Seasoned Global Program Manager
MS, MBA, PMP oncology and immuno-oncology drug development & program management leader with extensive global drug development experience. Expertise spans the continuum from IND candidate nomination to commercial product launch and life cycle management of in-line products; inclusive of NDA/MAA/BLA document preparation, submission and approval.
Proven ability to translate complex clinical/regulatory strategies into well-executed clinical development programs. Extensive knowledge of clinical oncology and experience in ensuring GCP-compliant clinical trial execution. A leader with excellent presentation skills and finely honed communication skills. Well versed in exercising influence without formal authority and establishing personal credibility throughout an organization.
Relevant Therapeutic Areas
- Oncology & Immuno-Oncology
- Monoclonal Antibodies
- Small Molecules
- Head of Program Management & Strategic Planning
- Senior Vice President, Clinical Development & Operations
- Mid-Atlantic Area
- Open to remote, travel, and in-office
- Small & Medium-Sized Biotechs
Skills & Accomplishments
- Bridged commercial and late-stage development activities & initiated commercial planning and access and reimbursement activities.
- Previous held project leadership responsibility for an entire clinical development portfolio, which included 16 active clinical-stage programs.
- Extensive experience with NDA/MAA/BLA document preparation, submission, and approval