Clinical Development Manager Jobs in Raleigh, NC

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

GSK is seeking a Director, Clinical Development to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on respiratory disease or immunology. You will work within project teams to plan, execute, and deliver clinical development activities and support medical governance up to and including registrational studies. This role is pivotal in driving GSK's mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency.

About RIIRU:

The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies).

Key Responsibilities:

This role will provide YOU opportunity to lead key activities to progress your career, these responsibilities include some of the following:

• Contribute to project team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to support vital deliverables including the Target Medicine Profile (TMP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning.
• Provide effective support to the development and execution of the IES, including oversight of R&D evidence generation activities to ensure patient safety and study delivery.
• Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input (ie patients, evidence generation, regulators, payors, pharmacovigilance, etc.).
• Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols, amendments, investigator brochures, clinical study reports etc.
• Input to, and may lead, 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.
• Act as clinical lead for a clinical study, taking a key role on the Study Leadership Team (SLT) and serve as clinical point of contact for a clinical study on the Clinical Matrix Team (CMT), across the internal matrix and a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators).
• Make significant contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
• Evaluate specific business development activities, including due diligence and contributes to the implementation and embedding of strategic/organizational initiatives in Clinical Development, adopting innovative methodologies and processes including digital tools and technology.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK's competitive edge.

In addition to the above, YOU will:

• Demonstrate flexibility and adaptability in changing environments and ability 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, proactively generating ideas for innovative improvement and promoting an environment for others to be creative.
• Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
• Analyze, interpret and critically evaluate data, information and digital content to interpret complex information, anticipate obstacles and identify potential 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.

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in scientific field or Nursing required
• Experience in clinical research and drug development, including experience relevant to respiratory diseases or immunology
• Experience in respiratory or immunology late-stage clinical development

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Advanced Degree: MD, PhD, PharmD
• Medical degree with formal specialty training and board qualification/registration in Pulmonary Medicine, Pulmonary & Critical Care, Respiratory Medicine or Allergy/Immunology.
• Experience working in the global pharmaceutical or biotechnology industry within respiratory diseases or immunology.
• Experience leading global clinical trials and contributing to NDA, BLA, or MAA submissions.
• Experience in latestage respiratory or immunology drug development, including design, initiation, execution, and closure of Phase 2 and Phase 3 clinical trials.

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at -usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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