Vice President, Clinical Development - Immunology

Aditum Bio•Cambridge, MA

108d•$395,000 - $440,000

About The Position

At Aditum Bio our mission is to provide access to medicines to patients in need. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies and advances them into Phase 1 and Phase 2 clinical studies to enable proof of concept. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need. Position Summary Aditum Bio is seeking a Vice President, Clinical Development - Immunology, with a career focus in clinical development who will support the overall execution of designated Portfolio Companies’ clinical trials. This includes partnering closely with internal medical and clinical operations teams, as well as with key external partners such as CROs, investigators and consultants. The ideal candidate has a demonstrated command of early phase drug development and a track record of working successfully with highly matrixed cross functional teams.

Requirements

MD or MD/PhD with a minimum of 6 years of industry experience in clinical development in a pharmaceutical or biotech company setting
Deep experience working on early stage development programs and design (pre-IND, IND; deep experience in both Phase 1 and 2 required)
Ability to run a clinical program with minimal direction
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisive
Experience leading within a matrix organization, with excellent communication skills, managing vendors and contract research associations

Nice To Haves

Experience running immunology programs strongly preferred

Responsibilities

Lead the execution of clinical studies for assigned portfolio companies
Support, in collaboration with the CSO, Immunology and clinical operations leadership, the design and implementation of clinical development plans in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements and emerging issues
Maintain a high level of clinical and scientific expertise in a disease area(s) and relevant pathways by reviewing the literature, attending medical/scientific meetings, and through interchanges with consultants, thought leaders, investigators and internal stakeholders
Review and assess adverse events
Driving go/no go decisions based on safety signals
Ensure compliant safety reporting procedures
Oversee medical monitoring of ongoing trials
Review and address screening failures and protocol deviations
Provide medical guidance to clinical research sites
Train site staff on medical aspects of protocol
Field and address investigator questions