Postdoctoral Research Fellow

Postdoctoral Research Fellow

About Northeastern:
Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.

Our locations—in Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahant—are nodes in our growing global university system. Through this network, we expand opportunities for flexible, student-centered learning and collaborative, solutions-focused research.

Northeastern's comprehensive array of undergraduate and graduate programs— in a variety of on-campus and online formats—lead to degrees through the doctorate in nine colleges and schools. Among these, we offer more than 195 multi-discipline majors and degrees designed to prepare students for purposeful lives and careers.

About the Opportunity:

Eidos Therapeutics, a subsidiary of BridgeBio Pharma

Eidos is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, acoramidis (AG10), is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company's focus on scientific excellence and rapid execution aims to translate today's discoveries into tomorrow's medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

This two-year Fellowship Program in collaboration with Northeastern University and Eidos is designed to provide Doctor of Pharmacy graduates an opportunity to gain in-depth experience in the biopharmaceutical industry within Regulatory Affairs at Eidos. The Pharm.D. fellow will have an opportunity to gain specialized and in-depth training in distinct areas of Global Regulatory Affairs including Regulatory Strategy; Labeling; and Advertising and Promotion. During the second year of the program the fellow may be eligible for rotation(s) in the areas of Clinical Development, Clinical Operations, and Medical Affairs while continuing to develop further in global regulatory affairs. Specific opportunities may vary depending on the interests of the Pharm.D. fellow as well as the needs of the department.

The Northeastern University Pharmaceutical Industry Fellowship Program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:

Develop teaching skills through participation in our Teaching and Learning Seminar series

Facilitate small and large group didactic education in partnership with a faculty mentor

Utilize a layered learning model in experiential education by co-precepting students on pharmacy practice experiences including Northeastern's unique co-op program

Create, present, and publish scholarly research through collaborative industry and university relationships

Engage with faculty who participate in various interdisciplinary graduate programs including biotechnology, nanomedicine, immunology, health informatics, and drug discovery

Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees

Responsibilities:
The structured program will provide a cumulative set of skills that will help facilitate a smooth transition to a successful career after the fellowship.

The program consists of a 2-year assignment within the Regulatory Affairs team and may be eligible for rotation within Clinical Development, Clinical Operations, and Medical Affairs. The PharmD Fellow will work remote and work on-site at Eidos in San Francisco, CA.

Regulatory Strategy Primary Objectives

Manage, develop, and implement regulatory strategy in support of Eidos development programs

Support the planning, preparation and execution of high-quality regulatory submissions (e.g. CTA/IND and amendments, annual reports, initial license applications (NDS/MAA, etc.) and supplements/variations)

Develop and maintain knowledge of ICH, GCP, GMP, and other relevant global guidelines to ensure compliance of regulatory strategies and submissions

Work in cross-functional teams including clinical, statistics, medical affairs, commercial, and nonclinical groups to help operationalize regulatory strategy

Support regulatory interactions with regulatory bodies including preparation of meeting requests and briefing documents

Global Labeling Primary Objectives

Gain in-depth knowledge of labeling regulations regarding Company Core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), and Structured Product Labeling (SPL)

Support development of regulatory labeling strategy and the negotiation and maintenance of competitive labeling with global Health Authorities

Maintain core labeling documents

Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends and work with cross-functional team to ensure that the regulatory labeling strategy is aligned with the global regulatory strategy

Assist in preparation of responses to labeling-related queries from Health Authorities

Advertising and Promotions Primary Objectives

Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, PhRMA guidelines, company policies and established precedents and recommend revisions/actions that achieve fair balance.

Support the review and approval of promotional and non-promotional materials in a cross-functional promotional review committee that includes commercial, medical affairs, and legal

Coordinate timely and accurate review of materials for submission to FDA

Support regulatory reviewer for the promotional review committee to ensure regulatory compliance for all communications

Qualifications:
Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts and/or California.

Preferred Qualifications:
Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at Eidos and Northeastern.

Strong interest in pursuing a career at Eidos and BridgeBio

Strong verbal, written communication, interpersonal, listening, and organizational skills

Ability to work in a diverse environment

Demonstrated ability to adapt to changing priorities and work effectively

Sense of urgency and perseverance to achieve results

Unquestionable ethics, and professional integrity

Salary Grade:
10

Additional Information:
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 1st , 2021:

1. Curriculum vitae (CV), uploaded
2. Unofficial PharmD transcripts, uploaded
3. Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 29th, 2021. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam, GSK).

Address cover letter and three LORs to:
J. Andrew Orr-Skirvin, PharmD, BCOP

Clinical Professor, School of Pharmacy

Chair, Department of Pharmacy & Health System Sciences

Director of Pharmaceutical Industry Fellowship Program

360 Huntington Ave, 140TF R218

Boston, MA 02115

Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.


To apply, visit https://careers.pageuppeople.com/879/cw/en-us/job/507707

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