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

Details

Posted: 10-Oct-23

Location: BOSTON, Massachusetts

Type: Fellowship

Categories:

Pharmacy

Preferred Education:

PharmD

Additional Information:

Employer will assist with relocation costs.

About the Opportunity

Northeastern University’s Pharmaceutical Industry Fellowship Program is a two-year fellowship designed to advance the education and training of Pharm.D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. The program is a collaboration between Northeastern University and biopharmaceutical industry partners.

Our 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
• Create, present, and publish scholarly research through collaborative industry and university relationships
• Engage with faculty who participate in various interdisciplinary
• Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees

In partnership with Northeastern University, Ironwood Pharmaceuticals  is offering a two-year Clinical Development /Medical Scientific Affairs(CD/MSA) PharmD fellowship based in Boston.

We are not accepting PPS interview requests. Applicants must apply through our career portal to be considered for this position. Apply today using the link at the end of this posting!

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600® company, is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years-old. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure (SBS-IF), as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.

Responsibilities:

The purpose of the Clinical Development /Medical Scientific Affairs(CD/MSA) Fellowship is to allow the fellow to learn how to perform as an individual contributor within an evolving Clinical Development (CD) and Medical Scientific Affairs (MSA) group. The cross-functional collaboration between these two groups is essential to both the development of a commercialized therapeutic product and management of that product throughout its life cycle. The fellow will contribute to the design and implementation of complex strategic medical affairs plans for Ironwood GI products and will acquire in-depth GI disease states knowledge. The fellow will work cross-functionally with mentors to participate in key activities that will ultimately drive scientific strategy and engagement activities (eg, with key opinion leaders or patient advocacy groups) for Ironwood.

During the first year of the fellowship, the fellow will work within the clinical development team to gain experience in clinical research and study design, development, and execution, as well as study results interpretation. They will also have the opportunity to spend time in a different functional area based on areas of interest and need.

During the second year of the fellowship, the fellow be integrated within the medical affairs team to gain experience in medical strategy, Medical Legal Regulatory (MLR) review, publication strategy, content development, advisory board and congress strategy, insight generation, and more.

In both functions, the fellow will have the opportunity to work collaboratively with the other functional areas within Ironwood including regulatory, global patient safety, commercial, data sciences, and medical writing, as well as experience partner interactions and engage in vendor oversight. Additionally, the fellow will have the opportunity to precept students.

Year 1: Clinical Development and Rotation of Interest

• Develop and execute clinical trials in compliance with Ironwood processes and current regulatory guidelines and key opinion leader feedback
• Support study start-up activities
•  Develop and maintain essential trial documents such as study protocols, informed consent forms, pharmacy manuals, medical monitoring plans, data review plans, and clinical trial quality risk management plans
• Manage study and site performance via tracking of screening and enrollment activities and protocol deviations
• Support ongoing medical review of clinical trial data and data analysis and interpretation for first interpretable results
• Assist in compilation of clinical study report 
• Rotational Opportunity in an area of interest based on availability

Year 2: Medical Scientific Affairs

• Contribute to the development and maintenance of Ironwood Medical Scientific Affairs strategic plans.
• Work cross-functionally internally (commercial, medical writing, regulatory, legal, etc) to provide subject matter expertise for brand planning and content development.
• Collaborate cross-functionally to provide key MSA deliverables, such as the scientific communication platforms, publications strategy and medical communication strategy.
• Develop various types of internally or externally facing evidence-based medical content for slide decks, training material and other Medical Affairs materials.
• Cross-functional collaboration to ensure strategic alignment, medical accuracy, evidence-based representation of Ironwood GI products in US and partnered regions.
• Generate medical insights from the perspectives of the patients and providers to support development of strategic plans.
• Contribute to components of investigator-initiated research and collaborative research studies.
• Participates in intelligence gathering activities related to Ironwood strategic interests.
• Contribute to the maintenance of key medical information deliverables, including creation and updates of standing response letters, FAQ documents and any required custom responses.
• Provide comprehensive training with respect to disease state(s) and product(s) and/or investigational agents to which fellow will be assigned.
• Participate in scientific congress, advisory committee, and KOL engagement activities.
• Precept PharmD students during their co-op and/or IPPE/APPE rotations.
• Additional responsibilities to be assigned based on individual interests.

The Successful Candidate Will Provide:

• PharmD from an accredited college or university before the start of the fellowship term;
• Ability to interpret and discuss complex medical scientific data;
• Excellent project management, time management and organizational skills;
• Ability to learn new skills and apply them broadly across MSA and clinical development initiatives;
• Effective communication skills, both written and verbal; Record of medical and/or scientific publications preferred;
• Proactive individual capable of assessing needs, then creating solutions that effectively meet the need;
• Flexibility and ability to adapt quickly as company priorities change;
• Excellent interpersonal skills in order to effectively manage expectations and facilitate collaborative, working relationships;
•  A positive attitude while adjusting for different personal approaches;
• Advanced proficiency and extensive experience with Microsoft Office Suite, especially Excel, Outlook, PowerPoint, and Word;
• Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.

Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.

Additional Information:

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31, 2023

• Curriculum vitae (CV), uploaded
• Unofficial PharmD transcripts, uploaded
• Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 29th , 2023. 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

Apply Today!

About Northeastern University

Northeastern University Pharmaceutical Industry Fellowships Program offers a variety of two-year post-PharmD research fellowships. We aim to provide fellows with a dynamic environment to develop industry and academic skills to be leaders in their fields. With the rich biopharmaceutical landscape of Greater Boston as a backdrop, our programs offer the fellow an opportunity to work with innovative industry partners in a variety of specialty areas while partnering with Northeastern University faculty in the areas of research, scholarship, and teaching.

Connections working at Northeastern University