Clinical Scientist

Actinium Pharmaceuticals, Inc.; New York (NY); On-site; USD 177,000 - 251,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Disability insurance

Job summary

Actinium Pharmaceuticals, a leader in targeted radiotherapies, seeks a Head of Human Resources to lead clinical strategy development and oversee trials. The ideal candidate will have significant experience in clinical research and a strong background in oncology and drug development.

Qualifications

• 7-10 years clinical, scientific/research experience in biotechnology/pharmaceuticals.
• Experience with early-stage clinical drug development through regulatory submissions.
• Oncology experience preferred.

Responsibilities

• Designing and implementing clinical strategies for assigned modalities.
• Accountable for the conduct of clinical studies and oversight of trial activities.
• Providing expertise to cross-functional teams and engaging with external stakeholders.

Skills

Collaboration

Interpersonal Communication

Strategic Planning

Education

Ph.D. or PharmD degree

Relevant Master’s degree

Tools

MS Office Suite

Job description

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Head of Human Resources at Actinium Pharmaceuticals

Actinium Pharmaceuticals is a pioneer in the development of targeted radiotherapies intended to meaningfully improve outcomes for patients with advanced cancers including relapsed or refractory disease who have failed existing therapies. We are advancing a pipeline of differentiated clinical stage product candidates focused on validated cancer targets.

Our current pipeline is focused on indications in myeloid malignancies, solid tumors and conditioning for cell and gene therapies that we believe have high unmet needs that are not addressed by currently available treatment options. We are advancing two clinical stage product candidates that are directed against validated cancer targets. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Ac-225. We are also evaluating Actimab-A’s potential to synergize with PD-1 immune checkpoint inhibitors in solid tumor indications. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. ATNM-400 is Actinium's novel non-PSMA targeting Ac-225 radiotherapy for prostate cancer, which is supported by preclinical data and is being advanced to clinical trials. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications.

Our goal is to create a specialty radiopharmaceutical company with capabilities across radioisotope production, final drug product manufacturing, preclinical R&D and clinical development. We are deploying our technologies and capabilities, which we believe to be industry-leading, and intellectual property with approximately 230 issued and pending patents worldwide, to develop targeted and next-generation radiotherapies.

Purpose and Scope:

The primary purpose of the Clinical Scientist will be to participate in the development of clinical strategies for assigned modalities or indications. This position is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Clinical Scientists are expected to perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.

• Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs.
• Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
• Serves on the clinical sub-team and supports preparation of clinical development plans, site identification and management.
• Under the guidance of study physician/med lead, perform medical monitoring activities (Review, analyze and triage patient data, generating reports
• Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
• Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
• Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Early and/or late phase studies
• Exhibits expertise related to Study Data Review and Analysis:
• Provides clinical input into statistical planning, data analysis and interpretation
• Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications
• Works closely with operations group for site and vendor feasibility, trial set up and monitoring.
• May lead the execution of contracts, particularly for investigator meetings and advisories.
• Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
• May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition.
• Performs other duties as assigned or special projects as needed.

Qualifications:

Required:

• Ph.D. or PharmD degree, or other relevant Master’s degree. Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-10 years clinical, scientific/research, pathology or industry related experience or combination of academia and industry.
• Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
• Oncology experience a must. Solid tumor preferred.
• Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
• Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software.
• Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV).
• Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
• Knowledge of global pharmacovigilance standards and guidance documents.
• Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
• Excellent strategic planning, organizational and verbal and written communication skills.
• Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions. Highest level of scientific integrity.
• Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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