5 Clinical Development Director jobs in Langeloth
Senior Director, Clinical Development
Posted 7 days ago
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Job Description
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
Consistently Ranked Science 's Top Employer
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've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview
The role as a Clinical Indication Lead will be responsible for the clinical input into broader TPIP program strategy related to the pulmonary arterial hypertension indication in mid-to-late-stage development. In addition, this role will be responsible for developing clinical strategic direction of engagements with health authorities related to the registration program and anticipated filings in collaboration with the Clinical Program Lead for TPIP. The individual will articulate the clinical goals (based on the Global TPP), clinical and safety strategy, and the underlying science and clinical need to internal and external audiences with clarity and credibility.
Responsibilities
- Leads clinical development team responsible for mid-to-late-stage development of TPIP in the PAH indication.
- Leads the matrix Clinical Study Team (CST) to effectively make decisions and handle conflict and change.
- Responsible for maintaining a high degree of CST effectiveness through collaboration, influence, and, as necessary, coaching of cross-functional team members.
- Collaborates with the Clinical Program Lead (CPL) to represent to the matrix Global Asset Team to ensure clinical program is represented and integrated into Global plans across functions.
- Collaborates with the CPL to build strategic and coordinated clinical development plans which are aligned with business objectives (TPP) and are differentiated from competitor products.
- Responsible for all clinical aspects of the clinical indication strategy.
- Accountable for the delivery of projects, partnering with other global development and related functions.
- MD/DO equivalent with preference for Cardiology or Pulmonary formal training. Will consider industry experiences in Pulmonary or Cardiology in drug development.
- 6+ years in biotech or pharma with most in a global clinical development role OR equivalent research experience. Combination of drug/device experience is a plus.
- sNDA or sBLA experience or original NDA or BLA experience preferred. Experience with J-NDA is a plus.
- Prefer experience in FDA advisory committee, or CHMP Scientific Advisory Group, or CHMP Oral Explanation.
- Previous direct people management required.
- Experience working in matrix development teams, e.g. Global Study Teams, required.
#LI-Remote
Salary Range
$290,000 - $347,600 a year
Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:
- Flexible approach to how we work
- Health benefits and time-off plans
- Competitive compensation package, including bonus
- Equity Awards (Long-Term Incentives)
- Employee Stock Purchase Plan (ESPP)
For more information on U.S. benefits click here .
Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Clinical Research Coordinator
Posted 4 days ago
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Job Description
Equivalent relevant work experience may be substituted for degree requirement. This position is located at UPMC Childrens Hospital of Pittsburgh in Lawrenceville. PA Child Abuse History Clearance, PA State Police Criminal Record Check, and FBI Crimi Research Coordinator, Clinical Research, Clinical, Coordinator, Research, Healthcare, Education
Clinical Research Coordinator II
Posted 1 day ago
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Job Description
Conducts research assessments on study participants. Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Assists with training staff. Ensures adherence to protocols and corrects issues with data Research Coordinator, Clinical Research, Coordinator, Clinical, Research, Healthcare, Education
Clinical Research Coordinator III
Posted 6 days ago
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Job Description
Job Title: Clinical Research Coordinator III Location: Pittsburgh, PA, Hybrid: Combination of On-Campus or Remote determined by the department. Schedule: Varied based on participants schedule Type: Direct Hire or 6 -12 month Contract based on department needs Overview: A top-ranked research university is currently searching for a Clinical Research Coordinator III for one of its growing departments to be for all study-related activities including screening & consent and enrollments, data collection/entry, and compliance with the regulatory process. Responsibilities: Will work closely with the Principal Investigators (PIs), study staff and clinical staff. Responsibilities include but are not limited to screening patients to determine eligibility/verification of enrollments, facilitating study activities, coordinating/conducting informed consent discussions, assisting with consent issues, and monitoring patients for complications and outcomes. Conduct and is responsible for all study-related activities including screening & consent and enrollments, data collection/entry, and compliance with the regulatory process. Encouraged to prepare strategies to improve enrollment/retention. May need to maintain and order supplies as needed. Will Assess protocol feasibility and establish protocol-specific recruitment plans. May be required to train junior staff and oversee the work of others as directed. Will be required to communicate effectively with study participants and potential community recruits. Assists with and adheres to Institutional Review Board (IRB) renewal, modification, and approved protocols. Recruits research subjects and conducts interviews and research assessments. Requirements: Minimum Education Requirement: Bachelor's Degree Experience Requirement: At least 3-5 years of clinical trial/clinical research experience within industry/sponsor trials Education/Experience Substitution: A combination of relevant education and experience will be considered in place of the specified educational and/or experience requirements. Preferred Certification: CRC certification is preferred but not required. #M3Ref: #558-Scientific
Clinical Research Coordinator - Full Time - Day Shift - AGH
Posted 4 days ago
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Job Description
Company: Allegheny Health Network
General Overview: This job plans, coordinates, and manages the activities associated with the initiation and completion of clinical trials, sponsored by internal, industry, foundation, and/or federal funding sources. Maintains compliance with all regulatory bodies associated with human subject research.
Essential Responsibilities:
- Interfaces with clinical staff to identify patients eligible for clinical trials. Provides in-service education to the appropriate hospital personnel in the departments involved with the investigational study. (30%)
- Interfaces with patients and their families to provide education regarding investigational studies, and requirements of participation to assure that they are informed prior to obtaining written consent. Completes required follow-up and active patient monitoring per study protocol. (30%)
- Collects, maintains, and stores all relevant clinical data, case report forms, and regulatory binders in accordance with the study sponsor and all regulatory bodies. (15%)
- Plans, coordinates, and manages all activities pertinent to the specific clinical trials, ensuring patient safety, good clinical practices, and compliance with the protocol and regulatory agencies. (15%)
- Performs other duties as assigned or required. (10%)
Qualifications:
Minimum:
- Associate's degree, RN, or equivalent research experience.
- 1-3 years' related experience.
Preferred:
- Bachelor's Degree.
- Current research-related certification from accredited program such as The Association of Clinical Research Professional (ACRP), e.g. Certified Clinical Research Coordinator (CCRC), ACRP Certified Professional (ACRP-CP) or The Society of Clinical Research Associates (SOCRA), Certified Clinical Research Professionals (CCRP).
- Driver's license may be required depending on facility requirements.
Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.
Compliance Requirement: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.
As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy.
Furthermore, it is every employee's responsibility to comply with the company's Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.
Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law. We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below. For accommodation requests, please contact HR Services Online at
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