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PharmaLex is a leading provider of specialized services to the pharmaceutical, biotech and medtech industries. Through our US, European and Asian offices, we provide integrated services through a complete range of strategic drug development offerings including Bench to Bedside Drug Development Consulting, Clinical and Regulatory Strategy, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.
We are currently looking for a Director/Senior Director, Integrated Product Development to support our Development Consulting and Scientific Affairs team. Understanding what is needed to bring new drugs to the market, the Integrated Product Development Team maintains a holistic “bench to bedside” perspective. The team provides expert development consultation encompassing product 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 successful candidate must have a minimum of 12 years of experience working for, or with 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. 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. Experience in a life science service delivery industry (e.g., consulting) is also strongly preferred.
Candidates should be dependable self-starters with a growth mindset looking to advance professionally and who bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset.
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As a Key Contributor You Will work closely with PharmaLex executives, consultants and clients to craft and implement Integrated Product Development Strategies and support clients with a variety of strategic services including but not limited to creating target profiles, conducting gap analyses, designing global regulatory and clinical strategies, managing Regulatory Agency meetings and completing due diligence assessments.
Reports to (title): Vice President, Development Consulting and Scientific Affairs
Number of direct/indirect reports: 1-2
Provisional budget: N/S
Travel expectations (in %): Up to 30%
Director/Senior Director, Integrated Product Development
Key Responsibilities and Activities
- Lead and/or support project teams from client kick-off to final deliverable, contributing to and overseeing technical and regulatory activities
- Strategic input into and management of regulatory Agency meetings and submissions (e.g., pre-IND/IND/End-of-Phase-2, orphan designations, PSP, NDA/BLA submissions, post-authorization maintenance)
- Research and recommend overall development and regulatory strategy, as well as navigating clients through the development process from bench to bedside
- Assess scientific data, including technical and regulatory review of CMC, nonclinical, and clinical summaries for regulatory submissions
- Maintain a 65% chargeability target
- 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 program management skills to achieve client strategic and business objectives, ensuring a positive customer experience with on-time delivery
- Anticipate problems before they arise in a project and implement risk mitigation steps as appropriate
- Able to manage multiple client projects simultaneously
- Diverse 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
- Support the overall DCS strategy globally, including implementation of regional and international business development efforts
- 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 account
- Other duties as assigned.
- Master’s or Doctoral degree in pharmacy, pharmaceutical development, chemistry or a life science discipline.
- Experience working on or preferably leading cross-functional teams in a drug development setting.
- A minimum of 12 years ‘hands on’ drug development experience including a thorough grasp of regulatory requirements
- Experience leading or playing a key role in FDA meetings. Additional experience with other global regulatory Agencies preferred
- Comfort with uncertainty and change, and 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, strategic thinking and problem-solving skills
- Autonomous, concentrated and high-quality work with attention to detail
- Ability to work in a team and experience leading cross-functional project teams
- Sense of responsibility and accountability
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
Agencies only by prior agreement for the specific job opportunity.