Senior Director, Clinical Strategy

Senior Director, Clinical Strategy
Allucent, Hungary

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
Jun 2, 2023
Last Date
Jul 2, 2023
Location(s)

Job 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.


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.


We are looking for a Senior Director Clinical Strategy to join our team remotely in Europe! The Senior Director Clinical Strategy is responsible for assisting clients with the Clinical activities of drug, biologic or medical device products. The Senior Director Clinical Strategy provides counsel to and manages the clinical strategy team; ensures timely preparation of organized and scientifically valid quality deliverables; translates clinical requirements into practical, workable plans and may lead or participate in Health Authority (HA) interactions as subject matter expert including correspondences, teleconferences, and meetings. The Senior Director Clinical Strategy reviews, provides advice on or authors clinical regulatory content for HA submissions, including reports, protocols, and other scientific documents. The Senior Director Clinical Strategy is knowledgeable in overall drug and medical device development process.


The Senior 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 Senior Director Clinical Strategy may have one or more direct reports.

Location: Europe

Workplace options: hybrid/remote/office-based

Experience: gt;10 year's experience in regulatory and clinical drug development

Therapeutic Expertise: Oncology (highly preferred)


The Senior Director, Clinical Strategy is responsible for the following tasks:

  • Reviews and/or writes clinical/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
  • Contributes significantly to strategic/clinical discussions and associated documents/reports regarding drug, biologic, or device development with primary emphasis on clinical aspects
  • Guides the writing of clinical/scientific documents written by other project team members
  • Has advanced scientific knowledge of HA Regulatory Guidance and Regulations
  • Interacts with various HAs, may include leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and preparing responses to inquiries
  • Contributes to Due Diligence Reviews / reports
  • Has advanced understanding of electronic common technical document (eCTD) format
  • Prepares clinical development plans and/or strategies from early development through Phase 4
  • Participates in meetings with clients and leads discussions in scientific area(s) of expertise as subject matter expert
  • Performs other scientist related duties, as assigned
  • Actively supports staff learning amp; 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?
  • 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

Job Specification

Job Rewards and Benefits

Allucent

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