Qualifications
MD or MD/PhD required
Minimum of 12-15 years clinical development experience, preferably some experience in pharmaceutical companies, including a strong background in rare disease development and clinical trial design.
Minimum of 5 years of hands-on experience: leading a large, global cross functional teams for product development with evidence of success for obtaining EOP2 and/or MAA/NDA.
Proven history of late stage drug R&D successes as evidenced in documented regulatory success milestones (EOP2, NDA, MAA) and publications
High level of expertise in drug development under setting of 505(b)(1), fast track, accelerated approval and breakthrough therapy. BLA and/or 505b2 experience is a plus..
Experience in orphan diseases and immune or dermal therapeutic area is preferred.
Experience managing/leading global, KOL’s & cross-functional teams is required
Experience in HEOR (Health Economic Outcomes Research);
Experience in PRO (patient reported outcome) Measures
Experience oral clinical development programs, IV development experience is a plus.
Superior interpersonal skills coupled with multicultural awareness. Able to successfully establish relationships, communicate effectively within/across company disciplines, and thrive within a global, highly matrixed organization.
Superb leadership, mentoring and motivational skills; able to marshal teams to achieve goals.
Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and commitment to high quality and on-time deliverables.
A highly analytical and scientific mind coupled with business acumen; thinks both strategically and tactically.
Outstanding computer skills.