage programs, late stage projects, marketed product programs, due diligence activities, and other clinical activities within the TAU according to the priorities of the portfolio
Enhance delivery & improve end-to-end pipeline productivity and IRR
• A clear disease area strategy, medicine vision and OneCDP/IEP
• excellent medical governance of all clinical trial activities
• robust scientific engagement of external stakeholders
• effective and dynamic clinical resource allocation especially in high priority projects
Drive simplification and reduce complexity across R&D
• Fully outsourced clinical studies where appropriate
• Explore opportunities for simplification at TA level and organizational level