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

Here's a revised and polished version of your job description:

About Telix Pharmaceuticals
Telix Pharmaceuticals is a fast-growing radiopharmaceutical company with a global footprint, headquartered in Australia and with offices in Belgium, Japan, Switzerland, and the United States. Our mission is to transform precision medicine through targeted radiation. We are dedicated to improving the quality of life for people living with cancer and rare diseases. Join us as we expand the international rollout of our approved prostate cancer imaging agent and advance a robust portfolio of late-stage clinical products to address unmet needs in oncology and rare diseases.

Role Overview: Global Clinical Lead

We are seeking an experienced Global Clinical Lead to join our Clinical Strategy and Innovation team. This leadership role is a unique opportunity to shape the clinical development strategy for novel radiopharmaceutical products in solid tumors, particularly targeted alpha therapeutics. You will lead the design, execution, and delivery of clinical trials that address significant unmet medical needs and drive the advancement of Telix’s assets toward regulatory and commercial success.

Key Responsibilities

Clinical Development Strategy:
- Develop comprehensive clinical development plans for targeted alpha therapeutics.
- Collaborate with global program leads, regulatory affairs, medical affairs, and translational medicine teams to align clinical objectives with broader asset strategies.
Study Design and Oversight:
- Lead the development of clinical study plans, protocols, and associated documentation, ensuring alignment with regulatory and stakeholder needs.
- Oversee the creation of essential documents, including informed consent forms, imaging charters, and study manuals, in collaboration with cross-functional teams.
Regulatory & Scientific Leadership:
- Provide clinical scientific input into key documents, such as investigator brochures, regulatory dossiers, and safety reports (e.g., DSURs, SUSARs).
- Lead regulatory submissions (e.g., INDs, CTAs) and participate in interactions with regulatory agencies, including FDA and EMA.
Data Analysis and Communication:
- Review and analyze clinical data, ensuring accuracy and quality for efficacy, safety, and imaging endpoints.
- Prepare and deliver presentations, proposals, and reports to senior management, partners, and external stakeholders.
Cross-Functional Collaboration:
- Work closely with internal teams, including clinical operations, manufacturing, business development, and medical affairs, to support the advancement of Telix’s targeted alpha therapeutic programs.

Education & Experience Requirements

Qualifications:
- Medical degree (MD) required, with clinical expertise in medical oncology or nuclear medicine.
Experience:
- At least 5 years of experience in clinical development.
- Strong knowledge of clinical trial design, methodology, and regulatory requirements.
- Proven leadership and project management skills in clinical development programs.
- Experience with regulatory submissions (e.g., INDs, CTAs) and interactions with regulatory agencies (e.g., FDA, EMA) is preferred.

Key Skills & Competencies

Market Expertise: Strong understanding of the nuclear imaging and therapy landscape, including emerging technologies and trends.
Interpersonal Skills: Excellent communication, negotiation, and relationship-building abilities.
Adaptability: Comfortable working in a fast-paced environment, managing multiple priorities, and embracing innovative solutions.
Leadership: Self-motivated and goal-oriented, with the ability to inspire and guide cross-functional teams.

Why Join Telix?

At Telix, you’ll be part of a global, interdisciplinary team united by a shared purpose: helping people with cancer and rare diseases live longer, better-quality lives.

Innovative Mission: Work at the forefront of precision medicine and radiopharmaceutical innovation.
Supportive Culture: Join an inclusive, collaborative environment where every team member is valued.
Comprehensive Benefits: Enjoy competitive salaries, performance-based bonuses, equity incentives, generous vacation, paid wellness days, and robust support for professional growth.
Flexibility: Hybrid and remote work options tailored to role requirements.

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

For more details about our privacy policy, please click here.

This rewrite highlights the role's strategic impact, clear responsibilities, and Telix’s commitment to innovation and inclusivity.

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Global Clinical Development Lead, Targeted Alpha Therapeutics

Job Description

Role Overview: Global Clinical Lead

Key Responsibilities

Education & Experience Requirements

Key Skills & Competencies

Why Join Telix?

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