Global Development Lead, Early Clinical Development, Internal Medicine

ROLE SUMMARY

The Global Development Lead (GDL), Internal Medicine RU (IMRU) will be the thought leader driving clinical research for the expanding area of cardiometabolic diseases  candidate will be responsible for creating the overarching strategy for early clinical development programs with a focus on innovative design, medical and scientific excellence, and the highest ethical standards.

The GDL will apply deep medical and clinical knowledge to translate clinical research ideas into high-quality decision‑making data, working closely with subject matter experts from statistics, clinical pharmacology, and other team members. The GDL serves as a single clinical development point of contact to the Research Project Leader for each assigned project. The GDL will integrate scientific knowledge and operational expertise to ensure creativity, excellence, and integrity in clinical development.

The GDL also serves as principal contact on medical and safety issues for all study execution lines, study managers, external collaborators, and study sites during conduct of clinical trials, and manages timely delivery of clinical study reports and support appropriate interpretation and communication of clinical trial data, including scientific publications, abstracts, and presentations. The candidate will support preparation of regulatory documents (INDs, CTAs, and aggregate reports) and engage with regulatory authorities as needed throughout development and submission activities.

Hybrid Site/ Based role.

• Leads the creation of the clinical development plan from pre‑clinical stages through to proof of concept.

• Guides clinical team members to ensure excellence in development and translation of clinical research plans into efficiently delivered studies. Creative in the conception of novel study designs and collaborates with a cross‑functional team to ensure these novel designs are optimized for operational effectiveness to ensure timely and cost‑effective delivery.

• Oversees the design and execution of clinical research studies (methodology studies, clinical pharmacology studies, biomarker studies, proof of mechanism studies, proof of concept studies, medical device studies, etc.).

• Accountable for development of clinical documents (e.g., protocol, clinical report, clinical components of regulatory submissions). The GDL Lead provides final sign off for documents generated by Clinical Development Scientists across the projects they are responsible for.

• Serves as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification and tracking.

• Provides input to the operational strategy and feasibility of clinical research studies, in conjunction with Clinical Development Scientists and Clinical Operations colleagues.

• Establishes relationships with key clinical experts/sites and uses this information to advise the clinical team on site selection.

• Uses deep medical and scientific knowledge and expertise to contribute to selection of targets for progression from chemical/biologic synthesis to testing in human.

• Flexible in supporting a dynamic research portfolio; may need to manage multiple programmes in parallel, depending on the development stage of the programmes.

• Contributes to technical and protocol review committees across the portfolio.

• May also hold concomitant functional roles, for example:

  Translational Medicine Lead (TML) – Identifies / validates new / existing surrogate disease markers and novel pharmacodynamic measurements and helps translate preclinical knowledge to human decision criteria for clinical plans.

  Research Project Leader (RPL) – Accountable for establishing and executing the strategy for a research project from target or compound selection to POC. Provides operational expertise to ensure excellence of project plans and team leadership to deliver successful POCs quickly, cheaply and competitively. Interfaces with other discipline leads to ensure operational excellence in the execution of the project's strategy.

• MD or MD/PhD (or equivalent degrees) with relevant postgraduate clinical training.

• Completion of an accredited cardiology…