Full-Time

Global Clinical Development Lead

Targeted Alpha Therapeutics

Posted on 7/9/2024

Telix Pharmaceuticals

Telix Pharmaceuticals

201-500 employees

Develops targeted radiation therapies for cancer

Biotechnology
Healthcare

Senior

Remote in USA

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • Medical degree required
  • Clinical experience in medical oncology or nuclear medicine is essential
  • Minimum of 5 years of experience in clinical development
  • Strong knowledge of clinical trial design, methodology, and regulatory requirements
  • Successful leadership and project management of clinical development programs
  • Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred
Responsibilities
  • Lead development of clinical development plans for targeted alpha therapeutics
  • Collaborate with global program heads, regulatory affairs, medical affairs, and translational medicine teams to ensure alignment of clinical trial objectives with overall asset strategy
  • Develop clinical study plans from concept to synopsis to full protocol, ensuring alignment with the Company’s objectives, and the needs of regulatory authorities, healthcare professionals, patient groups, guidelines committees and payors
  • Develop – in collaboration with relevant cross-functional teams and medical writers – clinical study documentation including, but not limited to informed consent documents, imaging charters, study manuals and final regulatory dossiers.
  • Lead clinical scientific input into documentation including investigator brochures, IMPDs, safety reports (e.g. DSURs, PSURs, and SUSARs), clinical study reports and regulatory documents such as briefing packages, INDs, BLAs, NDAs and MAAs
  • Lead the analysis, review, and quality control of clinical data (e.g. study-related, aggregated) including efficacy, safety, and imaging data to ensure accuracy and quality
  • Prepare and deliver presentations, proposals, and reports for senior management, partners, and other stakeholders
Telix Pharmaceuticals

Telix Pharmaceuticals

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Telix Pharmaceuticals develops and sells products for diagnosing and treating cancer and rare diseases using targeted radiation. Their products help healthcare providers make better treatment decisions and offer personalized therapies for conditions that lack effective treatments. The company focuses on areas like prostate and kidney cancers, glioma, sarcoma, and bone marrow conditioning. Telix has a strong global supply chain to ensure their products are available to healthcare institutions and professionals. Unlike many competitors, Telix emphasizes sustainability, patient care, and ethical practices in its operations. The goal of Telix Pharmaceuticals is to improve the quality of life for patients by providing advanced diagnostic and therapeutic solutions.

Company Stage

IPO

Total Funding

$14.8M

Headquarters

Melbourne, Australia

Founded

2015

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

2%
Simplify Jobs

Simplify's Take

What believers are saying

  • Illuccix®'s European approval paves the way for increased revenue in prostate cancer imaging.
  • Acquisition of ImaginAb enhances Telix's innovation capabilities and expands its therapeutic pipeline.
  • Cyclotron capacity expansion in Brussels South boosts production of radioisotopes and patient doses.

What critics are saying

  • Potential delays in Illuccix®'s European launch due to administrative national phase hurdles.
  • Integration challenges from ImaginAb acquisition may disrupt Telix's operations and focus.
  • Dependence on new cyclotron installation in Brussels South could impact production timelines.

What makes Telix Pharmaceuticals unique

  • Telix focuses on molecularly-targeted radiation therapy for prostate, renal, and glioblastoma cancers.
  • The company integrates sustainability and ethical practices into its operations and patient care.
  • Telix's global supply chain ensures worldwide availability of its diagnostic and therapeutic products.

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Benefits

Annual Performance Bonus

Equity-Based Incentive Program

Paid Vacation

Paid Wellness Days

Hybrid Work Options

Remote Work Options

INACTIVE