-
Clinical Trial Manager
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
-
Manager of Clinical Trial Supplies
1 week ago
Whitridge Associates Cambridge, United StatesResponsibilities: · Develop clinical supply strategy in conjunction with Clinical Team · Work with the Clinical and Regulatory Teams to ensure that the label texts for each territory involved in a clinical trial meet requirements · Work with the Clinical and CMC Teams to ensure t ...
-
Sr. Clinical Trial Manager
2 weeks ago
BioSpace Cambridge, United StatesJob Details · The Role · The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing.Strong vendor management is ...
-
Senior Clinical Trials Manager
2 weeks ago
Clinical Dynamix, Inc. Cambridge, United StatesRole: Clinical Trial Manager / Senior Clinical Trial Manager · We are looking for a energetic and passionate Clinical Trial Manager / Senior Clinical Trial Manager who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a ...
-
Sr. Clinical Trial Manager
2 weeks ago
Moderna Theraputics Cambridge, United StatesThe Role · The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing.Strong vendor management is critical for ...
-
Senior Clinical Trial Manager
3 weeks ago
Boston Pharmaceuticals Cambridge, United StatesCompany 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 ...
-
Associate Director, Clinical Trial Manager
2 weeks ago
BlueRock Therapeutics Cambridge, United StatesWho is BlueRock? · BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generati ...
-
Associate Director, Clinical Trial Manager
2 weeks ago
BlueRock Therapeutics Cambridge, United StatesWho is BlueRock?BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation o ...
-
Clinical Trial Manager
4 weeks ago
Beacon Hill Boston, United StatesPosition Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and ...
-
Sr. Manager, Clinical Trial Transparency
2 weeks ago
Moderna Theraputics Cambridge, United StatesThe Role: · The Senior Manager of Clinical Trial Transparency & Disclosure is a high-impact role, reporting directly to the Director of CTTD. The chosen individual will not just be responsible for, but will excel in delivering high-quality clinical and regulatory writing, from th ...
-
Clinical Trial Manager
2 weeks ago
Dragonfly Therapeutics Waltham, United StatesClinical Trial Manager · Dragonfly Therapeutics seeks a Clinical Trial Manager with relevant Clinical Operations experience to join our Clinical Development group and who will be responsible for providing trial management support for our cancer immunotherapy programs. This role ...
-
Sr./Clinical Trial Manager
3 weeks ago
Apex Systems Watertown, United StatesSr. Clinical Trial Manager · Location: Waltham, MA (Hybrid) · Therapeutic Area: Auto Immune · Job Overview:We are looking for a talented and curious professional to oversee study activities, manage relationships with study sites and vendors, and identify project risks and cont ...
-
Clinical Trial Manager
2 weeks ago
Staffmark Group Waltham, United StatesGreat long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting ...
-
TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Opera ...
-
Clinical Trial Manager
4 weeks ago
BioSpace Waltham, United StatesJob Details · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associate Director, Clinical Operati ...
-
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the executi ...
-
TScan Therapeutics Waltham, United StatesJob Description · Job DescriptionPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Manager to join our Clinical Operati ...
-
Viridian Therapeutics Inc. Waltham, United States· At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driv ...
-
Clinical Trial Manager
3 weeks ago
Visterra Waltham, United StatesJob Description · Job DescriptionSalary: · Summary · Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team. The CTM is a key member of the Clinical Operations team and supports the execution and management of clinical trial(s). The CTM reports to the Associ ...
-
Clinical Trial Manager
1 week ago
Entrada Therapeutics Boston, United States Full timeThe Organization · What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. · O ...
Senior Clinical Trial Manager/Clinical Trial Manager - Cambridge, United States - Fusion Pharmaceuticals LLC
Description
Fusion Pharmaceuticals (
NASDAQ:
FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.
Fusion's clinical portfolio includes:
FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial.
In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immune-oncology agents.
Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R.
To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.
Apply below after reading through all the details and supporting information regarding this job opportunity.Responsibilities:
Work closely with Clinical Operations and Development Team in generating and overseeing study plan(s)Leads and manages internal and external clinical operation activities for complex clinical study(ies).
Oversees daily activities and deliverable of CROContributes significantly to relevant study documentation including project plans; implements and monitors progress against project plans and revises as necessaryReviews and authors applicable sections of clinical protocols, CRFs, study reports, IB and informed consent forms Proactively identifies project risks and develops resolution plansParticipates in the selection of Investigators and vendorsParticipates in study data review and assists with site management to ensure data quality/timely data entryResponsible for managing approved study budget(s) against trial progress and bring deviations to department leads.
Review and approve Vendor invoices, including investigator grants and pass through costs.Assists with the negotiation & establishment of contracts and budgets with external clinical sites and vendorsCollaborate with CMC and clinical supply colleagues to properly project for drug supply needsTrack record of strong study management showing clear proficiency in clinical project management skillsSolid vendor management skillsBroad understanding of operations including those in related development functionsDemonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug developmentDemonstrates ability to effectively interface with key medical personnel at clinical site(s)Demonstrates ability to lead multi-disciplinary teamsDemonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of dataMaintains a flexible, can-do approach to address issues proactively and innovativelyPossesses excellent written and oral communication skills
Qualifications
B.S.
degree or equivalent, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)Minimum of 3-5 years for a CTM and 5-8 years for a Senior CTM of clinical trial management experience in the pharmaceutical, biotech and/or CRO industryOncology therapeutic area experience is required for this position.
Phase 1 and/or 2 experience preferableWorking knowledge of ICH Good Clinical Practice guidelinesRequires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors Experience and ability to manage global or regional teams in a virtual environmentProven track record in successfully managing trials from start-up to database lock Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issuesMust be adaptable and enjoy working in a fast-paced environmentEffective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverablesWillingness to travel up to 10-20% of time
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.
PDN-9bdf85a ba-9bdf-2a79adb4ccdf