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 at Pfizer. The 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 candidate will lead clinical development strategy and program execution of research projects with a particular focus on cardiometabolic diseases and associated conditions (e.g., cardiovascular disease, heart failure, renal impairment, obesity, diabetes, etc.), and lead translation of pre-clinical observations into clinical experiments and Phase 1/2 studies designed to demonstrate proof of pharmacology, proof of mechanism and proof of concept for new candidate medicines.

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. The candidate will manage 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.

The GDL establishes and cultivates collegial relationships with key clinical experts, academic entities, and clinical trial sites, and uses these relationships to help establish collaborations and enhance Pfizer's medical/scientific reputation. The GDL will partner collaboratively across the enterprise, coordinating and integrating contributions from Discovery & Early Development lines and broader Pfizer Research & Development colleagues for the internal medicine therapeutic area to progress drug development programs.  The GDL will ensure alignment and support from leadership stakeholders to streamline end-to-end clinical development plans. Overall, the Global Development Lead is positioned uniquely at Pfizer at the interface between bench and bedside, and plays a pivotal role in the ideation and maturation of leading edge clinical science applied to drug development.

ROLE RESPONSIBILITIES

• 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). 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 programs in parallel, depending on the development stage of the programs
• 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.

QUALIFICATIONS

• MD or MD/PhD (or equivalent degree(s)) with relevant postgraduate clinical training. 
• Completion of an accredited cardiology fellowship is strongly preferred 
• Minimum of 5 years of industry experience in drug development or relevant biomedical research experience
• Proven track record of scientific scholarship and achievement
• Preference for established record in execution of clinical trials in the pharmaceutical industry environment.  Firm understanding of the drug development process with particular emphasis on early clinical development.
• Scientific excellence; possesses deep knowledge of integrated metabolism biology and metabolic diseases such as cardiovascular/cardiometabolic disorders, obesity, diabetes, and cachexia .

• Ability to design, initiate and conduct effective clinical studies applying novel principles as appropriate, and integrating these plans into a cohesive overall clinical development strategy.
• Strong understanding of the complexities and current developments in the relevant disease/technical area.
• Firm understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines.

• Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results.
• Skilled communicator and team leader
• Ability to navigate a complex matrixed environment and manage teams that are diverse in terms of expertise, background, and geography.

PREFERRED QUALIFICATIONS

• Board eligibility/certification in Cardiovascular Disease or a related sub-specialty preferred.
• Active medical license preferred

• The GDL will be a matrix manager of project teams, specifically heading the clinical subteam of the global medicines team for each asset assigned.
• The GDL may be asked to lead above asset working teams or subteams thereof, matrix managing small or large teams comprised of colleagues from across business lines.
• The GDL may also serve as an RPL, which requires matrix management of teams varying in size from 3-20 based on stage of development and project complexity.
• May also directly manage from 1-3 colleagues of varying experience and seniority, including other global development leads and clinical development scientists, depending on business needs and personnel staffing.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful

This is a Hybrid Site/ Based role

The annual base salary for this position ranges from $274,500.00 to $457,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Medical