Ensuring the highest possible quality of input into significant requests for proposals (RFPs)
Development strategy and regulatory issues
Drug class issues
Protocol and indication considerations, including safety
Team education on indication
Interactions with clients physicians and/or clients pneumology area leaders prior to and during bid defenses
Identifying business opportunities for PPD
Supporting outstanding input into other areas of PPD’s business activities
Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies whose portfolio contains drugs of business interest to PPD
Strategic alliance development & support
Client governance and advisory boards
Providing therapeutic and developmental expertise to internal PPD’s teams, including indication specific trainings for clinical teams
Guidance during clinical trials executions
Investigator Brochure, clinical study report, NDA/MAA clinical packages development, and other regulatory briefing documents authoring and review
Contributing to design and reporting of feasibility studies
Liaising with investigators and KOLs
Mentoring and supervising PPD’s clinical scientists
Participating in multidisciplinary teams and working groups
Requirements
Certified pediatrician with at least 7-10 years’ experience in pharmaceutical industry or government/regulatory agency leading clinical development of at least one asset from discovery through registration
Able to work in a matrix organization
Able to demonstrate the following key high-level high-performance behaviors: decisive, customer driven, flexible thinking, smart-risk taking and continuous improvement
Leads, influences and motivates staff within and across departments
Strong in presenting and communicating complex information clearly
Able to deal with sensitive and confidential issues
Possesses a 'can do' attitude and is capable of implementing and following through on activities/projects
Proficient in spoken and written English
Flexibility to travel domestically and internationally
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentregulatory briefing documentsNDA/MAA clinical packagesfeasibility studiesinvestigator brochureclinical study reportdrug class issuesprotocol considerationssafety assessmentstherapeutic expertise