Director, Clinical Strategy
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.
These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
Location: REMOTE EUROPE
The Director Clinical Strategy is responsible for assisting clients with clinical strategy related development activities of drug, biologic or medical device products. The Director Clinical Strategy leads, develops and coordinates the activities of the Clinical Strategy team; ensures timely preparation of organized and scientifically valid quality deliverables; translates regulatory requirements into practical, workable plans and may lead or participate in Health Authority (HA) interactions as subject matter expert. Responsibilities may include provision of strategy, review and authoring of clinical/scientific documents. The Director Clinical Strategy is knowledgeable in overall drug development process.
The Director Clinical Strategy will 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 Director Clinical Strategy may have one or more direct reports.
Key Responsibilities
Reviews and/or writes clinical/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
Has advanced knowledge of HA Regulatory Guidance & Regulations pertaining to clinical strategy through all phases of drug or device development and lifecycle management
Reviews and prepares HA questions and briefing documents.
Attends / may lead HA meetings as Clinical Strategy SME
Provides strategic advice and expertise in translating clinical requirements into practical plans and solutions
Has advanced knowledge of CTD format and structure for regulatory submissions
Contributes to Due Diligence Reviews / reports
Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality
Mentors less experienced Clinical Strategy Scientists
Participates in interdepartmental communications to assist with compliance with regulations.
Takes accountability for responsibilities in area of expertise
Performs other scientist related duties as assigned
Director with and without direct reports:
Actively supports staff learning & development within the company
Provides guidance and advises Project Leads, and/or Project Teams
Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources
Manages projects as a Technical Lead as assigned
Leads and/or participates in meetings with clients
Provides mentorship to team members
Acts professionally with peers and clients, knows business etiquette
Director with direct reports:
Provides training to direct reports on current and new regulatory requirements
Develops and presents internal and sponsor training
Actively manages direct reports including development and performance management
Tracks line report utilization and capacity
Coaches, mentors, and develops reports on collaborative consulting
Applies company policies and procedures to resolve a variety of issues
Identifies and mitigates risk
Assures good communication and relationships with clients
Assists in the evaluation of potential technologies
Reviews business development proposals, project cost structures and participates in bid defenses
Monitors and evaluates industry trends to leverage service offerings to ensure business growth (new opportunities and expansion of current client business)
Actively manages, develops, and strengthens client relationships, drives repeat business
Contributes to and participates in client evaluations
Requirements
Requires a B.Sc., M.Sc., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
Advanced scientific and regulatory knowledge of drug, biologic, or device development
Critical thinking and analytical skills, as well as strong written and verbal communication skills in English
Strong computer skills, including, Word, Excel, and PowerPoint
Quality focus
Strong emotional intelligence, customer focused leadership and decision-making skills
Innovative, creative, and practical thinking including problem-solving skills
>8 years’ experience with regulatory requirements of US FDA, Health Canada and/ or European authorities
Benefits
Comprehensive benefits package
Competitive salaries per location
Financially rewarding Talent Acquisition Sourcing Bonus Program
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for hybrid/remote working (depending on location)
Internal growth opportunities and career progression
Opportunity to support global recruitment efforts
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
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Allucent
Fecha de publicación: 04/04/2023
