Global Clinical Development Lead, Targeted Alpha Therapeutics

5+ years

Not Disclosed

Remote, USA

10 Dec. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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About Telix Pharmaceuticals

Telix Pharmaceuticals is a dynamic and fast-growing radiopharmaceutical company with a global footprint. Headquartered in Australia and with offices in Belgium, Japan, Switzerland, and the United States, we are driven by our mission to deliver the promise of precision medicine through targeted radiation.

At Telix, we develop and commercialize products designed to improve the quality of life for people living with cancer and rare diseases. You will play a key role in supporting the international rollout of our approved prostate cancer imaging agent and advancing our late clinical-stage product portfolio addressing significant unmet needs in oncology and rare diseases.

See Yourself at Telix: Global Clinical Lead

We are seeking an experienced Global Clinical Lead to join our Clinical Strategy and Innovation team. In this pivotal role, you will design and execute clinical trials for cutting-edge radiopharmaceutical products in solid tumors. This is a unique opportunity to drive clinical development strategies for targeted alpha therapeutics in areas of high unmet medical need.

You will lead the clinical programs to ensure they are based on sound scientific principles and progress efficiently toward commercial realization. This includes generating robust clinical data to meet the needs of regulatory authorities, healthcare professionals, patient groups, payors, and business development partners.

The Global Clinical Lead will collaborate across a matrix organization, working closely with Global Program Leads, Clinical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, and other cross-functional teams to advance Telix’s targeted alpha therapeutic assets. Success will require an in-depth understanding of the competitive landscape and future opportunities in targeted alpha therapeutics.

Key Accountabilities

Clinical Development Strategy:
- Design and implement clinical development plans for targeted alpha therapeutics.
- Collaborate with global program heads, regulatory affairs, and medical affairs teams to align trial objectives with overall asset strategies.
Clinical Study Execution:
- Develop clinical study plans, protocols, and related documentation to meet regulatory, stakeholder, and organizational objectives.
- Oversee the creation of study documentation, including informed consent documents, imaging charters, and regulatory dossiers.
Regulatory & Scientific Leadership:
- Provide input into key regulatory submissions (e.g., INDs, CTAs, BLAs) and serve as a clinical representative in interactions with regulatory agencies (e.g., FDA, EMA).
- Lead the preparation of investigator brochures, safety reports (e.g., DSURs, SUSARs), and other regulatory documents.
Data Analysis and Reporting:
- Analyze clinical data for efficacy, safety, and imaging endpoints, ensuring data quality and accuracy.
- Prepare and deliver presentations, proposals, and reports for senior management, partners, and external stakeholders.

Education & Experience Requirements

Qualifications:
- Medical degree (MD) required, with clinical expertise in medical oncology or nuclear medicine.
Experience:
- Minimum of 5 years of clinical development experience.
- Strong knowledge of clinical trial design, methodology, and regulatory requirements.
- Experience leading regulatory submissions and interacting with agencies like FDA or EMA is highly preferred.

Key Capabilities

Industry Knowledge: Deep understanding of the nuclear imaging and therapy market, products, and technologies.
Leadership: Demonstrated success in leading cross-functional teams and advancing clinical programs.
Communication: Exceptional interpersonal, negotiation, and presentation skills, with the ability to engage diverse stakeholders effectively.
Adaptability: Self-motivated, goal-oriented, and capable of thriving in a fast-paced, collaborative environment.
Willingness to Travel: Domestic and international travel as required.

Why Join Telix?

At Telix, we believe everyone counts. We are united by a shared purpose: helping people with cancer and rare diseases live longer, better-quality lives.

Mission-Driven Innovation: Be part of a team leading advancements in precision medicine.
Collaborative Culture: Join an engaged and supportive global team that values diversity and inclusion.
Comprehensive Benefits: Enjoy competitive compensation, performance-based bonuses, equity incentives, and generous paid time off.
Growth & Flexibility: Benefit from professional development opportunities and hybrid/remote work options.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.

For details on our privacy policy, please click here.

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Global Clinical Development Lead, Targeted Alpha Therapeutics

Job Description

About Telix Pharmaceuticals

See Yourself at Telix: Global Clinical Lead

Key Accountabilities

Education & Experience Requirements

Key Capabilities

Why Join Telix?

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