Service Medical Director leading Anaesthesia and Perioperative Medicine at Monash Health. Collaborating across departments to ensure effective healthcare delivery and patient safety standards.
About the role
- Lead the end-to-end clinical development strategy for a drug or program in immunology and fibrosis.
- Manage specific clinical development plans for product(s) and/or indication(s) in specific therapy/disease areas.
- Oversee Integrated Evidence Plan (IEP), Clinical Development Plan (CDP) and its component clinical trials; be accountable for clinical aspects of Target Medicine Profile (TMP).
- Provide strategic leadership to ensure clinical study designs align with IEP and CDP and consider scientific rationale, regulatory requirements, product development plan and commercial goals.
- Establish and deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
- Collaborate with internal teams (Commercial, Research, Regulatory, Clinical Operations, Statistics etc.) and act as the clinical point of contact for senior management.
- Contribute to strategic and organizational initiatives in Clinical Development and Business Development activities, including due diligence projects.
- Build and manage external relationships with scientific external experts to align clinical programs with business strategy and patient needs.
- Assess and mitigate risks, evaluate technical success probabilities, and identify transformational opportunities with significant patient benefits.
- Contribute to global regulatory submissions and interactions, including briefing documents and responses.
- Champion implementation of innovative methods and processes within clinical development and gain stakeholder support.
Requirements
- Medical degree and clinical medical specialty board qualification in Rheumatology or Allergy/Immunology.
- Experience in (bio-)pharmaceutical industry with experience in Rheumatology or Immunology clinical drug development.
- Experience with planning clinical development for a Rheumatology or Immunology asset and/or indication.
- Experience in drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure.
- Experience of global regulatory filings/submission.
- Experience of immunologic-mediated diseases, underlying biology, and potential therapeutic targets.
- Deep experience in Rheumatology, Autoimmune, or the Neuroinflammation space (preferred).
- Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant global market(s) (preferred).
- Experience collaborating with multiple stakeholders on complex projects (preferred).
- Record of building and maintaining strong relationships with internal and external stakeholders (preferred).
- Ability and willingness to be on-site a minimum of two days a week at a GSK US site (Upper Providence, PA or Waltham, MA).
Benefits
- Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Job title
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Degree requirement
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