Vp Of Clinical Development
Aveta Biomics, Inc
Remote/Flexible | Bedford, MA
The successful candidate will be responsible for the medical aspects of development activities, including clinical development plans (CDP) and clinical trials. He/she will lead the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs; participate in and lead cross-functional teams and external vendors to generate, deliver, and disseminate clinical data supporting overall scientific and business strategy.
The initial focus of this position is to advance the clinical development of our Phase 2 ready asset for the treatment of Head and Neck Cancer and Phase 1/2 development of our drug for Glioblastoma. Additional activities will include advancing novel drugs for other non-cancer indication which are in advanced pre-clinical stage.
- Lead the design and implementation of a clinical development program(s) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and business needs.
- Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the clinical development plan.
- Oversee project-related education of investigators, study site personnel, and study staff
- Lead clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of data pertaining to safety and efficacy of the drug.
- Present at scientific, medical and regulatory meetings globally
- Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, and KOL’s.
- Contribute to activities in support of the company’s planned FDA submissions. Author clinical sections for INDs and other related documents
- Maintain a high level of clinical and scientific expertise in oncology and infectious disease area(s) by reviewing the literature, and attending medical/scientific meetings.
- Medical Doctor (M.D.) with clinical development experience is preferred
- Ph.D. with requisite clinical development experience will also be considered
- Experience in oncology and/or infectious diseases is desirable but not absolutely essential.
- A minimum of five (5) years of progressive responsibilities in drug development and a proven track record for clinical and scientific leadership in drug development is required.
- Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the development of clinical strategy and the design of study protocols
- Demonstrated leadership in running a complex clinical research program and ability to bring out the best in others on a cross-functional global team
- Ability to interact externally and internally to support a global scientific and business strategy
- Excellent communication and presentation skills are essential
Full-time preferred. Part-time negotiable for the right candidate
About Aveta Biomics
Aveta Biomics, Inc. is a Bedford, MA-based, clinical-stage company developing first-in-class combination therapeutics based on the knowledge of systems biology and network pharmacology. Our drug for Head and Neck Cancer is entering Phase 2 and the drug for Glioblastoma is entering Phase 1. The company has active collaborations with major academic centers in the USA and anticipates significant growth in activities in coming months.