Insmed Incorporated

Director Clinical Development

Job Post Information* : Posted Date 5 days ago(5/15/2024 3:40 AM)
External ID
2023-5259
Number of Positions
1
Remote
No
Position Location (WD) : Location
JP-JPN-13-Tokyo

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. 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.

Recognitions

 

Top-Employer-2023-Colors-221x300

Named 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.

  

 

Insmed_2023_Certification_Badge2

 

A Certified Great Place to Work

We 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.

  

 

Summary

This position is accountable for scientific discussion/deliverables, especially in case of the necessity of some clinical data, study design and outlines, study results and clinical data package in clinical studies (included company-initiated studies (CIS) and Post Marketing Surveillance (PMS)) in the assigned projects, from early to post-marketing. This position is responsible to discuss the clinical data package and/or the necessity of clinical data, to execute designing, implementation and completion of clinical studies fulfilling clinical data package for appropriate submission and also to execute appropriate communication with Pharmaceuticals and Medical Devices Agency (PMDA) about clinical studies; e.g. PMDA consultation, submission, etc. Also responsible for the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Sub-team.

Responsibilities

Responsibilities will include, but are not limited to, the following:

  • Contribute to the strategic development of early and late stage clinical programs and provide medical expertise where needed (which may include assisting colleagues in Pharmacovigilance).
  • Provide program level medical oversight of information included in regulatory documents including clinical sections of CTN submissions, CTN/DSUR Updates, Investigator Brochures and IMPD's Draft, briefing books, clinical sections for the J-NDA/J-CTD submissions, Statistical Analysis Plan (SAP), orphan drug designation, and responses to questions from regulatory authority or EC/IRBs.
  • Provides medical/scientific input and advice by working closely with 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.
  • Plan and Execute Clinical Studies in Japan.
  • Participates in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
  • Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments in compliance with Clinical Development Plans and regulatory requirements.
  • Reviews specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
  • Participates in investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
  • 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 process creation and SOP writing and updating as needed.
  • Collaborate with team members such as regulatory affairs, project management, clinical operation, medical affairs, Drug Safety Pharmacovigilance, medical information, clinical QA, etc. to proceed with the projects.

Qualifications:Experience/Knowledge

  • At least 6 years of clinical development experience in the pharmaceutical/biotech Industry including clinical study experience
  • Experience in Global, cross-functional team environment
  • Experience in respiratory, infectious disease, immunology area, and/or gene therapy area are preferred
  • Experience in the management across a development program and participation in J-NDA filing is preferred.
  • Basic knowledge of gene therapy area
  • Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies

Skills/Capabilities

  • Language proficiency:
    • Native-level fluency in Japanese language (reading, writing and conversation) is required.
    • High-level business fluency in English is required.
  • An uncompromising ethical standard and level of conduct are essential
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Must work well both independently and in teams, have excellent time management skills and be able to work well under pressure and work effectively across functions as a team player
  • Demonstrates influence, negotiation and conflict resolution skills, including the ability to influence with supports from his/her supervisor
  • Demonstrates mind set of problem solving skills for developing creative solutions
  • Must have excellent communication and presentation skills (verbal and written / Japanese and English) with the ability to effectively present ideas and influence others that achieve desired results
  • Demonstrated experience improving, developing and implementing new processes
  • Flexible, diplomatic and able to effectively deal with ambiguity
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Qualification/Certificate

  • Master’s degree in Life/Pharmaceutical Science, or equivalent is required

Others:

  • Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competencies
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
  • Non-smoker

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:

  • Flexible approach to where and how we work, regionally based
  • Competitive compensation package including bonus 
  • Stock options and RSU awards
  • Employee Stock Purchase Plan (ESPP)
  • Flexible Vacation Policy
  • Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

  • 401(k) plan with company match
  • Medical, dental, and vision plans
  • Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
  • Company-provided short and long-term disability benefits
  • Unique offerings of pet, legal, and supplemental life insurance
  • Flexible spending accounts for medical and dependent care
  • Accident and Hospital Indemnity insurance
  • Employee Assistance Program (EAP)
  • Mental Health on-line digital resource
  • Well-being reimbursement
  • Paid leave benefits for new parents
  • Paid time off to volunteer
  • On-site, no-cost fitness center at our U.S. headquarters

Additional Information

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 for 5 calendar days from the date posted or until the position is filled.

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