Director - Clinical Scientist

Director, Clinical Scientist 2048178
Location: Remote
Focus: Rare Disease
Job Overview: The Clinical Scientist leads activities related to trial design, execution, and analysis of clinical trials. Represent, monitor clinical data, respond to regulatory queries, and SME on assigned protocols while addressing potential issues.
Primary Job Responsibilities:

• Lead the creation of clinical development plans, study synopses, and protocols, serving as the primary contact for clinical science inquiries.
• Monitor trial data for quality, manage tasks by external vendors, and maintain GCP compliance.
• Contribute to regulatory briefing packages, responses, and development for major regulatory submissions.
• Offer clinical and scientific input into regulatory documents, study reports, and ensure effective training and communication with study site staff.
• Represent clinical science in management teams and prepare presentation materials for various stakeholder meetings.

Primary Job Requirements:

• Advanced degree ( PhD-/MD-/PharmD-level (or equivalent relevant experience ) with 5+ years in clinical drug development, preferably with experience in rare disease trials.
• Expert in therapeutic areas, staying current with scientific advances and using knowledge to push projects forward.
• Acts as a resource in scientific education for stakeholders and participates in external scientific discussions.
• Knowledgeable about clinical trial regulations, skilled in protocol and document development, and interacts with regulatory bodies.
• Experienced in managing vendor relationships, including overseeing CRO activities, and excels in complex project management.
• Strong communicator, adept in oral and written presentations, capable of independent work and driving team success.
• Demonstrates leadership, thrives in teamwork, offers creative problem-solving, and holds accountability for team goals

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.