We are growing, grow with us!
PharmaLex is one of the largest providers of Development Consulting and Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech and MedTech industries to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch.
We are seeking experienced and motivated individuals to join our growing US team. The successful candidate for the Director/Senior Director, Strategic Integrated Product Development must have a minimum of 10 years of experience working for, or as a service provider to pharmaceutical or biotech companies with diverse experience across multiple phases of development and including a strong working knowledge of the various cross-functional activities necessary to support successful drug development. Candidates must have demonstrated expertise crafting global development strategies with a focus on clinical and non-CMC regulatory strategy. Understanding what is needed to bring new drugs to the market, the Integrated Product Development Team maintains a holistic “bench to bedside” perspective and provides expert development consultation encompassing global development strategy, regulatory and clinical strategy, Agency meeting support, and integrated development planning, among others. You will be collaborating with highly experienced professionals with both Industry and FDA experience across the range of Pharmalex service offerings. The ideal candidate will have demonstrated expertise in strategic thinking, interpreting scientific data, leading teams in a matrix environment and experience leading or participating as a key participant in Regulatory Agency Meetings.
PharmaLex is a proud to be an equal opportunity employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skill, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
As a Key Contributor You Will work closely with PharmaLex consultants to craft implement Integrated Product Development strategies with multiple clients and support clients with their regulatory strategy, identifying potential gaps and providing expert recommendations on how to maximize the value of the program.
Reports to (title): Vice President
Travel expectations (in %): Up to 20%
Director/Senior Director, Strategic Integrated Product Development
- Lead and/or support project teams from client kick-off to final deliverable, contributing clinical and regulatory content expertise as appropriate
- Strategic input into and management of regulatory agency meetings, submissions and procedures (e.g., pre-IND/IND/End-of-Phase-2, orphan designations, PSP, NDA/BLA submissions, post-authorization maintenance)
- Research and recommend global development and regulatory strategy, as well as navigating clients through the development process
- Assess scientific data, including technical and regulatory review of CMC, nonclinical, and clinical summaries for regulatory submissions
- Represent clients to the FDA, including acting as the primary contact point and taking a leading role in teleconferences and face-to-face meetings with FDA
- Utilize project management skills to meet project objectives and milestones, including management of client expectations and deliverables
- Anticipate problems before they arise in a project and implement risk mitigation steps as appropriate
Identify scope changes in projects and manage or bring to project lead attention
- Diverse non-CMC experience across multiple development phases and a strong working knowledge of the various cross-functional activities needed to bring new products to market
- Ability to interpret regulatory guidance documents and apply their meaning to client development strategies
- Provide recommendations on regulatory and development issues for clients
- Communicate with health authorities on behalf of clients in a clear and concise manner
- Structure and independently prepare complex final deliverables, with on-time delivery
- Review and edit work of others, providing constructive feedback
- Make effective presentations to client/sponsors and health authorities as appropriate
- Solicit feedback from reticent clients or team members
- Communicate with client and health authorities at the appropriate level of detail
- Work with client personnel to resolve issues/problems, responding to client requests in a timely manner
- Manage client relationship when there are changes in scope or the project plan
- Challenge strongly held client assumptions with well-researched justifications, as appropriate
- Maintain meaningful relationships with clients after project is completed, keeping PharmaLex business development apprised
- Actively seek out new client relationships/new business opportunities on behalf of PharmaLex
- Provide appropriate structure for team, especially junior members
- Respond to PharmaLex personnel requests/questions in a timely manner
- Provide timely and constructive feedback to team members
- Work with Business Development (BD) to identify opportunities for follow-on / expansion of work within current projects
- Assist BD in creating new business opportunities through thought leadership, professional networking, conference attendance and other professional activities that promote the Pharmalex brand.
- Lead the preparation of or play a key role in proposals, RFP responses, bid defense meetings and further client meetings as necessary
- Build, develop and maintain working relationships with clients, including establishing and maintaining relationships with senior management (C-Level) of key client accounts
- Post-graduate degree in pharmacy, pharmaceutical regulatory affairs, medicine, chemistry or a life science discipline.
- Ideally a minimum of 10 years experience in drug development ideally including leadership of cross functional teams accountable for bringing new assets to the market
- ‘Hands on’ regulatory strategy and experience in a broad range of regulatory submission types with a thorough grasp of US regulatory requirements.
- Experience leading or participating in FDA meetings
- Ability to adapt under regularly changing conditions
- Very good command of English, written and verbal and excellent written and verbal communication skills, including effective and professional client-facing interactions
- Good organization, analytical, and problem-solving skills
- Autonomous, concentrated and high-quality work with attention to detail
- Ability to work in a team and experience leading project teams
- Sense of responsibility and accountability
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.