- 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 expertise where needed.
- 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.
- Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.
- Production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related to metabolite, Liver enzymes.
- Review of mortality cases, evaluation of CIOMS, production of queries to address information gaps in CIOMS of such deaths.
- Review of SUSARs and contact with PIs in each reported SUSAR to understand the case assessment. Production of initial narrative to understand each individual case.
- Collaboration in the presentation of safety aspects in the Medical Monitoring Meeting
- Collaboration in Safety Management Team
- 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.
- Requires an MD or PharmD degree, board certified/eligible and/or specialization in Dermatology is a plus.
- A minimum of 5+ years of clinical development experience in the pharmaceutical/biotech Industry.
- Previous experience conducting clinical trials in Dermatology is a plus
- Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.
- Must have a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies.
- 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.
- Flexible approach to where and how we work
- Competitive compensation package including bonus.
- Stock options and RSU awards
- Employee stock purchase plan
- 401(k) plan with company match
- Professional Judgment Vacation Policy
- 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).
- Medical, dental, and vision plans
- Company-provided short- and long-term disability plans
- Company-provided life insurance
- Unique offerings of pet, legal, and supplemental life insurance
- Flexible spending accounts for medical and dependent care
- Accident and Hospital Indemnity plans
- Supplemental AD&D
- Employee Assistance Program (EAP)
- Mental Health on-line digital resource
- On-site, no-cost fitness center at our U.S. headquarters
- Paid time off to volunteer
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Director Clinical Development - Bridgewater, United States - Insmed, Inc.
Description
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases.
We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves.
If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
RecognitionsNamed Science's Top Employer in 2021, 2022, and 2023
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No.
1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.
A Certified Great Place to WorkWe believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row.
We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, and Best Workplaces for Millennials lists.
Overview
The Director, Clinical Development will play an important role in working with the team to execute the global clinical development plans of brensocatib for the HSindication.
protocol, study report, 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. This opportunity will require a focus on all the clinical aspects of the upcoming HS program. Strong leadership skills are a must for this highly visible opportunity. This position will require working in a fast-paced, high energy, entrepreneurial environment.Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:
Up to 25% travel based on vendor requirements
Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
Compensation & Benefits
We're committed to investing in every team member's total well-being, now and in the future.
We offer a competitive total-rewards package to all employees around the world, including:
ADDITIONAL U
S BENEFITS:
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by 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.
Applications are accepted until the position is filled.
