Associate Director, Clinical Operations
3 weeks ago
Job Description –
Associate Director, Clinical Operations
Position Summary
As an
Associate Director, Clinical Operations
at Harbinger Health, you will oversee the management of clinical trials from their inception to completion, expertly guiding both internal and external multidisciplinary teams. Reporting to the SVP of Clinical Operations you will drive trials forward, ensuring adherence to timelines and fostering collaboration across functions. Your leadership will be instrumental in liaising with CROs and vendors, providing oversight, managing compliance with study plans, and maintaining seamless execution, all within the framework of Harbinger Health's innovative clinical landscape.
Responsibilities:
Lead and represent the study team in designing, developing, and delivering clinical trials within established timelines.
Strategically plan and coordinate with cross-functional teams for optimal execution of clinical trials.
Act as the primary point of contact for CROs and vendors, providing critical oversight and management.
Maintain rigorous compliance with study plans, monitoring clinical studies through direct communication with CROs and investigator sites.
Assure compliance with internal SOPs, FDA regulations and GCP
Regularly update on clinical trial progress, managing budgets and timelines diligently.
Manage clinical data collection, clinical trial supply delivery, and Trial Master File oversight to ensure readiness for inspections.
Participate in document reviews, including protocols and clinical study reports, and contribute to RFPs and CRO/vendor selection processes.
Identify potential study issues, formulating proactive contingency plans.
Mentor team members and manage direct reports, fostering professional growth.
Perform additional duties as required by the evolving needs of the organization.
Basic Qualifications:
Bachelor's degree in health science or a related field.
6+ years of experience in clinical trial management.
Proficient communication, organizational, and problem-solving skills.
Advanced skills in Microsoft Office Suite and a keen eye for detail.
Demonstrated knowledge of ICH guidelines, GCP, and global regulatory requirements for clinical trials.
Proven ability to collaborate effectively both internally and externally.
Experience in facilitating project team meetings and ensuring stakeholder alignment.
Willingness to travel approximately 20%.
Preferred Qualifications:
Experience in Oncology, Diagnostics, and/or Liquid Biopsy.
#J-18808-Ljbffr
-
Associate Director, Clinical Operations
2 weeks ago
Cambridge, United States Clinical Dynamix, Inc. Full timeRole: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...
-
Cambridge, United States The Steely Group Full timeReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effectiv Clinical, Operations, Clinic, Clinical Research, Associate, Operation, Healthcare, Staffing
-
Director, Clinical Operations
2 weeks ago
Cambridge, United States Boston Pharmaceuticals Full timeCompany Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...
-
Director, Clinical Operations
2 weeks ago
Cambridge, United States Boston Pharmaceuticals Full timeCompany OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...
-
Director, Clinical Operations
2 weeks ago
Cambridge, United States Foghorn Therapeutics Inc. Full timeOur Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...
-
Associate Medical Director
2 weeks ago
Cambridge, United States The Steely Group Full timeThe Associate Medical Director is a medical doctor who provides medical and scientific leadership and oversees assigned clinical development programs and associated clinical trials. Responsibilities: Serves as a cross-functional medical lead on clini Medical Director, Associate, Director, Medical, Clinical Research, Operations, Healthcare, Staffing
-
Cambridge, United States The Steely Group Full timeReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in accordance with study...
-
Associate Director, Clinical Sciences
7 days ago
Cambridge, United States BlueRock Therapeutics Full timeThe Associate Director, Clinical Sciences, Ophthalmology will be charged with providing medical and scientific support for BlueRock's Ophthalmology programs. Reporting to the Senior Director, Clinical Development, Ophthalmology, this role will work closely with clinical and program leads as well as other subject matter experts to expand and execute on the...
-
Clinical Director
3 weeks ago
Cambridge, United States Empowered Staffing Full timeJob Description Job Description Empowered Staffing is partnered with Avenues Recovery Center, a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient...
-
Clinical Director
4 weeks ago
Cambridge, United States Empowered Staffing Full timeJob DescriptionJob DescriptionEmpowered Staffing is partnered with Avenues Recovery Center, a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient...
-
Associate Director, People Operations
5 days ago
Cambridge, United States Obsidian Therapeutics Full timeAssociate Director, People Operations Cambridge, MA About Us… Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE® platform technology to...
-
Associate Director, People Operations
4 days ago
Cambridge, United States BioSpace Full timeJob DetailsAssociate Director, People Operations Cambridge, MA About Us... Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian's programs apply our cytoDRiVE® platform...
-
Associate Director, People Operations
3 days ago
Cambridge, United States Obsidian Therapeutics Full timeAssociate Director, People Operations Cambridge, MA About Us… Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE® platform technology to...
-
Director, Clinical Supply Chain
5 days ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...
-
Director, Clinical Supply Chain
3 days ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...
-
Director, Clinical Supply Chain
4 weeks ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...
-
Director, Clinical Supply Chain
3 weeks ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...
-
Cambridge, United States Agios Pharmaceuticals Full timeAssociate Director, Scientific Communications and Publications Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selv Communications, Director, Associate, Communication, Internal, Clinical, Business Services
-
Director of Business Operations
4 weeks ago
Cambridge, United States Harvard University Full timeELSCE Administration: Responsible for running the day-to-day and other routine administrative operations (e.g. Staff Mtg, Anchor Day, Staff Retreat, etc.) of ELSCE; attend appropriate meetings (trainings, Admin Town Hall, SSAL Plus meetings, etc.) to stay informed and share information when relevant with Center colleagues. ELSCE Community & Culture:...
-
Cambridge, United States MOMA Therapeutics Full timeMOMA Therapeutics is looking for an experienced Associate Director/Director, CMC Program LeadershipImagine joining a company where you.... Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates Will work with incredible humans who are committed to the discovery of transformative...
