Interventional Study Scientist Medical Director

The Interventional Study Scientist Medical Director will lead the scientific design of interventional clinical studies, medical governance, and interpretation of results within the Medical Affairs organization (non-regulatory label-directed programs) for assigned asset(s)/indication(s). This role will partner closely with the GML and GMT and is the single point accountability for translating the evidence strategy set by the GMT into appropriate interventional studies. The study designed is expected to fulfill a strategic objective of the clinical development and integrated evidence plan. This role is pivotal in shaping data generation strategies and ensuring clinical trials are conducted with the highest standards of quality, ethics, and efficiency. The successful candidate will have deep expertise in industry-sponsored clinical research, global medical affairs, commercial acumen, and cross-functional team leadership. They will oversee multiple projects independently and may be responsible for study development and implementation across an entire therapeutic area.

Key Responsibilities:

Strategic Leadership:

• Translating the strategic vision for the therapeutic area and asset set forth by the GMT into Medical Affairs interventional studies and aligning them with GSK's overarching goals.

• Lead the design of interventional medical affairs clinical trials from Phase I through Phase IV including integrated input from internal/external experts, thought leaders and patients.

• Ensure alignment of interventional study strategies with regulatory requirements and industry best practices.

• Ensure that study objectives are consistent with decision criteria in the clinical development plan and integrated evidence plan.

• Ensure appropriate incorporation of design of study into protocol.

• Present the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct.

Scientific oversight for the study:

• Oversee benefit-risk of the study.

• Ensure study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.

• Review clinical data and study conduct to assure patient safety and scientific integrity. This would include ongoing review of protocol deviations and implementation of remedial plans.

• Oversee medical governance for the study including medical monitoring.

Outputs for the study:

• Interpretation of study data to create the scientific content of Clinical Study Report (CSR).

• Preparation of study results for abstracts, posters and presentations for scientific meetings, congresses, external journal publications.

• Preparation of clinical content of regulatory documents and interaction with global regulatory authorities for the study (if needed).

• Provides input into and reviews other relevant study document including the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM).

• Provides scientific content for other study specific documentation (e.g. slides for site/monitor/investigator training).

• Collaborate with cross-functional teams to ensure seamless execution and delivery of clinical programs, in particular the clinical development operations and biostatistics teams, as well as third party vendors.

• Monitor and manage study progress, ensuring compliance with protocols, regulatory requirements, and GSK standards.

Team Leadership:

• Foster a collaborative and innovative culture within the interventional studies team.

• Provide guidance and support for professional development and career growth of team members.

• Partner with the Study Delivery Lead and Project Manager (in Clinical Operations) to ensure optimal delivery of the study.

• Maintain close collaboration with various functions including drug safety, regulatory affairs, biostats, TAs (GMLs and GMT) in medical affairs and clinical trial operations at the study level.

Regulatory and Compliance:

• Ensure that all interventional studies are conducted in accordance with GCP, and other relevant regulatory guidelines.

• Maintain oversight of all regulatory submissions and interactions related to interventional studies.

• Ensure robust quality control and assurance processes are in place for all clinical trials.

Stakeholder Engagement:

• Serve as the primary point of contact for internal and external stakeholders regarding the study.

• Collaborate with key opinion leaders, investigators, and external partners to enhance study design and execution.

• Communicate study progress, challenges, and outcomes to senior leadership, the GML/GMT, and other relevant stakeholders.

Innovation and Continuous Improvement:

• Identify and implement innovative approaches to improve the efficiency and effectiveness of interventional studies.

• Stay abreast of industry trends, emerging technologies, and new methodologies in clinical research.

• Promote a culture of continuous improvement within the interventional studies team.

Basic Qualifications:

• Advanced degree in a relevant scientific discipline (MD, PhD, PharmD, or equivalent).

• 10 + years of experience in clinical research, with 5 + years in a leadership role overseeing interventional studies.

• Led at least three large-scale interventional clinical trials from design to execution with demonstrated impact.

• 5+ years of experience as a medical monitor, overseeing at least three interventional clinical trials in compliance with ICH-GCP, FDA, EMA, and other global regulatory requirements.

• Experience analyzing and synthesizing data from multiple sources to drive decision-making, demonstrated by at least three instances of data-driven recommendations impacting trial design or execution.

• 5+ years of experience leading cross-functional line or matrix teams at the study level, including managing direct reports or leading virtual teams.

• Evidence of strong leadership skills with at least three examples of cross-functional collaboration on setting direction, obtaining alignment, and engaging for results resulting in strategic outcomes.

• Leading the resolution of at least two significant trial challenges, such as protocol amendments, patient recruitment obstacles, or regulatory compliance issues, resulting in improved study timelines, data quality, or regulatory approvals as a measure of strategic think and problem-solving.

• Experience managing multiple priorities in a fast-paced environment, overseeing simultaneous management of at least three studies or strategic initiatives.

Preferred Qualifications:

• Physicians and specialization in relevant therapeutic area preferred.

• Experience collaborating with regulatory authorities.

• Familiarity with innovative approaches in clinical trial execution.

• Exposure to working with key opinion leaders, investigators, and external partners.

• Experience in developing scientific content for publications and regulatory submissions.

• Understanding of digital tools and AI-driven methodologies for evidence generation.

• Prior experience with cross-functional teams in a pharmaceutical or biotech setting.

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