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Clinical Development Director, Respiratory Diseases

GSK
Mississauga, CAN
Full-time
Director · 3+ years experience
Remote
Discovered 2 days ago
gcp

Full Job Posting

Skills

  • Analytical Thinking, Business Acumen, Change Management, Clinical Research, Clinical Trial Designs, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Risk Management, Strategic Thinking
  • 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.
  • 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. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
  • 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 GSK's 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 GSK. In 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.

Qualifications

  • Bachelor’s degree in a science related field
  • 3 years of Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
  • Robust knowledge of ICH guidelines, GCP, FDA requirements, regulatory and reimbursement data requirements in responsible area
  • Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)
  • Demonstrated experience using new learning and digital tools to create innovation in other areas
  • Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
  • Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions.
  • Analytical Thinking, Business Acumen, Change Management, Clinical Research, Clinical Trial Designs, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Risk Management, Strategic Thinking
  • 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.
  • 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. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
  • 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 GSK's 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 GSK. In 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.

Preferred Qualifications

  • PhD or PharmD degree valuable but not required
  • Experience leading matrix teams with a strong reputation of inspiring and motivating high performance
  • Previous experience as a Clinical science Lead (CSL) at GSK, or a similar position in another company
  • Significant experience in respiratory clinical drug development with an understanding of the disease area, the underlying biology and potential therapeutic targets.
  • Work Arrangement
  • This role is home based in Canada, preferably in Ontario.
  • Are you ready to bring your clinical development experience to a team that’s making a real impact? Join us, and together we will push boundaries and create better outcomes for people affected by respiratory diseases. Apply today and let’s get ahead of disease together.

Responsibilities

  • This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
  • Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery
  • Contributing to regulatory interactions including clinical trial applications, briefing documents, presentations, addressing questions and responses
  • Contributing to the writing of the clinical study synopsis (CSP), study protocols, clinical study reports (CSR) and any subsequent study abstract and manuscript publications
  • Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
  • Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP
  • Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
  • Developing and maintaining relationships with matrix counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
  • Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development
  • Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs
  • Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Sciences
  • Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
  • Why You?

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