Senior/ Executive Director Clinical Operations

Company:

Actinium Pharmaceuticals, Inc. develops Antibody Radiation Conjugates, or ARCs, and targeted radiotherapies intended to meaningfully improve survival for patients with relapsed or refractory cancer who have failed existing therapies. We are deploying our technology platform, which we believe to be industry-leading, and intellectual property with over 235 issued and pending patents worldwide, to develop ARCS and next-generation radiotherapies against validated cancer targets. Actinium’s strategy is to build an integrated, specialty radiotherapeutics company using the power of our platform to deliver new treatment options for patient populations living with high unmet medical needs in hematology and oncology.

Our product candidates, Iomab-B and Actimab-A, have the potential to improve outcomes for patients with relapsed or refractory acute myeloid leukemia (r/r AML) and address the significant unmet need for better outcomes from treatment with therapeutics or from undergoing a bone marrow transplant. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium plans to advance with a potential strategic partner in the U.S. following completion of FDA interactions. Actimab-A is a targeted therapy that has demonstrated the potential to extend survival outcomes for people with r/r AML and is poised for advanced development in collaboration with the National Cancer Institute. We are also developing our Iomab-ACT program, a next generation conditioning program for rapidly growing cell and gene therapies, with FDA clearance of an IND to study Iomab-ACT as targeted conditioning prior to commercial CAR-T therapy and an IND for an investigator-led clinical trial for Iomab-ACT prior to a bone marrow transplant for patients with sickle cell disease.

Our R&D capabilities have the potential to yield differentiated, high-value ARC programs that demonstrate our experience across multiple validated cancer targets and isotopes and cover broad areas of focus leveraging our clinical development experience across hematology, targeted conditioning, solid tumors, and next generation ARCs.

Job Overview:

The incoming SD/ED of Clinical Operations, reporting to the SVP Clinical Development, will be responsible for developing and implementing clinical operation strategies to successfully execute and enhance Actinium Pharmaceuticals Inc. clinical research pipeline. This role will provide effective leadership, and oversight of clinical studies. The successful candidate will independently oversee the conduct of oncology clinical trials, including management of CROs and vendors.

He/She will perform assigned responsibilities to ensure project deliverables are met in accordance with the departmental goals and objectives and will assist with special projects as assigned, including additional clinical trials.

Key Responsibilities:

Provides operational expertise and strategic input to the advancement of clinical development plans by supporting the clinical strategy for clinical programs

Oversees clinical trial site identification and selection, clinical trial patient database designs and clinical files

Enables patient recruitment, institutional relationships, data management and safety monitoring

Manages progress of clinical studies and ensures adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and reviewing and acting on trending reports

Responsible for clinical operations protocols and the review, interpretation, and communication of progress, and emerging data of ongoing research projects within and outside the organization

Implements processes and build a clinical operations organization to successfully plan and conduct multiple clinical trials in early to late stage to achieve pipeline objectives

Provides oversight of IST programs

Works closely with Regulatory to assist with preparation and review of documents/ correspondence for regulatory agencies

Manages regulatory submissions, including IND applications

Ensures operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials

Leads clinical operations activities to translate strategic decisions into actionable operational plans

Oversees the negotiation of clinical study budgets, including investigator fees and vendors, timelines and project plans

Provides direct hands-on management and oversight of CROs and other vendors

Responsible for the co-monitoring activities associated with the assigned clinical studies, and/or clinical monitoring activities delegated to CROs

Prepares and distributes status reports, monthly management reports, ad hoc reports, summaries, or analyses as required for assigned clinical studies

Participates in the periodic review and revision of departmental policies and SOPs to assure compliance with corporate policies and Good Clinical Practice procedures (GCPs)

Maintains knowledge of U.S. and foreign regulations, guidelines, policies, and practices for conducting global clinical investigations

Reviews and participates in finalizing and obtaining approval of final clinical study reports. Evaluates tables and listings to support final clinical study report

Qualifications:

Medical/scientific degree (e.g., MS, PhD, PharmD) including nursing, public health, life sciences, pharmacy, or medicine, plus at least 7 years direct pharmaceutical industry experience specifically in drug development

Must have experience in Oncology/Solid Tumors, including Prostate Cancer

Must have experience in radiopharmaceuticals

Must have experience in IND/NDA submissions, BLA submissions, FDA regulations, and ICH/GCP guidelines

Previous experience managing CROs and other external vendors

Excellent verbal and written communication and presentation skills

Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team, provide mentorship to team members and to effectively manage multiple vendors. Ability to efficiently manage direct and indirect reports including remote staff.

Strong project management, presentation, organizational, and leadership skills

Results oriented. Demonstrates strong initiative, accountability, and willingness to take ownership and drive projects to completion.

Executive presence, with strong verbal and written communication skills across multiple levels of an organization, including senior leadership

Excellent organizational skills and an ability to prioritize effectively to deliver results within timelines

Must be a self-starter and have the ability to influence and lead a project through the various stages of drug development

Must be able to build relationships with the functional team members in order to ensure complete understanding of the overall project strategy and ensure operational excellence

Proven track record of delivering on-time, on-budget, and achieving results

Compensation will be commensurate with experience. Actinium offers competitive base salaries, performance bonuses, equity incentive plans, 401(K) with company matching and comprehensive health benefits.