Clinical Lead – Nephrology, Cardiology or Endocrinology – CVMED
Responsible for creating the overarching strategy for the early clinical development of the programs under his/her purview with a focus on the highest ethical standards, innovative design, medical execution and interpretation.
- Leads clinical development strategy and program execution of a research project; leads translation of pre-clinical observations into clinical experiments and results.
- Partners with clinical lead(s) for renal, diabetes, or vascular disease from the primary care, specialty care, and/or emerging markets business units to develop success criteria for proof of concept (POC) studies for each candidate, and ensures buy-in and alignment from their respective leadership.
- Responsible for leading the development of methodologies to support proof of pharmacology, proof of mechanism and proof of concept studies under the remit of translational research.
- Applies medical and clinical development knowledge to translate clinical research ideas into high quality clinical candidate and target go/no-go decisions.
- Works with statistics and other clinical staff (e.g., clinical pharmacology) in the review and interpretation of data; accountable for overall quality and timeliness of analysis and reporting.
- Clinical Lead is the single point of contact for Clinical to the Research Project Leader (RPL) for each assigned project.
- Integrates scientific knowledge and operational expertise to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
- Serves as principal contact on scientific and medical issues for Dev Ops, study managers/monitors and external collaborators and study sites during conduct of the trial.
- Establishes relationships with key clinical experts/sites, and uses these relationships to help establish collaborations and enhance Pfizer's medical/scientific reputation.
- Be outward facing including learning/applying best practice from the external environment and being a key point of contact for clinical research.
- Drives scientific and technical excellence.
- Inputs to the selection of targets at Lead Development to be progressed to clinical testing, by either the Target Exploration or Best-in-Class units
- Motivates and engages colleagues in an understanding of disease and excitement in an indication and mechanism.
- In collaboration with the RPL and the Research Project Team ensures that the translational research plan supports the strategy for clinical development.
- With input from the Translational Medicine Lead, is responsible for the creation of each program's biomarker strategy and plan to POM.
- Leads the creation of the clinical development plan from PRISM through to outcome of POC.
- Guides the clinical research scientist to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
- Oversees the design and execution of clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, medical device studies etc) including development of outline/core elements prepared by the clinical research scientist.
- Accountable for development of clinical documents (e.g., protocol, clinical report, clinical components of regulatory submissions). Clinical lead provides final sign off for documents generated by Clinical Research Scientist(s) across the projects they are responsible for.
- Serves as a resource to the clinical research scientist in the development of outline/core elements and for clinical review and safety oversight.
- Provides input to the operational strategy and feasibility of clinical research studies, in conjunction with the CPM and clinical research scientist; accountable for final decision.
- Establishes relationships with key clinical experts/sites and uses this information to advice the CPM and clinical research scientist on site selection
- Builds relationships with external investigators to promote scientific discussions, smooth operational delivery and avid interest in Pfizer's success.
- Be outward facing including learning/applying best practice from the external environment and being the key point of contact for clinical research.
- Creative in the conception of novel study designs and collaborates with the clinical research scientist and CPM to ensure these novel designs are optimisedoptimized for operational effectiveness to ensure timely and cost effective delivery.
- Maintains a high degree of awareness of the external environment and ensures appropriate external innovations in scientific and medical aspects are applied to the Research portfolio.
- In collaboration with the Clinical Research Scientist, tracks emerging study data to ensure appropriateness of the chosen subject population and proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality.
- Understands and applies novel techniques and works with the platform lines to overcome potential barriers to ensure novel study data is captured and analysedanalyzed in a timely and effective manner.
- Maintains medical and scientific expertise in novel techniques and educates others in their application.
In collaboration with the clinical research scientist, tracks emerging safety profile of the drug, keeping the Clinical Research Head informed of relevant changes in the safety profile and recommend appropriate courses of action (e.g., additional monitoring, intermediate doses, discontinuation, etc.) should they occur in the assigned studies.
- Flexible in supporting a dynamic research portfolio; may need to manage two to four programs in parallel, depending on the development stage of the programs
- Contributes to technical review committees across the portfolio.
- Contributes expertise to building appropriate translational pharmacology models spanning from idea through to POC
- Uses personal medical and scientific knowledge and expertise to input to selection of targets for progression from LD to testing in human May also hold functional roles, for example:
- Translational Medicine Leader- Identifies / validates new / existing surrogate disease markers and novel pharmacodynamic measurements and helps translate preclinical knowledge to human decision criteria for clinical plans. These markers will reduce the cost of drug R&D.
- Research Project Leader- 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.
Training & Education Preferred:
- MD or MD/PhD with relevant postgraduate clinical training; board¬ eligibility/certification in Nephrology.
- Established record in execution of clinical trials in the pharmaceutical industry environment; experience in managing complex projects. Prefer 3-5 yrs experience.
- Comprehensive understanding of the drug development process with particular emphasis on phase Ia/Ib and IIa/IIb clinical trials.
- Scientific excellence; possesses deep knowledge of diabetes, integrated metabolism and related areas.
- Superior clinical ability with relevant disease area knowledge and experience.
- Demonstrated 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.
- Demonstrated understanding of the complexities and recent developments in the relevant disease/technical area, and ability to apply such knowledge to drug development.
- Comprehensive understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines.
- Understands the value of project management and is able to leverage these tools for project delivery.
- Ownership of budgets.
- Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results. Behavioral Competencies:
- Acts Decisively - Makes timely and effective decisions by applying business and financial acumen. Makes decisions that translate into competitive advantage.
- Acts with urgency to deliver and removes barriers that hinder productivity Timely Decision Making – Makes effective decisions in a timely manner, often with incomplete information and under tight deadlines and pressure; able to evaluate risk and use this to inform decision making; does not prevaricate; actively seeks solutions to problems. Entrepreneurial and innovative; takes managed risks; thinks out of the box; challenges the status quo and dogma.
- Builds effective teams that can succeed in the adversity of drug discovery. Able to take teams through all stages of team development and willing to address matters that affect team performance. Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and successes uses and builds on the expertise of others; fosters open dialogue; embraces diversity in the team; lets people finish and be responsible for their work; defines success in terms of whole team; maintains momentum through adversity.
Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site.
Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.
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