- Lead clinical development strategy in solid tumors, working closely with the Leadership/Management team to run all our solid tumor programs and in collaboration with Search and Eval, BD and R&D teams for assessment of solid tumor assets.
- As Program Director for one or more clinical development programs, lead clinical development strategy in solid tumors as well as the execution of the clinical development plans.
- Identify near and long-term clinical opportunities for the assets under preclinical development and formulate a strategy for IND, taking into consideration the MOA, probable patient populations and regulatory requirements.
- Manage a clinical development team that will include other physicians and clinical operations staff, as appropriate for the development stage of the project.
- Support Business Development activities, providing scientific and clinical input into discussions with potential partners.
- Work closely with R&D to develop and execute strategy to advance assets from early discovery through early clinical development.
- Supervise 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 amendments
- Oversee clinical trial site selection, CRF design, and other clinical trial activities.
- Perform clinical review of data listings and review essential study data.
- Supervise the negotiation of clinical budgets, including investigator fees and vendors.
- Create and/or review clinical slides for internal and external meetings.
- Identify and manage the external KOL team in solid tumor.
- Plan and lead investigator meetings.
- Participate in Safety Advisory Boards and track or analyze any potential safety event within a given study and across studies.
- Work with Regulatory Affairs in drafting clinical sections of pre-FDA meeting packages, IND applications and participate in FDA, or other health authority, meetings as needed.
- Lead cross-functional project team meetings.
- Manage relationship with outside vendors.
- Hire staff for clinical development and clinical operations positions.
- Travel to sites to develop relationships with key stakeholders, and travel to meet with key vendors
- Hybrid work schedule: 2-3 days in office are required.
- MD degree
- 10+ years of experience in clinical research required
- Minimum of 5 years of oncology experience – strongly prefer clinical research experience be mostly in the field of oncology
- Experience with mAb drug development and/or radio-immunotherapy drugs
- Strong interpersonal and communication skills
- Strong presentation skills
- Training 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 data
- Must have the ability to obtain and interpret clinical data as it relates to the diagnosis and treatment of research subjects in company clinical trials
- Adherence to the highest ethical standards
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VP, Clinical Development - New York, United States - Scismic Inc
Description
Job Description
Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.
Their vision is to build a specialty, hospital-focused radiotherapeutics company that develops and markets medicines for relapsed or refractory cancer patients who are treated primarily in large quaternary care hospitals and their catchment areas. On the basis of results that demonstrate meaningful survival benefit and provide the opportunity to move the goal post in AML, the company intends to launch two drugs in five years.
The company is well-funded. Their differentiated product pipeline is further exemplified by their next-generation program for rapidly growing cell and gene therapies, as well as their solid tumor and immunotherapy collaborations with several large companies. In addition, they have several other programs in solid tumors at the pre-clinical stage with IND-enabling studies ongoing and their extensive intellectual property portfolio includes over 200 issued patents and pending patent applications worldwide.
Job Overview:
The primary responsibility of the Vice President of Clinical Development is to lead all aspects of the development of one or more of the company's assets in solid tumors, by leading initiatives in building perspectives around strategic areas of interest—including new oncology targets, new therapeutic modalities, novel platform technologies and key strategic partnerships—that will enable the company to grow its industry leading pipeline and advance transformative medicines in solid tumors. This role is responsible for integrating and aligning anti-tumor strategies and leading key planning and execution of clinical development programs. The Vice President of Clinical Development will establish and maintain relationships with key stakeholders including the Clinical Operations team, Clinical Research Organization (CRO), R&D team and external key opinion leaders (KOLs) to efficiently run our clinical trials and execute our clinical development strategy.
This role reports to the Chief Medical Officer (CMO), with a dotted line to the Chief Executive Officer (CEO).
Key Responsibilities:
Responsible for the planning and execution of clinical studies 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:
Qualifications:
Minimum qualifications required to successfully perform the job are:
Compensation will be commensurate with experience. The company offers competitive base salaries, performance bonuses, equity incentive plans, 401(K) with company matching and comprehensive health benefits.
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