You are now leaving ironwoodpharma.com. This link will take you to
a website to which our privacy policy does not apply. You are solely
responsible for your interactions with that website.
Ironwood selected as one of Boston Globe's Top Places to Work.
Ironwood named honoree in the Museum of Science's "Invented Here" awards.

Career Openings


Clinical Scientist

ID: 1575
Department: Clinical Research
Location: Cambridge Headquarters
# of Openings: 1

Description

It’s an exciting time for Ironwood. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.” This new way of doing business will enhance our agility and innovation, and empower our teams to make a bigger impact on our patients and on our industry.

The new Ironwood will focus on accelerating the growth of our marketed product Linzess® (linaclotide) and advancing the development of our innovative pipeline of treatments for GI diseases and abdominal pain. Following completion of the separation, the Clinical Scientist position will be part of the new Ironwood. The role will remain as described here.

Position description:

The primary responsibility of the Clinical Scientist, Clinical Research will be to provide medical expertise and leadership necessary to advance one or more of the Company’s lead drug candidates through Phase I, II and III clinical trials. The Clinical Scientist/ Associate Director, Clinical Research, will drive the design, planning, and implementation of clinical program/s and study protocols for drugs that are in all phases of development, and will play a key role in supporting related regulatory activities. This clinical expert/scientist will also support attainment of corporate strategic objectives by contributing their clinical, scientific and development expertise to business development initiatives, co-development partnerships, and development plans for pre-clinical programs.

 

Responsibilities:

  • Lead/support the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy

  • Be the recognized clinical expert for these development program/s both within and external to Ironwood

  • Provide extensive medical and scientific input into the design of clinical trials for these development programs

  • Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget

  • Assist in the preparation of clinical study protocols and FDA/EMA documents (eg., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documents

  • Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities

  • Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trials

  • Establish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and study protocols

  • Collaborate with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development

  • Support pre-clinical development planning, patho-mechanistic insight and translational medicine efforts to effectively advance pipeline programs

  • Provide clinical, scientific and development expertise to business development initiatives as needed

 

Basic qualifications:

  • An MD or DO degree preferred

  • Medical expertise in internal medicine (specialty training and board certification, eligibility or expertise in gastroenterology].

  • Relevant pharmaceutical/biotech-industry experience in clinical research and development, and/or clinical/scientific consulting with substantial experience as an investigator in clinical trials ideal.

  • Demonstrated expertise in evaluation and analysis of clinical/scientific data, ideally with successful publications thereof.

  • General knowledge of regulatory requirements such as apply to clinical drug development

 

Preferred qualifications:

  • A PhD and/or translational medicine expertise a significant plus (not required)

  • Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment

  • Persuasive, effective and flexible in personal interactions at all levels, with strong oral and written communication capabilities

  • Strong project management and problem-solving skills

  • Displays sense of urgency, and a willingness to roll up sleeves to get the work done


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





Are you a returning applicant?

Previous Applicants:

If you do not remember your password click here.

Back to Search Results

New Search


Powered By Taleo


You are now leaving ironwoodpharma.com. This link will take you to
a website to which our privacy policy does not apply. You are solely
responsible for your interactions with that website.