Medical Director Clinical Development- Aging

GSK•Waltham, MA

1d•Hybrid

About The Position

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Support alignment of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP. Develop sections of core regulatory documents. Generate the data and evidence required to determine a target’s potential efficacy, safety profile, key areas of 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 Establish and maintain relationships with program counterparts in Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs and Statistics. Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development. Clinical Development Strategy and Study & Program Design Provide effective support and oversight of R&D evidence generation strategy, plan, and activities to ensure patient safety and on-time, in-full study delivery. Contribute to the study team discussions on indication planning and 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, study protocols, and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance). Bring clinical expertise 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. Clinical Leadership Accountable for leading the Clinical Matrix Team (CMT) for a program. Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study. Represents the CMT at Early/Medicine Development Teams or clinical study at CMT. Actively leads the end-to-end clinical development strategy for an early program and may contribute to later stages. Serve as the primary Clinical 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 and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board. Assist with clinical evaluation of business development opportunities Stay abreast of advancements in research, clinical trial methodologies, competitive environment, and regulatory space in the relevant disease area to maintain GSK’s competitive edge. Identify and highlights transformational opportunities, where projects can offer highly significant benefit to patients in ways not possible with existing approaches. Gather and supports the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile (MP). Consistently contribute to solving study and overall clinical development challenges. Demonstrate ability to influence others at project, departmental and inter-departmental levels, as appropriate Creating Innovative Scientific and Technical Solutions Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches to science and technical solutions. Promote an environment for others to generate ideas for improvement and proactively drives innovation, beyond taking advantage of opportunities that arise. Influencing and Inspiring Others and Managing Conflict Consistently achieves 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. 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. Manage conflicts effectively and independently, negotiating mutually acceptable solutions. Enterprise Mindset, Strategic Thinking and Navigating Ambiguity 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. Analyses, interprets and critically evaluates data, information, and digital content to interpret complex information, anticipate obstacles and identify potential solutions. Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions.

Requirements

Medical Degree
Completion of a formal postgraduate clinical training, clinical residency or specialty training in Internal Medicine, Pathology, etc
Demonstrated experience in clinical trial conduct, including medical monitoring, safety review, and clinical data interpretation
Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
Ability to apply clinical judgement to support study design, patient safety, and real-time medical decision-making within a structured clinical development framework
Experience operating effectively within cross-functional matrix teams in a pharmaceutical, biotechnology, or academic clinical trial environment
Strong scientific communication skills, with the ability to translate clinical data into clear insights for internal and external audiences

Nice To Haves

Experience with research and development across different areas of human disease-relevant biology and clinical specialties beyond a single organ
Completion of advanced specialty training, fellowship or country-equivalent higher-level qualification leading to recognition as a medical specialist through formal certification, board certification, or country specific professional designation
Experience in pharmaceutical or biotechnology clinical development across early phase studies
Clinical experience in relevant specialty and/or relevant therapeutic areas, with direct exposure to clinical research or drug development in industry or postgraduate work
Robust knowledge of aging research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
Knowledge of and experience in the execution of clinical and/or translational studies including generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems.
Experience working with global regulatory agencies and managing global clinical trials in relevant disease area
Prior experience contributing to regulatory interactions (e.g., IND submissions, scientific advice, NDA/MAA filings)
Demonstrated experience engaging with Key External Experts (KEEs), investigators, and scientific collaborators in aging disease areas
Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.
Experience in contributing to IND/CTA, NDA, BLA, or MAA submissions

Responsibilities

Support alignment of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP.
Develop sections of core regulatory documents.
Generate the data and evidence required to determine a target’s potential efficacy, safety profile, key areas of 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
Establish and maintain relationships with program counterparts in Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs and Statistics.
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 strategy, plan, and activities to ensure patient safety and on-time, in-full study delivery.
Contribute to the study team discussions on indication planning and 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, study protocols, and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance).
Bring clinical expertise 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 Clinical Matrix Team (CMT) for a program.
Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study.
Represents the CMT at Early/Medicine Development Teams or clinical study at CMT.
Actively leads the end-to-end clinical development strategy for an early program and may contribute to later stages.
Serve as the primary Clinical 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 and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
Assist with clinical evaluation of business development opportunities
Stay abreast of advancements in research, clinical trial methodologies, competitive environment, and regulatory space in the relevant disease area to maintain GSK’s competitive edge.
Identify and highlights transformational opportunities, where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
Gather and supports the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile (MP).
Consistently contribute to solving study and overall clinical development challenges.
Demonstrate ability to influence others at project, departmental and inter-departmental levels, as appropriate
Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches to science and technical solutions.
Promote an environment for others to generate ideas for improvement and proactively drives innovation, beyond taking advantage of opportunities that arise.
Consistently achieves 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.
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.
Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
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.
Analyses, interprets and critically evaluates data, information, and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions.