15 Clinical Development Director jobs in Murrysville

Job Details

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.

Requirements/Qualifications:

• 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-MM1
#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.

Job Title: Clinical Research Coordinator
Location: Pittsburgh, PA, Hybrid: Combination of On-Campus and Remote work as determined by the department.
Schedule: varied including evening, overnight, and weekend hours
Type: Direct Hire
Overview:
A top-ranked research university is currently searching for a Clinical Research Coordinator for one of its growing departments to be responsible for assisting in the operations of ongoing clinical trials. If interested in joining this dynamic department, please apply!
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.
+ 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 a year of direct clinical research/clinical trial experience is highly preferred
+ 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.
#M3
Ref: #558-Scientific
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Description:
Could you be our next Clinical Research Coordinator at Bryn Mawr Hospital?

Why work as a Clinical Research Coordinator with Main Line Health?

•Make an Impact! The Clinical Research Coordinator I will manage a variety of clinical research projects with oversight by senior staff and investigators, for the Oncology Clinical Research Program. The day-to-day assignments for executing clinical trials will include the execution of study procedures as outlined by the study protocol (and related documents), screening medical records for eligible research patients, scheduling appointments, collecting and entering data into trial systems in collaboration with junior staff, and collaborating with senior staff and investigators to manage source data and reporting requirements. The CRCI will require an impeccable attention to detail, sound judgment, and a high level of knowledge of protocol requirements and medical terminology. This role is Patient Facing, interacting with Oncology patients in the hospital and clinic setting. This individual will work under direct supervision and instruction

• Develop and Grow your Career! Invest in furthering your education through seeking certifications or advanced degrees by taking advantage of our Tuition Reimbursement! This position is eligible for up to $6,000 per year based upon your Full or Part Time status.
• Join the Team! Like our patients, the Main Line Health Family encompasses a wide range of backgrounds and abilities. Just as each of our patients requires a personalized care plan, each of our employees, physicians, and volunteers, bring distinctive talents to Main Line Health. Regardless of our unique design, we all share a purpose: providing superior service and care.
• Position-Specific Benefits include: You are eligible for up to 200 hours of paid time off per year based on your Full or Part Time status. We also offer a number of employee discounts to various activities, services, and vendors. And employee parking is always free!

Position: Clinical Research Coordinator
Shift: 8am-4:30p, Monday-Friday

Experience:

1-2 years clinical research experience. (Clinical research conducted while in the student environment may be considered on a case-by-case basis. Experience working in a healthcare setting preferred.

Education:
BA/BS required.

Licensures/Certifications:

Successful completion of CITI Program and IATA training required within 3 months of hire. ACRP research certification highly encouraged within 1 year of hire.

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.
#M3
Ref: #558-Scientific
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Start strong: Earn a $20,000 sign-on bonus when you join our team!
UPMC Presbyterian is hiring an MRI Clinical Research Specialist to join our team!
This full-time position follows a schedule of four 10-hour shifts (7:00 AM - 5:30 PM), including rotating weekends and holidays. One day per week will be spent at the MRI Research Center.
This is an exciting opportunity for MRI professionals looking to grow their careers in both clinical and research settings. As an MRI Clinical Research Specialist, you'll support ongoing clinical research efforts under the guidance of the MR Clinical Specialist and collaborate with both clinical and research MRI departments.
Experience with GE and Siemens MRI scanners is highly preferred.
Join us in advancing imaging science while making a difference in patient care!
**Responsibilities:**
+ Oversee and coordinate all clinical research QA and required documentation for multiple modalities (MR, US, CT, etc).
+ Establish and maintain all protocols associated with the clinical research.
+ Secure images and image transfer with appropriate de-identifiers.
+ Shall maintain shared work effort in both clinical MR and research MR and will be required to work a minimum of 1 research shift per week in the MRRC.
+ Explain procedures and answer patients' questions and concerns before performing the procedure.
+ Position patients choose appropriate factors and follow established protocols required to produce high quality MR scans.
+ Complete requisition and charge vouchers according to department procedures.
+ Promptly responds to medical editing requests.
+ Film MR exams as described in the protocol guidelines.
+ Maintain working knowledge of all scan equipment e.g. coils, upgrade, etc.
+ Perform image post processing, networking and archiving as needed.
+ Perform patient assessments as needed.
+ Perform venipuncture and administer MR contrast as ordered by the radiologists.
+ Maintain working knowledge of scanning equipment and perform minor calibrations on the equipment and/or report the need for major services or repairs to proper personnel.
+ Operate and maintain monitoring equipment. Demonstrates complete operation of specialty equipment, analyzes data promptly, and completes quality control activities.
+ Available for duty according to department guidelines for unscheduled absences, punctuality and manpower requirements.
+ Participate in the Patient Safety Program and the quality improvement program of the department and hospital activities.
+ Patient safety is addressed through marking sides on films, marking side site, and proper identification of patients. Seek increased responsibilities.
+ Performs or assists MR physicists with performing QA, regulatory testing, and other technical and research initiatives.
+ Participate in Research Presentations.
+ Participates in standardization activities with system-level workgroups.
+ Works directly with MRRC Director and MR physicists on protocol development.
+ Assist with the onboarding and training of staff and students.
+ The MRI Clinical/Research Technologist, Specialist must have satisfactorily completed formal training in a radiology related program, i.e. Radiology or Nuclear Medicine with accreditation by the ARRT or ARMRIT or NMTCB.
+ Requires a minimum of 3 years of MRI experience in radiology and/or Nuclear Medicine.
+ Must have obtained a performance review rating of strong/solid/good on most recent performance review to be eligible for promotion. **Licensure, Certifications, and Clearances:**
+ ARRT Magnetic Resonance Imaging OR American Registry of Magnetic Resonance Imaging Technologist (ARMRIT)
+ Basic Life Support (BLS) OR Cardiopulmonary Resuscitation (CPR)
+ Act 34
**UPMC is an Equal Opportunity Employer/Disability/Veteran**

**About the Job**
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
The Senior Clinical Research Director (Sr CRD) is noted as the **primary clinical lead for programs** .
The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.
The role of the Senior CRD is to:
+ Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
+ Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams
+ Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
+ Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
+ Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
+ Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
+ Internal Governance: Preparation of Documents and Presentations for Internal Governance Meetings
+ Contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
+ Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications Take on as necessary the CRD role:
+ Review and/or contribute in the the clinical section of the Investigator's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
+ Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams
**Minimum Level of any Required Qualifications:**
+ Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written)
+ At least 4 years in pharmaceutical industry or CRO, previous experience in clinical development
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$225,000.00 - $375,000.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK ( .
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (