Senior Director Clinical Lead, Internal Medicine Research Unit (MD)

ROLE SUMMARY

The Senior Director Clinical Lead (CL) in the Internal Medicine RU (IMRU) will be a thought leader driving innovation in clinical research for projects from LD through POC stage in broad categories of metabolic disorders (e.g., cardiometabolic disorders, diabetes, NASH, cachexia and anorexia). The CL will apply medical and clinical knowledge to translate clinical research ideas into high-quality clinical strategies that will generate decision-making data, in close collaboration with subject matter experts from statistics, clinical pharmacology, and other team members. The CL will work with other team members to develop translational biomarker plans during the preclinical stage to ensure that each team has a robust strategy in place by the FIH endorsement milestone. The CL will integrate scientific knowledge and operational expertise to ensure creativity, excellence, and integrity in clinical development. The CL serves as a single clinical development point of contact to the Research Project Leader for each assigned project. The CL 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 CL 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 CL will partner collaboratively across the enterprise, coordinating and integrating contributions from Worldwide Research & Development lines and Global Product Development colleagues for the internal medicine therapeutic area to progress drug development programs. S/he will ensure alignment and support from leadership stakeholders to streamline end-to-end clinical development plans. Overall, the Clinical 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

• Uses medical and scientific knowledge and expertise to contribute to selection of targets for progression from chemical/biologic synthesis to testing in human.
• Creates the clinical development plan from pre-clinical stages through clinical 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 the Clinician and Operations Manager 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, biomarker studies, proof of mechanism studies, proof of concept studies, medical device studies, etc.) including development of outline/core elements prepared by Clinicians or other clinical team members.
• 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 Clinicians across the projects they are responsible for.
• Serves as a Medically Qualified Individual (MQI) for assigned studies, 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 the Development Director, Operations Manager, and Clinician; accountable for final decision.
• Establishes relationships with key clinical experts/sites and uses this information to advise the clinical team on site selection.
• Flexible in supporting a dynamic research portfolio; may need to manage multiple programs in parallel, depending on the development stage of the programs.
• 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

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 outcomes and create business impact.

• MD or MD/PhD with relevant postgraduate clinical training.
• 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.
• >4-6 years of relevant experience
• Scientific excellence; possesses deep knowledge of integrated metabolism biology and metabolic diseases such as diabetes, NASH, cachexia, eating disorders and/or cardiovascular/cardiometabolic disorders.
• Excellent communication skills.
• 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, and skillfully applies this knowledge to drug development.
• Understanding of clinical regulatory requirements, and knowledge of GCP and ICH guidelines.
• Ability to effectively facilitate meetings and conduct complex, strategic conversations.
• Ability to review and understand emerging data and proactively implement measures to ensure delivery of quality study results.
• Skilled communicator and team leader, able to clearly articulate ideas and integrate feedback.
• Ability to navigate a complex matrixed environment.

PREFERRED QUALIFICATIONS

• Board eligibility/certification in Internal Medicine, with subspecialty in gastroenterology, geriatrics, palliative care, cardiology or nephrology (or analogous relevant subspecialty training) preferred.

Other Job Details:

• Eligible for Relocation Package: YES
• Eligible for Employee Referral Bonus: YES

#LI-PFE

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

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 work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical

#LI-PFE