Postdoctoral Research Fellow, Ironwood Pharmaceuticals-Clinical Development
Location: Boston, Massachusetts
Internal Number: 4605355
Postdoctoral Research Fellow, Ironwood Pharmaceuticals-Clinical Development
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.
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.
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.
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.
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 [email protected] 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
Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.
Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.
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.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.