Our publicly traded partner is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.
With over 1 billion dollars raised and internal talent that is second to none, this partner is poised for continued success. Our partner is driven to transform the care of patients with or at risk of serious infectious diseases. They are taking aim at some of the world’s largest and most serious infectious diseases, infections that have long been evasive, challenging, or insufficiently addressed by current approaches. In addition to their existing robust pipeline, they are forging ahead with multiple clinical candidates for covid-19. The patient is always the focus.
Our partner has multiple platforms, multiple modalities, and multiple collaborative partnerships….with a single vision. That one day, diseases like hepatitis B, HIV, and others become a thing of the past. With you leading this expanding group, you will oversee a team of 5-10 direct reports with a cross-functional team of up to 40.
This highly visible and critical hire will build out, manage, and lead one of the best infectious disease groups in the entire world reporting directly into the CMO. You will exude confidence and a team driven mentality in all that you do. Your hunger, tenacity, humility, and pursuance of excellence will insure your success.
As the VP/ SVP of Clinical Research & Development you will be responsible for overseeing the successful development of multiple molecules in the pipeline. To include the planning, design, and oversight of clinical studies from IND/CTA through worldwide registration and beyond.
- Manage, develop, and oversee a team of direct reports within Clinical Research to support relevant development programs.
- Be a strategic clinical leader responsible for shaping creative and efficient clinical development strategies for multiple pipeline assets
- Interface extensively with research colleagues and external experts to conduct collaborative research efforts, obtain feedback on clinical development plans, and stay abreast of new developments in the relevant fields.
- You will be a critical partner to counterparts in Research, Regulatory, Development Operations, Biometrics, and other expertise areas.
- Will build and lead a team of clinical research physicians, clinical scientists, and other necessary personnel.
- You will be a key spokesperson at external meetings, including regulatory interactions and scientific meetings.
- Partner with the CMO and others to help build and lead a world-class, development organization as our client grows toward realizing its vision towards creating a world without infectious disease.
- As needed, support the CMO in fundraising, Diligence, IR, and PR efforts, including support of non-dilutive initiatives such as Public-Private Partnerships (P3).
Clinical Development Objectives:
- Collaborate with Research and Translational Development to identify drug targets and disease indications, and shape clinical development plans.
- As molecules advance into the clinic, you will work with development operations and regulatory colleagues to oversee the design and timely progression of associated clinical trials.
- Provide leadership to all clinical research subteams via direct management of other MDs and clinical scientists.
- As the therapeutic head you will drive and lead all development strategy and trial execution for the chronic infections portfolio including: Hepatitis B, HIV, and Tuberculosis.
- Play a leadership role in regulatory interactions to advance molecules through development and secure global regulatory approvals.
- Collaborate closely with relevant functions to ensure strategic integration of product development plans.
- Be accountable for all relevant timelines and deliverables.
- Supervise closely all major written deliverables (protocols, clinical contributions to regulatory submissions, original articles, abstracts), and presentation materials.
- Influence internal and external audiences in a high impact, highly visible fashion.
- Work with the TCD (Translational and Clinical Development) Leadership Team to build and grow a highly effective development organization.
For more information, contact Shawn Friend firstname.lastname@example.org