Register for the 2023 Personnel Placement Service (PPS) to request an interview.

Details

Posted: 22-Sep-23

Location: Cambridge, Massachusetts

Type: Fellowship

Categories:

Graduate Program

Pharmacy

Job Setting:

Pharmaceutical Science/Industry

Salary Details:

Fellows will receive a competitive stipend and benefit package, including comprehensive health insurance

Required Education:

PharmD

Additional Information:

Employer will assist with relocation costs.

Clinical Development, Clinical Scientist

About Clinical Development, Clinical Scientist Fellowship

Clinical development is responsible for the architecture of clinical trial concepts, protocol development, study start up, study execution, data review and cleaning, clinical interpretation of data, publication contributions, and serves as a clinical resource for regulatory filings and queries from authorities and sites. Within clinical development, clinical scientists play a  role on the clinical trial working group (CTWG). They work to help align study goals and strategy within the clinical trial working group, , serve as a resource for investigators on patient eligibility, safety, and protocol questions, and partner cross-functionally with early or late-stage clinical development, medical, and commercial teams.

Clinical Development, Clinical Scientist Fellowship Goals and Objectives

The fellow will gain hands-on knowledge of US and Global clinical development at Agios. The fellow will gain experience in clinical trial-related activities within the cross-functional clinical trial working group and gain an extensive understanding of the responsibilities of a clinical scientist. The fellow will:

• Develop a strong clinical development knowledge base and be able to apply their skills practically.
• Obtain well-rounded knowledge of country or region-specific clinical trial processes.
• Cultivate strong communication and project management skills.
• Collaborate cross-functionally with various departments within the company and with key external collaborators as a partner in the product development process.

 Clinical Scientist Program Design

The fellow will join  our dynamic Clinical and Translational Development (CTD) function in the Research and Development organization at Agios and will be given a plethora of opportunities to learn the business of rare disease drug development. Agios already has a network of MCPHS PharmD Fellows, who are seen as key contributors to their respective functions and have shown the positive impact that they can have on the company. The clinical and translational development (CTD) function and clinical scientist team is excited to welcome their first fellow to contribute to the success of the organization and learn from our enthusiastic and diverse group of researchers.

Year 1: Clinical Development

• Learn the purpose and goals of a clinical scientist across different phases of clinical development.
• Gain an understanding of the structure and function of a clinical trial and the roles and responsibilities of a clinical scientist within study start up, execution, and closeout.
• Collaborate with key team members and functions who are part of clinical trial working groups at Agios, such as Clinical Operations, Regulatory Affairs, Data Management, and Safety for assigned trial(s).
• Become familiar with clinical trials being run at Agios (Phase 1-3, Adult and Pediatric, and clinical pharmacology).
• Independently review contracts, study documents, clinical data and protocol deviations for assigned trial(s).
• Perform initial review of key study documents.
• Develop a working knowledge of GCP and ICH.

Year 2: Clinical Development

• Contribute to initial authoring and/or review of key study documents (Protocol, Informed Consent Form (ICF), Investigator Brochure (IB), Lab Manual, etc.).
• Respond to site queries and regulatory authority queries in conjunction with clinical scientist (CS)
• Contribute to clinical data review activities across an indication/molecule.
• Assist in development of clinical data review standards and timelines with cross-functional teams.
• Play a role in preparing for functional review of program milestones and data supporting milestones such as interim analyses, database locks, publications, clinical advisory boards and clinical study reports (CSR), etc. as needed for assigned trial(s).

Serve as a clinical contributor for other relevant activities (analysis plans, filing, data monitoring committee, clinical advisory boards, etc.) as needed for assigned trial(s).

Application Procedure

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
• Curriculum vitae
• 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. 

Recommendations

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.

Offer Dates

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.

Onboarding

Final candidates will be required to go through additional screening / onboarding as required by MCPHS.

Eligibility

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.).

Visit our website for more information: http://www.mcphs.edu/pharmdfellow

About MCPHS / Agios

Agios is a biopharmaceutical company passionately committed to applying scientific leadership in the field of cellular metabolism to transform the lives of patients with genetically defined diseases. 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. Agios believes 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. Agios intends to apply a deep understanding of metabolism, coupled with the ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way genetically defined diseases are treated. Agios has a dynamic culture, which supports our employees’ unwavering commitment to science and patients. World-class founding and leadership teams with the experience and track record to provide the insights required to develop groundbreaking medicines lead a... group of exceptional employees. We pride ourselves on fostering an interconnected environment that encourages creative scientific collaboration across disciplines. Our unique culture, combined with the commitment and passion of our team, reflect our belief in an “other side of possible” approach to our challenges and our work.

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Connections working at MCPHS / Agios