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Exec Director, Clinical Development

Company: Regional Recreation Corporation of Wood Buffalo
Location: Bridgewater
Posted on: April 8, 2021

Job Description:

Exec Director, Clinical Development in Bridgewater, New Jersey - Careers at *NJCHQ - NJ Corporate Headquarters Skip Branding Insmed Footer

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            • PULMOVANCE --- Liposomal Technology
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                    • Investor FAQs Contact Us Insmed Incorporated -- 2020 All rights reserved. Contact Us
                      • Culture
                        • Mission & Vision
                        • Careers
                        • Responsibility
                          • Patients
                            • ARIKAYCE --
                            • Resources
                              • Science
                                • Pipeline
                                • PULMOVANCE --- Liposomal Technology
                                • Diseases
                                • Clinical Trials
                                • Investigator-Initiated Research
                                  • About
                                    • History
                                    • Management Team
                                    • Board of Directors
                                    • Global Healthcare Compliance
                                      • Investors
                                        • Events & Presentations
                                        • Stock Information
                                        • News Releases
                                        • SEC Filings
                                        • Analyst Coverage
                                        • Corporate Governance
                                        • Email Alerts
                                        • Investor FAQs -- Insmed 2020. All Rights Reserved.Terms of Use Privacy Policy Exec Director, Clinical Development in Bridgewater, New Jersey - Careers at *NJCHQ - NJ Corporate Headquarters Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Welcome page Returning Candidate? Log back in! Exec Director, Clinical Development Location US-NJ-Bridgewater ID 2021-2229 Job Function Clinical Development Company Description About Insmed: Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency. Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families. Overview About the Role: The Executive/Senior--Director, Clinical Development will play an important role in working with the team to execute the global clinical development plans for of Treprostinil Palmitil for PAH and other related indications. 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). In addition, a highly strategic view is required. Strong leadership skills are a must for this highly visible opportunity. This position will require working in a fast-paced, high energy, entrepreneurial environment and reports to the Vice-President of Clinical--Development. This role is a supervisory position and has direct reports. Responsibilities 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 a global strategic view to the program. Works as a liason between our company and the KOL community.
                                          • Establish a working and collegial working environment with key KOLs
                                          • 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 feedback for activities related to review of data for interim analysis or blinded data reviews.
                                          • 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.
                                          • Contribute to the strategic development of early and late stage clinical programs.
                                          • Contribute to process creation and SOP writing and updating as needed.
                                          • Participate in due diligence work as needed. Qualifications About You:
                                            • Requires an MD degree, preferably board eligible. Specialization in pulmonary or cardiology diseases is a plus.
                                            • At least 7--years of clinical development experience in the pharmaceutical/biotech Industry.
                                            • Familiarity with the therapeutic area (PAH) is a must
                                            • 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.
                                            • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
                                            • 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: Collaboration, Accountability, Passion, Respect and Integrity
                                            • 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 cultures, backgrounds and geographies Additional Information Travel Requirements:
                                              • Up to 30% travel, both domestic and/or international 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. Options Apply for this job online Apply Share Email this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Connect With Us! Not ready to apply? Connect with us for general considerationClick here to get started. Application FAQs Software Powered by iCIMS
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Keywords: Regional Recreation Corporation of Wood Buffalo, Trenton , Exec Director, Clinical Development, Executive , Bridgewater, New Jersey

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