Vice President, Head Of Cmc

Description

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

Location: United States (REMOTE)

Summary:

The Vice President, Head of CMC is responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. Responsibilities may include analysis/review of drug substance synthesis, pre-formulation and formulation evaluation, analysis of manufacture, scale-up and process validation, providing support of analytical methods development and validation, and evaluation of packaging and labeling components. The CMC Vice President leads and/or participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The CMC Vice President reviews, provides advice on, or authors CMC-related regulatory content for HA submissions including reports, protocols, and other scientific documents.

The CMC Vice President may serve on project teams in various capacities including but not limited to: Subject Matter Expert, Technical Lead, Assistant Consulting Project Lead, and Consulting Project Lead.

The CMC Vice President may manage 1 or more direct reports.

Requirements

• Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions
• Contributes and participates in client evaluations
• Assists in the evaluation of potential technologies
• Applies company policies and procedures to resolve a variety of issues
• Reviews business development proposals, project cost structures and participates in bid defenses
• Identifies and mitigates risk
• Participates in meetings with clients and leads discussions in scientific area(s) of expertise as subject matter expert
• Office environment with ability to lift up to 25 pounds, if required
• Contributes to other areas of business as required
• Monitors and evaluates industry trends to leverage service offerings to ensure business growth (new opportunities and expansion of current client business)
• Travel may be required
• Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations
• May provide expertise in GMP and GLP audits, inspection readiness and remediation activities
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development
• Applies company policies and procedures to resolve routine and complex issues; contributes significantly to problem solving and solution shaping for difficult client issues as needed
• Assures good communication and relationships with clients
• Has advanced scientific knowledge of HA Regulatory Guidance and Regulations
• Performs other scientist or management related duties, as assigned
• Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and preparing responses to inquiries
• Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
• Guides the writing of regulatory/scientific documents written by other project team members, resolves technical problems
• Reviews or prepares product development plans and/or strategies from early development through Phase 4
• Actively manages, develops, and strengthens client relationships, drives repeat business

Vice President with direct line reports:

• Develops and presents internal and sponsor training
• Tracks line report utilization and capacity
• Actively manages direct reports including development and performance management
• Coaches, mentors, and develops reports on collaborative consulting
• Provides training to direct reports on current and new regulatory requirements

Vice President with or without direct line reports:

• Leads and/or participates in meetings with clients
• Provides mentorship to team members
• Actively supports staff learning & development within the company
• Acts professionally with peers and clients, knows business etiquette
• Provides guidance and advises Project Leads, and/or Project Teams
• Manages projects as a Consulting Technical Lead as assigned
• Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources

Qualifications:

• Requires a B.S., RPh., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant in drug, biologic, or device development
• Advanced scientific and regulatory knowledge of drug, biologic, or device development

Skills:

• Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
• Innovative, creative, and practical thinking including problem-solving skills
• Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
• Quality focus
• Strong emotional intelligence, customer focused leadership and decision-making skills
• >15 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable

Benefits

• Financially rewarding internal employee referral program
• Internal growth opportunities and career progression
• More task variety and project opportunities
• Comprehensive benefits package
• Flexible Working hours (within reason)
• Departmental Study/Training Budget for furthering professional development
• Competitive salaries per location
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.