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Sr. Manager, Regulatory Lead, Early Clinical Development

Pfizer


Location:
Cambridge, MA
Date:
08/22/2017
2017-08-222017-09-20
Job Code:
1607776
Pfizer
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Job Details

Job Title Sr. Manager, Regulatory Lead, Early Clinical Development

JobID 1607776

Location: Cambridge, MA

Description Lead regulatory strategy and operations in a group designing novel technology enabled measures of disease for clinical trials.



We are currently searching for a skilled professional to join the Pfizer Innovative Research Lab, a novel digital research group, developing technology-based measurements of disease as a Regulatory Lead. PfIRe is a transformative vision for Pfizer. The goal of the organization is to construct systems in which digital continuous/dynamic measurements in patients are used for diagnosis and health state monitoring . The mission of the PfIRe Lab is to solve key business problems using dynamical measures, advanced-STEM platforms and a collaborative network of external stakeholders, regulators and internal enterprise-wide colleagues to support a digital therapeutic pipeline.



The Regulatory Lead will work with cross-functional teams to develop and implement regulatory strategy, work with project teams and the Worldwide Regulatory Strategy group to develop plans for data and submission packages to US and international regulatory agencies. Responsibilities include actively contributing to the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on digital development project teams, active involvement in the writing and review of regulatory submissions and interfacing with authorities, coordinating all aspects of regulatory submissions and proactively keeping updated on regulatory requirements and emerging trends in the regulatory attitude and regard for digital measurements worldwide. The successful candidate will function as a contributing member of motivated and engaged teams who are responsible for aligned execution across a number of projects.



**ROLE RESPONSIBILITIES**

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

• Key contributor to design, management and operationalization of the PfIRe Lab Projects from the perspective of regulatory strategy. These include human biology studies, methodology studies in healthy volunteers, clinical research collaborations at a small number of academic and multispecialty medical centers, and validation studies for the PfIRe Lab.

• Partners with colleagues in PfIRe Lab, Clinical Pharmacology, Biostatistics, Development Operations (including IPM and mClinical), Regulatory, Data Standards and Legal to ensure excellence in development and translation of these clinical research plans into efficiently delivered evidence for effectiveness of novel measures in preparation for use in regulatory submissions.

• Development of a long-range regulatory strategy in the PfIRe Lab.

• Establish relationships with key internal teams and external regulatory science experts and institutions to ensure implementation of best regulatory science thinking and guidelines into clinical studies development plans and regulatory strategy.

• Flexible and entrepreneurial in supporting the uncertainties of development in the portfolio.

• Manage regulatory team and contribute to the regulatory strategy

• Make sure company is on track for timely submissions of regulatory documents

• Review/communicate current and upcoming regulatory requirements.

• Provide innovative and strategic regulatory leadership to project teams in early and late stage digital development.

• Work proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners to plan and execute an effective global regulatory strategy in alignment with the overall digital development plan

• Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks

• Prepare the team and lead negotiations with FDA and other health agencies

• Provide regulatory due diligence as required for effective project progression



**QUALIFICATIONS**

• Bachelor's in a Life Sciences related field (Master's preferred)

• Years of experience: 7+ MA or 9+ BA regulatory experience in the pharmaceutical industry

• Experience in interfacing with FDA

• Extensive experience with IND submissions

• Deep knowledge and understanding of global regulatory requirements and environment

• Thorough knowledge of the drug development process

• Demonstrated strategic thinking and implementation in drug development

• Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities

• Strong interpersonal and leadership skills

• Demonstrated ability to build consensus and drive change across the organization

• Able to be entrepreneurial and focus relentlessly on delivering success at all costs on tight and immutable timelines

• Lives a culture of "can do" and always finding solution space



**EEO Statement**

**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.



**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.



**Additional Offer Details:**



+ **Last Date to Apply for Job:** September 19, 2017

+ **Grade: 13**

+ Eligible for Employee Referral Bonus



A career at Pfizer offers opportunity, ownership and impact.



All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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