The company applies deep expertise in formulation science and inhalation‑device engineering to ... MannKind's core technologies, including ultrafine dry‑powder formulations and advanced inhalation ...
The company applies deep expertise in formulation science and inhalation‑device engineering to ... MannKind's core technologies, including ultrafine dry‑powder formulations and advanced inhalation ...
Redding, CA For general information about the application process and temporary fire positions with ... Risks include smoke inhalation, fire entrapment, snake or insect bites and stings, exposure to ...
Redding, CA For general information about the application process and temporary fire positions with ... Risks include smoke inhalation, fire entrapment, snake or insect bites and stings, exposure to ...
Redding, CA For general information about the application process and temporary fire positions with ... Risks include smoke inhalation, fire entrapment, snake or insect bites and stings, exposure to ...
Redding, CA For general information about the application process and temporary fire positions with ... Risks include smoke inhalation, fire entrapment, snake or insect bites and stings, exposure to ...
Home Care RN
Morristown, NJ · On-site
$54 - $56/hr
... (2) administer inhalation therapy, (3) perform phlebotomy for outpatient lab testing, and (4) ... Bachelors of Science in Nursing - Preferred Schedule Notes: * Morris county * 40 hour work week ...
Quick apply
Apply Early
Home Care RN
Morristown, NJ · On-site
$54 - $56/hr
... (2) administer inhalation therapy, (3) perform phlebotomy for outpatient lab testing, and (4) ... Bachelors of Science in Nursing - Preferred Schedule Notes: * Morris county * 40 hour work week ...
Apply Early
Home Care RN
Morristown, NJ · On-site
$54 - $56/hr
... (2) administer inhalation therapy, (3) perform phlebotomy for outpatient lab testing, and (4) ... Bachelors of Science in Nursing - Preferred * Homecare Homebase Software Experience - Required
Quick apply
Apply Early
Home Care RN
Morristown, NJ · On-site
$54 - $56/hr
... (2) administer inhalation therapy, (3) perform phlebotomy for outpatient lab testing, and (4) ... Bachelors of Science in Nursing - Preferred * Homecare Homebase Software Experience - Required
Apply Early
Temporary Inhalation Scientist information
Associate Director, Trial Lead Clinical Operations (Contract to Perm)
Danbury, CT
$148K - $222K/yr
Full-time
Posted 18 days ago
Key responsibilities
Leads and manages all aspects of global clinical study progress, including protocol design, development, planning, initiation, execution, and close-out.
Coordinates study execution in collaboration with internal teams, CROs, contractors, and external vendors to ensure adherence to timelines, quality standards, and regulatory guidelines.
Tracks clinical study metrics, communicates trial status, and ensures cross-functional alignment on expectations, priorities, and deliverables.
Job description
MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
- Drives global Clinical Trial activities pertaining to study-level strategy, timelines, quality and execution of clinical studies
- Proactively identifies, problem solves and manages risks to trial execution and quality, implements corrective actions, and ensures inspection readiness at all times
- Supports the development of clinical study protocols and reports, ensuring studies are conducted in accordance with accepted scientific standards, meet relevant regulatory requirements and are conducted within ethical guidelines
- Drives development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc.
- Ensure adherence to FDA and GCP guidelines as well as other appropriate regulatory bodies as required
- Coordinates the development and distribution of critical study documents (ICFs, operational/training documents, reference documents, newsletters, site materials, etc.) and manages the TMF, as needed
- Drives study start-up, subject enrollment plan, clinical monitoring activities, clinical site compliance and data metrics from CROs and/or investigators, central labs, and other external vendors as required
- Communicates trial status by tracking clinical study metrics to ensure cross-functional alignment on expectations, priorities, and deliverables
- Represents MannKind, from a clinical perspective, building strong relationships with clinical trial sites including investigators and study staff
- Plans, facilitates, and monitors training at investigator meetings, kick-off meetings, and various CRO/vendor meetings
- Demonstrates budget accountability by tracking vendor performance against SOW, contracts and invoices to ensure consistency between work performed and contractual agreements
- Partners with Supply Chain to provide oversight and accountability of the applicable study drug(s), including supply projections, distribution, labeling and destruction
- Collaborates in the program-level development of clinical strategies, goal-setting, and establishment of timelines
- BS/BA +12 / MS/MBA 8-10, PhD 5+
- 5+ years direct clinical trial global experience (phase 2-3 preferred)
- Equivalent combination of education and applicable job experience may be considered
- Relevant industry (biotech or pharmaceutical) experience
- Knowledge of pulmonary orphan diseases and associated medical terminology
- Knowledge of Good Clinical Practices (GCP) and associated FDA regulations governing human subject protection and the conduct of clinical trial (IRB, IND, etc.)
- Proven experience in the oversight of the operational aspects of clinical studies, preferably in a global environment
- Exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation
- Ability to organize and manage multiple priorities
- Excellent oral and written communication skills
- Solution-focused, comfortable with ambiguity, and an organized self-starter
- Strong attention to detail in a fast-paced, evolving environment
- Works effectively in both individual and team-based settings, with a high sense of urgency
- Strong interpersonal skills and ability to build relationships with stakeholders at all levels
- Willingness to travel up to 25% of the time
About MannKind
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Danbury, CT, US
Year founded
1991