Clinical Development Medical Director - Neruology
Clinical Development Medical Director - Neruology
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Job Description
Job Purpose
The Clinical Development Medical Director Neurology provides clinical and scientific insights and leadership to Respiratory Immunology and Inflammation Research Unit (RIIRU) programmes clinical and translational studies within the Early Pipeline Unit (EPU). The role will work within project teams to plan execute and deliver activities including translational and clinical development strategies and clinical studies. You will work cross-functionally to develop and execute clinical development plan(s) up to Proof of mechanism/Proof of concept studies.
Key Accountabilities / Responsibilities:
Clinical Development Strategy; Study & Program Design
- Provides effective support / oversight of R&D evidence generation activities to assure patient safety and study delivery.
- Contributes to the study team discussions on indication planning incorporates 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. May assist clinical evaluation of business development opportunities
- Designs clinical development plans across all phases of development and early phase study protocols reflecting internal and external stakeholder input (e.g. patients evidence generation regulators payors pharmacovigilance)
- Develops clinical study protocols amendments investigator brochures clinical study reports etc.
- Inputs to regulatory interactions and documents including briefing documents presentations addressing questions and responses for assigned studies and programs.
- Provides medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study together with Pharmacovigilance Physician. If physician accountability 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) on an EPU program. Serves as a clinical point of contact both internally and externally for an indication of an asset (i.e. PrePOC and single indication) or for a clinical study. Represents the clinical matrix team at early development team (EDT) or clinical study at CMT.
- Collaborates 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 leads the end-to-end clinical development strategy for an EPU program and may 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.
- Serves as the primary clinical interface with the relevant internal RIIRU/GSK review board (ie Technical Review or governance) and/or Protocol Review Board.
- Stays abreast of advancements in neurology and neurodegeneration research clinical trial methodologies competitive environment and regulatory space to maintain GSKs competitive edge. Identifies and highlights transformational opportunity where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
- Consistently contributes to solving study and overall clinical development plan problems. Analyses interprets and critically evaluates data information and digital content to interpret complex information anticipate obstacles and identify potential solutions.
- Contributes to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development.
Basic Requirements:
- Primary medical qualification (MBBS or equivalent) and completion of Neurology specialty training(CCT and fellowship or equivalent level)
- Minimum of 3 years of experience in clinical research and development (may include postgrad experience)
- Robust knowledge of neurology specific research priorities public health needs competitor landscape clinical practice trends and treatment guidelines evolution.
- Experience working with global regulatory agencies and managing global clinical trials in neurology.
- Knowledge of regulatory requirements Good Clinical Practice (GCP) and ethical guidelines for clinical research.
- Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards.
Preferred Qualifications/experience:
In the addition to the above the following will be highly desirable
- In addition to Neurologist credentials holding a higher research degree (e.g. PhD) or other demonstrable research expertise (e.g. Faculty appointments)
- Experience in contributing to NDA BLA or MAA submissions preferred
- Strong personal network across relevant scientific and clinical thought leaders institutions and consortia in neurology
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 were 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.
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.
We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0. The helpline is available from 8.30am to 12.00 noon Monday to Friday during bank holidays these times and days may vary.
Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Director
Employment Type
Full-Time
Key Skills
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