Agios, in collaboration with MCPHS University, offers a unique fellowship program to promote the role of the Doctor of Pharmacy (PharmD) within the biopharmaceutical industry. A fellow gains extensive experiences through various practical activities in both industry and academic settings, which could enhance the potential for accelerated career development.
About Regulatory Affairs-Clinical Strategy
Regulatory Affairs–Clinical Strategy (RA–CS) professionals are responsible for developing the regulatory strategy and leading global health authority interactions to support global drug development from pre-IND through registration and life cycle management. They manage the planning, coordination, and execution of high quality regulatory submissions of original applications (i.e. NDAs/MAAs, INDs/CTAs) and any subsequent major amendments, supplements, and variations. The RA–CS team interfaces with a diverse cross-functional team to ensure regulatory strategy is aligned with the overall development and corporate strategy.
Fellowship Goals and Objectives
The goal of the Agios RA–CS Fellowship Program is to provide the fellow with hands-on global experience in order to develop a comprehensive understanding of regulatory's role in the drug development process from early stage to post-marketing.
Fellowship objectives include:
Develop a strong global regulatory strategy skillset while actively contributing to regulatory planning and submissions
Obtain well-rounded knowledge of country specific regulatory processes
Cultivate strong communication, leadership, and project management skills
Collaborate cross-functionally with numerous departments within the company as a partner in the drug development process
As an integrated member of the RA–CS team at Agios, the fellow will be provided with a variety of opportunities for growth and development within the oncology portfolio. Through an intensive and cultivating environment, the fellow will gain hands-on global regulatory experiences to further enhance their professional knowledge. Assuming increasing responsibility over the two years, the fellow will obtain a deep comprehension of regulatory’s roles, responsibilities, and day-to-day tasks as part of a cross-functional team to support global drug development.
To be considered for an interview at Midyear, please register for both ASHP Midyear and PPS and then complete a fellowship application on the MCPHS Fluid Review application portal. Visit https://mcphs.fluidreview.com/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via email to schedule interviews.
Before ASHP Midyear Clinical Meeting
Applicants must upload the following application materials to the online portal by December 2, 2019:
Letter of intent
Unofficial college transcript
Contact information of three references for their recommendations.
Incomplete applications WILL NOT be reviewed. ASHP Clinical Midyear Meeting 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.
After ASHP Midyear Clinical Meeting
The three letters of recommendation must be submitted by the three provided contacts no later than December 16th
Top candidates will be invited for onsite interviews at Agios headquarters. Final candidates will be required to go through additional screening / onboarding as required by MCPHS University.
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis, with interviews at the American Society of Health Systems Pharmacists (ASHP) Midyear meeting.
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.
Employer will assist with relocation costs.
Additional Salary Information: Fellows will receive a competitive stipend and benefit package, including comprehensive health insurance
About MCPHS University/Agios
Agios is a biopharmaceutical company passionately committed to applying our scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic disorders. Metabolism is a complex biological process involving the uptake and assimilation of nutrients in cells to produce energy and facilitate many of the processes required for cellular division and growth. We believe that dysregulation of normal cellular metabolism plays a crucial role in many genetic diseases. We believe Agios is a first mover in using cellular metabolism, an unexploited area of biological research with disruptive potential, as a platform for developing potentially transformative medicines. We intend to apply our deep understanding of metabolism, coupled with our ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and rare genetic disorders are treated.