CompanyActinium Pharmaceuticals, Inc.
is a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies for patients with high unmet needs.
Actinium’s vision is to build a fully integrated specialty oncology company built on our innovative R& D capabilities in targeted radiotherapy.
Our lead program, Iomab-B, completed patient enrollment of its pivotal Phase 3 trial and will report topline data in the second half of 2022, which is expected to support a BLA filing.
We are also advancing Actimab-A, a targeted radiotherapy being studied in multiple Phase 1/2 trials for patients with relapsed/refractory blood cancers.
Underpinning our clinical programs is our AWE technology platform that is supported by over 160 patents and extensive technical know-how.
Our AWE technology platform is being utilized in a research collaboration with Astellas Pharma focused on solid tumor theranostics, CD47 immunotherapy combinations with EpicentRx, Inc.
and HER3 solid tumors with AVEO Oncology.
Actinium strives to be the leader in the field of targeted radiotherapy and bring important medicines to patients.
We anticipate strong growth across our clinical pipeline based on our R& D efforts and are eager to fill this position of Junior Scientific and Business Analyst.Job OverviewThe primary responsibility of the Vice President of Clinical Development is to lead all aspects of the clinical development of one or more of Actinium’s assets in hematology, thus playing a leadership role in integrating Actinium medical activities.
This includes the planning and execution of clinical trials, Clinical Operations activities, and Clinical Research Organization (CRO) activities towards the goal of efficiently completing clinical trials and clinical development programs.Duties and ResponsibilitiesResponsible for the planning and execution of clinical studies in order to successfully move programs though the clinical research process in a timely manner, in adherence with Good Clinical Practice (GCP), appropriate Standard Operating Procedures (SOPs) and government regulations.
This position has the following primary responsibilities: Work closely with the CMO to carry out clinical research priorities of the companyAs Program Director for one or more clinical development programs, lead clinical development strategy in hematology as well as the execution of the clinical development plans Manage a clinical development team that will include other physicians and clinical operations staff, as appropriate for the development stage of the projectSupervise the writing and execution of clinical protocols and all supporting documents, including Informed Consent Forms (ICFs); Investigator Brochures (IBs); Imaging, Nursing, and Pharmacy Manuals; Data Monitoring Committee (DMC) and Endpoint Adjudication Committee (EAC) Charters; and all CRO-specific plans, and maintain these documents as needed due to protocol amendmentsOversee clinical trial site selection, CRF design, and other clinical trial activities.Perform clinical review of data listings and review essential study dataSupervise the negotiation of clinical budgets, including investigator fees and vendorsCreate and/or review clinical slides for internal and external meetingsPlan and lead investigator meetingsParticipate in Safety Advisory Boards and track or analyze any potential safety event within a given study and across studiesWork with Regulatory Affairs in drafting clinical sections of pre-FDA meeting packages and participate in FDA, or other health authority, meetings as neededLead cross-functional project team meetingsManage relationship with outside vendors, such as National Marrow Donor Program or specialty laboratoriesHire staff for clinical development and clinical operations positionsTravel to sites to develop relationships with key stakeholders, as well as travel to meet with key vendors QualificationsMinimum qualifications required to successfully perform the job are: MD degreeMinimum of 8-10 years of experience in clinical research requiredMinimum of 5 years’ oncology experience – strongly prefer clinical research experience be mostly in the field of solid tumorPrior pharmaceutical industry experience essentialExperience with radio-immunotherapy drugs is a plusStrong interpersonal and communication skillsStrong presentation skillsTraining in GCP and knowledge of the research process, of the importance of adherence to protocols, and of the accuracy needed in collection and documentation of research dataMust have the ability to obtain and interpret clinical data as it relates to the diagnosis and treatment of research subjects in company clinical trialsAdherence to the highest ethical standards Compensation will be commensurate with experience.
Full-time, salaried position with full benefits including 401K matching