Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
About the Role!
The Senior Director, Clinical Development will play an important role in working with the team to execute the global clinical development plans for INS 1007 molecule and potentially other investigational molecules.
Tasks include preparing clinical documents (e.g. protocol, study report, IND & NDA documents), providing medical oversight for investigational sites, doing research, and participating in and providing medical/scientific leadership to study team(s). This position will require working in a fast-paced, high energy, entrepreneurial environment and reports to the Vice-President of Clinical Development.
This is a non-supervisory position
Additional representative responsibilities will include, but not necessarily be limited to, the following:
Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical studies, before during and after conduct of studies, and identify/resolve issues related to study design that arise during study
Provide medical monitoring and direct interaction with investigational sites, investigators, and when appropriate Key Opinion Leaders
Provide medical expertise where needed (which may include assisting colleagues in Pharmacovigilance).
Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.
Provide program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the NDA/CTD submissions, and responses to questions from regulatory authority or EC/IRBs.
Support preparation of abstracts, manuscripts, presentations, and materials for Advisory Meetings.
Present protocols and supporting presentations at Investigator Meetings and as needed for other meetings or training purposes.
Provide medical/scientific review of statistical analysis.
Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, coding, report development and database lock processes.
Keep up to date on scientific and medical progress in the area of development and actively develops and maintain relationships with outside experts. May serve as a liaison by representing the company in outside groups.
Participate in due diligence work as needed.
Requires an MD/DO or equivalent medical degree. Specialization in pulmonary or immunological disease areas is a plus. Experience in rare or orphan diseases is highly desirable.
At least 10 years of clinical development experience in the pharmaceutical/biotech Industry is required.
Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.
Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders, within and outside of Insmed.
Must have excellent communication skills (verbal and written).
Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
Must have strong analytical skills.
Must work well both independently and in teams, have excellent time management skills and be able to work well under pressure.
Vendor management experience is a plus.
Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions.
Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
Must have a global perspective and mindset, with the ability to work effectively with colleagues from myriad of cultures, backgrounds and geographies
Up to 25% travel, both domestic and/or international, with periods of 50% and more travel.
Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.