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PharmaLex is one of the largest providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through our US, European and Asian offices, we provide integrated drug development services through a complete range of offerings including regulatory strategy and operations, quality management and compliance, pharmacovigilance and life-cycle management. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.
We are currently looking for a Director, Integrated Strategic Development to support our Development Consulting team. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
This position can be based in our Burlington, MA office or fully remote with travel as necessary.
Please apply directly by clicking here.
As a Key Contributor You Will work closely with PharmaLex consultants to implement Integrated Strategic 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): Senior Director
Number of direct/indirect reports: N/A
Travel expectations (in %): Up to 20%
Director, Integrated Strategic 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 submissions and procedures (e.g., pre-IND/IND/End-of-Phase-2, orphan designations, PSP, NDA/BLA submissions, post-authorization maintenance)
- Research and recommend 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
- 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
- Identify opportunities for follow-on / expansion of work within current projects
- Establish useful venues to take action on developing the opportunities into proposals
- Lead the selling effort in obtaining significant add-on work for existing clients
- Lead selling efforts for obtaining work from new clients
- Bachelor’s degree in pharmacy, pharmaceutical regulatory affairs, medicine, chemistry or a life science discipline with a graduate degree preferred.
- Ideally a minimum of 10 years ‘hands on’ regulatory affairs role and experience in a broad range of regulatory submission types with a thorough grasp of US regulatory requirements.
- Experience participating in FDA meetings
- Ability to work in a team and experience leading project teams
- Excellent written and verbal communication skills, including effective and professional client-facing interactions
- Sense of responsibility and accountability
- Autonomous, concentrated and high-quality work with high attention to detail
- Ability to adapt under regularly changing conditions
- Outstanding organization, analytical, and problem-solving skills
- Very good command of English, written and verbal
- Flexible scheduling around core hours
- Paid Vacation & Sick time
- 10 paid holidays (including floating holidays)
- Full benefits package including:
- Medical (PPO & HDHP)
- FSA, Dependent Care FSA & HSA Accounts
- Company paid life and AD&D insurance
- Company paid short- and long-term disability insurance
- 401(K) with match
- Parental Leave Policy
- Employee Assistance Program
- Tenure Recognition Program
- Employee Referral Program
- Tuition Reimbursement Program
- Paid volunteer hours
Please apply directly by clicking here.
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.