MCPHS / Moderna - Clinical Safety and Pharmacovigilance, Post PharmD Fellow
Location: Cambridge, Massachusetts
Internal Number: 7427 A
Moderna Clinical Safety and Pharmacovigilance (CSPV) is committed to global health surveillance and patient safety for advancing clinical safety with next generation mRNA science. The two-year CSPV Fellowship will provide PharmD graduates with a fast-paced immersion and introduction to the pharmaceutical industry across multiple therapeutic areas from clinical trials to marketed products. As integral members of the Moderna team, fellows will acquire practical experience through direct engagement with subject matter experts, participate in cross-functional team collaborations, and benefit from valuable networking and mentorship opportunities.
The fellow will engage in diverse projects from a benefit-risk analysis perspective including:
Contribute to Clinical Safety Science and the clinical trial portfolio, individual case assessments, safety monitoring, medical review, and health authority requests
Participation in Real World Evidence programs to address postmarket commitments, assess disproportionality, and evaluate safety signals
Understand the Signal Management Process including exposure to safety governance, data analytics, routine and postmarketing surveillance
Develop Aggregate Reports and understand the landscape of pre and post product submission activities including developmental, annual, and periodic safety reports
Two Year CSPV Fellowship Timeline:
Clinical Trials/Post Marketing
Real World Evidence
Longitudinal (Choose 1 Core Rotation from Year 1)
The Core and Elective Rotations are 3 months each, and the Longitudinal Rotation is 9 months.
The fellow will have the opportunity to spend several months in an optional elective of their choosing: Global Regulatory Sciences, Clinical Development Operations, or Medical Affairs.
To be considered for an interview, please complete a fellowship application on the MCPHS SMApply application portal. Visit https://mcphs.smapply.io/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via email to schedule interviews.
The MCPHS application portal will open up on October 2, 2023. Applicants must upload the following application materials to the online portal by November 17, 2023:
Letter of intent
Unofficial college transcript
Contact information for three references. References will receive an electronic recommendation form to complete separately.
Incomplete applications WILL NOT be reviewed. Interviews CANNOT be scheduled until these materials have been submitted. Please keep in mind that this is a competitive process and applicants are encouraged to complete their applications as soon as possible.
Three recommendation evaluation forms must be submitted no later than November 27, 2023, via the online portal. This is NOT a letter of recommendation but an online form that the reference will need to complete.
Rolling Application Review & Interviews
All submitted applications will be reviewed on a rolling basis. Interviews will also be offered on a rolling basis and opportunities are limited. Priority will be given to those applicants who apply early, well in advance of the deadline.
Rolling interviews will begin mid-October with pre-screens and a mixture of interview rounds, and will conclude in December at the end of the ASHP Midyear Clinical Meeting. Candidates will be notified if selected for an interview.
ASHP Midyear & Onsite Interviews
The fellowship program will be conducting in-person interviews at the ASHP Midyear Clinical Meeting in Anaheim, CA. Applicants are strongly encouraged to attend. Candidates attending in-person will not be able to interview without registering for both ASHP and PPS. Please refer to the ASHP & PPS website for registration details.
Top candidates may be invited for interviews at the sponsoring company’s location pending COVID – 19 restrictions.
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, MCPHS in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than December 13, 2023.
Final candidates will be required to go through additional screening / onboarding as required by MCPHS.
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis. Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy at the commencement of the program.
Candidates must have strong written and verbal communication skills and a strong interest in pursuing a career within the biopharmaceutical industry.
All candidates must have authorization to work in the United States throughout the duration of the one or two year fellowship. No visa sponsorship will be provided (i.e., TN, H-1B, STEM OPT, etc.).
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.