Vaccinex, Inc. is a biotechnology company engaged in the discovery and development of therapeutic monoclonal antibodies and other biologics to treat a variety of serious human diseases. Vaccinex is currently advancing several lead therapeutic monoclonal antibody drugs through non-clinical and clinical development, and continues to expand its pipeline of promising product candidates. Founded in 1997, the company has enjoyed significant and sustained funding, allowing it to build a strong research & development team. The company is proud of its progressive team culture, and offers an outstanding career development opportunity in a fast-paced, dynamic and professional work environment.
Description
The Director, Clinical Development is responsible for providing clinical direction, clinical operations management, and clinical safety review for the company’s ongoing clinical trials in oncology and multiple sclerosis, as well as providing advanced leadership in the clinical aspects of drug development and protocol design for these indications. This individual will provide clinical operations leadership, and, as a member of the company’s Core Development Team, will oversee and manage the clinical project management group, other clinical operations groups as appropriate, and external CRO’s engaged in clinical research of one or more of the company’s therapeutic product candidates.
Responsibilities
- Clinical Safety Data Review: Serve as the primary clinical safety data reviewer for existing clinical trials, interacting as necessary with clinical site principal investigators and consulting clinicians. For each patient enrolled, review screening, enrollment and clinical study information, including data regarding prior treatment regimens. Participate in scheduled cohort review and other clinical trial meetings with company development and regulatory personnel, clinical site principal investigators and staff, as well as with CRO clinical trial team members and drug safety monitors.
- Drug Development: Serve as primary clinical leader for each clinical project. Assist in determining the optimal pathways and strategies for advancing therapeutic product candidates through the clinical stages of development. Assist in the development of program timelines and monitor these plans for adherence to completion of development objectives. With other development staff, review clinical and other documents as necessary for IND submissions for ongoing clinical investigations and for new investigational agents. Assist in the preparation for FDA or EMA teleconferences and meetings, and participate in these discussions. Interact with company project management and functional development teams. Assist in the development and review of clinical development plans and target product profiles for each drug candidate in each indication.
- CRO Management: With the clinical project manager, guide interactions with and activities of clinical research and clinical laboratory organizations engaged in company clinical trial activities. Oversee review and management of specific study contracts and budgets, lead the review of statistical analysis plans and database construction and modification, and assist in the management of other CRO activities as appropriate. Work with clinical project manager and appropriate CRO and clinical site staff to develop and implement amendments to existing clinical protocols and other documents.
- Clinical Trial Start-up and Management: Work with consulting physicians to draft clinical protocol synopses. Work with other internal development staff to draft and finalize clinical study protocols, clinical site agreements and other relevant clinical documents. Oversee the recruitment and review of clinical sites and the compilation and distribution of study start-up packages. With clinical project manager lead clinical site start-up meetings with clinical site staff and CRO representatives, and participate in periodic audits of clinical site documentation. Participate in investigator’s meetings as well as internal and external educational seminars as needed. Identify, recruit and interact with external clinical indication experts and key opinion leaders.
- Clinical Trial Conduct: Together with the clinical project manager, oversee interactions with clinical research associates monitoring ongoing clinical studies; manage investigator recruitment efforts and resolve patient recruitment problems. Interact with clinical project management, study clinicians, CRO drug safety personnel and regulatory affairs team members regarding the preparation, review and submission of serious adverse event reports to FDA. Oversee management of clinical drug product inventories by development and CRO staff responsible for these activities.
- Clinical Trial Reporting: Assist in reviews of case report forms, data tables, figures, listings and other formal data analyses; assist in preparation of interim analyses and clinical study reports. Lead the preparation of various pertinent safety summaries for official documents (e.g. Investigator’s Brochure, annual reports); participate in the preparation and review of other sections of these and other regulatory documents containing pharmacology, bioanalytical and toxicology data, as needed.
Budgeting: Assist in preparation of justification for additional staff, consultants, vendors, etc. as needed. Assist in preparation of departmental budget requirements and short and long term budget projections for ongoing projects.
Qualifications
The position requires a U.S. MD/DO or PharmD with at least 3 years of experience, or a foreign medical degree with at least 5 years of experience, or a U.S. RPh/BSN/MSN degree with at least 8 years of experience. The required years of direct experience must consist of an in-depth background in clinical trial operations and in evaluating clinical safety data on behalf of a pharmaceutical or biopharmaceutical company sponsor (i.e. as an employee of or as a consultant to the sponsor company, or as an employee within a CRO providing direct services to the company sponsor). Appropriate professional board certification or licensure is required. Clinical development experience with biologics highly preferred. In-depth knowledge of general medicine, drug safety/pharmacovigilance practices and procedures, clinical pharmacology, clinical operations, clinical trial methodology, and drug regulatory principles and expectations is required. Experience interacting with oncology and/or neurology review divisions at FDA and/or experience with EMA regulatory review teams is also considered important. Strong interpersonal, organizational and oral and written communication skills are essential.
Please Note: Due to the high volume of responses, only inquiries from qualified candidates can be addressed.
Vaccinex, Inc. is an equal opportunity employer. No telephone inquiries or recruiters, please.