Clinical Development Medical Director- Inflammation and Fibrosis

GSK, Plc.•Boston, MA

39d•$202,500 - $371,250

About The Position

The Clinical Development Medical Director- Inflammation and Fibrosis, provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The appointed individual will work within project teams to plan, execute, and deliver activities including inflammation and fibrosis translational and clinical development strategies and clinical studies. You will work cross-functionally to develop and execute clinical development plan(s) up to, and including, Proof of mechanism/Proof of concept studies. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Requirements

Medical degree from accredited medical school
Completion of a clinical residency program
Experience in clinical research and development

Nice To Haves

Board certification in Rheumatology is preferred
Experience in clinical research and development specifically with Lupus, Sjogren's Syndrome or Osteoarthritis is preferred
Deep understanding of rheumatology specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution is preferred
Experience working with global regulatory agencies and managing global clinical trials in inflammation, fibrosis, or rheumatologic indications is preferred
Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research is preferred
Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards is preferred
Experience in contributing to NDA, BLA, or MAA submissions preferred

Responsibilities

Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of IEP and CDP. Will develop sections of core regulatory documents
Generate the data and evidence required to determine a target or medicines' potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe
Define and deliver the clinical pillars of the translational table. Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP.
Seek and maintain relationships with program counterparts in Biology, Translational Science, Commercial, Research Tech, Biostatistics, Regulatory, Clinical Operations, Access, and Medical Affairs.
Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development
Provide effective support and oversight of R&D evidence generation activities to ensure patient safety and study delivery.
Contribute to the study team discussions on indication planning, incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to contribute to vital deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection.
Design clinical development plans and study protocols across all phases of development, reflecting internal and external stakeholder input (e.g. patients, evidence generation, regulators, payors, pharmacovigilance)
Develop clinical study protocols, amendments, investigator brochures, clinical study reports etc.
Input to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician. Accountable for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
Accountable for leading the CMT on an EPU program. Serve as a clinical point of contact both internally and externally for an indication of an asset indication (i.e. Pre-POC and single indication) or for a clinical study. Represent the clinical matrix team at EDT or clinical study at CMT.
Collaborate with cross-functional teams, including biology, translational, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive translational and clinical development plans. Act as Clinical Lead at study level.
Actively lead the end-to-end clinical development strategy for an EPU program and contribute to later stages. Serve as the primary point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
Serve as the primary clinical interface with the relevant internal RIIRU/GSK review board (ie Technical Review or governance) and/or Protocol Review Board.
Provide clinical evaluation of business development opportunities.
Stay abreast of advancements in immunology and rheumatology research, clinical trial methodologies, competitive environment and regulatory space to maintain GSK's competitive edge. Identify and highlight transformational opportunity where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
Gather and support the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile. Consistently contribute to solving study and overall clinical development plan problems.
Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in the EPU.
Demonstrate ability to influence others at project, departmental and inter-departmental levels, as appropriate
Able to consistently inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.
Demonstrate experience in managing conflicts effectively and independently, negotiating mutually acceptable solutions.
Consistently achieve desired outcomes through strong influencing skills including understanding others' perspectives, building trust, tailoring communications depending on the audience and using persuasive arguments to gain support.
Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions
Demonstrate enterprise mindset with effective collaboration across the matrix, able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals.
Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovation in other areas
Proactively generate ideas for innovative improvement and take advantage of opportunities that arise; promote environment for others to generate ideas for improvement