Senior Vice President, Clinical Research Initiatives
2 weeks ago
Position Overview:
The Senior Vice President of Clinical Research Initiatives will spearhead the strategic development, innovation, execution, and oversight of all interventional clinical trials within the medical affairs division. This includes the formulation and implementation of a comprehensive portfolio of medical affairs-sponsored Phase IV studies.
This crucial position requires a forward-thinking leader with extensive knowledge in clinical research, regulatory standards, and medical affairs Phase IIb/IV studies, along with adeptness in managing cross-functional teams.
The SVP will guarantee that all interventional studies are executed to the utmost standards of quality, ethics, and efficiency, leveraging the latest advancements in clinical trial methodologies to propel GSK's pipeline of groundbreaking therapeutics.
Key Responsibilities:
Strategic Direction:
Formulate and execute the strategic vision for interventional studies in alignment with GSK's broader objectives.
Lead the design and implementation of interventional medical affairs clinical trials spanning Phase I to Phase IV across various therapeutic areas.
Ensure that interventional study strategies are in sync with regulatory requirements and industry best practices.Operational Oversight:
Manage the operational facets of interventional studies, including planning, budgeting, resource distribution, and timeline management.
Collaborate with cross-functional teams to ensure the smooth execution and delivery of clinical programs, particularly with clinical development operations and biostatistics teams, as well as external vendors.
Monitor and oversee study progress, ensuring adherence to protocols, regulatory standards, and GSK policies.Team Development:
Build, mentor, and lead a high-performing team of clinical research professionals. Cultivate a collaborative and innovative environment within the interventional studies team. Provide guidance and support for the professional growth and career advancement of team members.
Regulatory Adherence:
Ensure that all interventional studies comply with GCP, FDA, EMA, and other pertinent regulatory guidelines. Maintain oversight of all regulatory submissions and interactions associated with interventional studies. Establish robust quality control and assurance processes for all clinical trials.
Stakeholder Collaboration:
Act as the primary liaison for internal and external stakeholders regarding interventional studies. Partner with key opinion leaders, investigators, and external collaborators to enhance study design and execution. Communicate study progress, challenges, and outcomes to senior leadership and other relevant stakeholders.
Innovation and Improvement:
Identify and implement innovative strategies to enhance the efficiency and effectiveness of interventional studies. Stay informed about industry trends, emerging technologies, and new methodologies in clinical research. Foster a culture of continuous improvement within the interventional studies team.
Qualifications:
MD, PharmD, PhD, or BSc in a scientific discipline. Proven experience in clinical research within a global context. Demonstrated success in leading and managing large-scale interventional clinical trials across multiple therapeutic areas.
In-depth knowledge of GCP - ICH and Clinical Development, registration, and commercialization processes, along with an understanding of human experimentation laws and regulations.
Experience in leading teams of over 10 individuals, with a focus on coaching and developing high-performing teams. Proven ability to work in a leadership capacity with various stakeholders, including R&D, Commercial, and senior leaders.
Preferred Qualifications:Experience as a medical monitor or Clinical Project Manager. Exceptional interpersonal, communication, influencing, and negotiation skills to facilitate optimal collaboration between central R&D, local organizations, and internal and external stakeholders, including senior management. Strong business acumen and agility to drive business outcomes in a dynamic environment.
Proficient in collaborative matrix management, focusing on leading diverse groups to achieve shared goals. Strong financial, budget, and project management skills, along with a proven ability to lead through organizational changes. Excellent networking skills with the ability to engage and cooperate with others effectively.
Why Join GSK?
GSK is a global biopharmaceutical company dedicated to uniting science, technology, and talent to advance health outcomes. We focus on preventing and treating diseases through vaccines, specialty, and general medicines, with an emphasis on the science of the immune system and innovative data technologies.
Our success is driven by our people, and we strive to create an environment where individuals feel inspired, valued, and included. If you share our ambition to make a positive impact on global health, we invite you to explore opportunities with us.
As an Equal Opportunity Employer, we welcome all talent and are committed to fostering an inclusive workplace. We believe in an agile working culture and encourage you to discuss flexible working arrangements with our hiring team.
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