Senior Director, MD Global Development Lead, Early Development
Pfizer
Global Clinical Lead – Clinical Scientist
Telix Pharmaceuticals Limited
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Define and drive the clinical development plans for Fibroblast Activation Protein (FAP) imaging assets, ensuring alignment with Telix’s broader asset strategy and commercial objectives.
- Partner closely with Global Program Heads, Regulatory Affairs, Medical Affairs, and Translational Medicine to ensure clinical trial objectives are integrated into the overall development strategy and reflect the needs of diverse stakeholders.
- Oversee the development of clinical study plans from concept through to protocol finalization, ensuring scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements.
- Lead the creation and review of essential clinical documentation—including informed consent forms, imaging charters, study manuals, and regulatory dossiers—in collaboration with medical writers and cross-functional teams.
- Provide expert clinical input into key regulatory and scientific documents, including Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global regulatory submissions (e.g., INDs, BLAs, NDAs, MAAs).
- Lead the review, interpretation, and quality control of clinical data, including efficacy, safety, and imaging endpoints, to ensure data integrity and support decision-making across the development lifecycle.
- Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and strategic collaborators to communicate program progress and clinical insights.
- Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts, consultants, and vendors to inform clinical strategy and enhance program visibility.
Requirements
- Medical degree (MD) or doctoral degree (PhD) in a relevant scientific discipline is required.
- Therapeutic Area Expertise: Demonstrated experience in oncology or nuclear medicine is required, with a strong understanding of the clinical and scientific landscape.
- Clinical Development Experience: 5 years of industry experience in clinical development, with a proven track record of leading clinical programs through early-phase development. Experience in early-stage clinical trial design and execution is strongly preferred.
- Regulatory Knowledge: Solid understanding of global clinical trial methodology, regulatory frameworks, and submission processes. Experience preparing and submitting regulatory documents (e.g., INDs, CTAs) and engaging with health authorities (e.g., FDA, EMA) is preferred.
- Leadership and Project Management: Demonstrated success in leading cross-functional teams and managing complex clinical development programs from concept through execution.
- Strategic and Scientific Acumen: Strong knowledge of clinical trial design, data interpretation, and the ability to translate scientific insights into strategic development plans.
