Director/Senior Director, Strategic Product Development

PharmaLex is now a part of Amerisourcebergen and is one of the largest providers of Development Consulting and Scientific Affairs; Clinical, Regulatory Affairs; Quality, CMC, Biostatistics, and Pharmacovigilance worldwide. Our Development Consulting and Scientific Affairs consultants provide specialized consulting across the product lifecycle to pharma, biotech and medical device clients to help them bring new therapies to the patients that need them.

We are seeking experienced and motivated individuals to join our growing US team. The successful candidate for the Director/Senior Director, Strategic Product Development must have a minimum of 10 years of experience working for, or as a service provider to pharmaceutical or biotech companies with an understanding of what is needed to gain marketing authorization and to support commercial success. The ideal candidate will possess diverse experience across multiple phases of development and have a strong working knowledge of the various cross-functional activities necessary to support successful drug development. Candidates must have demonstrated expertise in crafting global development strategies. Expertise in clinical regulatory strategy and supporting regulatory agency meetings is highly preferred. Our Strategic Product Development Team in Development Consulting 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 and execute 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 efficiency and value of the program.

Reports to (title): Vice President

Number of direct/indirect reports: 0-3

Provisional budget: N/S

Travel expectations (in %): Up to 15%

Work Location: Remote

Key Responsibilities And Activities

• 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
• Provide timely and constructive feedback to team members
• 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
• Research and recommend global development and regulatory strategy, as well as navigating clients through the development lifecycle
• Review and edit work of others, providing constructive feedback
• Challenge strongly held client assumptions with well-researched justifications, as appropriate
• Identify scope changes in projects and manage or bring to project lead attention
• Build, develop and maintain working relationships with clients, including establishing and maintaining relationships with senior management (C-Level) of key client accounts
• Respond to PharmaLex personnel requests/questions in a timely manner
• Provide appropriate structure for project team, especially junior members
• Lead and/or support project teams from client kick-off to final deliverable, contributing clinical and regulatory content expertise as appropriate
• Written and Oral Communication
• Work with client personnel to resolve issues/problems, responding to client requests in a timely manner
• 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)
• Manage client relationship when there are changes in scope or the project plan
• Work with Business Development (BD) to identify opportunities for follow-on / expansion of work within current projects
• Other duties as assigned
• Assess scientific data, including technical and regulatory review of CMC, nonclinical, and clinical summaries for regulatory submissions
• Communicate with health authorities on behalf of clients in a clear and concise manner
• Client Management
• Make effective presentations to client/sponsors and health authorities as appropriate
• Team Management (as appropriate)
• Utilize project management skills to meet project objectives and milestones, including management of client expectations and deliverables
• Provide recommendations on regulatory and development issues for clients
• Ability to interpret regulatory guidance documents and apply their meaning to client development strategies
• Anticipate problems before they arise in a project and implement risk mitigation steps as appropriate
• Business Development
• Lead the preparation of or play a key role in proposals, RFP responses, bid defense meetings and further client meetings as necessary
• Industry Knowledge
• Development Consulting and Program/Project Leadership
• Assist BD in creating new business opportunities through thought leadership, professional networking, conference attendance and other professional activities that promote the Pharmalex brand.
• Structure and independently prepare complex final deliverables, with on-time delivery

Required Education, Experience, Skills And Competencies

• Very good command of English, written and verbal and excellent written and verbal communication skills, including effective and professional client-facing interactions
• Post-graduate degree in pharmacy, pharmaceutical regulatory affairs, medicine, chemistry or a life science discipline.
• 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 work in a team and experience leading project teams
• Familiarity with global regulatory requirements, particularly the EU
• Autonomous, concentrated and high-quality work with attention to detail
• Sense of responsibility and accountability
• Good organization, analytical, and problem-solving skills

Key Performance Indicators

• Client and team members’ feedback
• Diligent and on-time entry of billable and nonbillable time by project code
• Successful execution of client deliverables within scope and on budget
• Adherence to PLx SOP and working instructions and timely completion of assigned trainings

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