Scientific Director

Mix Talent; Cleveland (OH); Remote; USD 120,000 - 180,000; Full time

Job summary

An innovative biotechnology firm is seeking a Scientific Director to lead strategic scientific initiatives. This pivotal role involves providing medical input into core medical affairs, collaborating on clinical use qualifications, and supporting regulatory communications. The ideal candidate will possess an advanced scientific degree and extensive experience in clinical trials, with a deep understanding of cell and gene therapy. Join a dynamic team dedicated to advancing cutting-edge therapies and making a significant impact in the healthcare landscape.

Qualifications

• Advanced scientific degree required, with a focus on clinical trials and regulatory knowledge.
• Strong communication skills and ability to manage stakeholder interactions.

Responsibilities

• Provide medical input into core medical affairs and support regulatory communication with the FDA.
• Collaborate in site qualification for clinical use and lead data generation initiatives.

Skills

Clinical Trials

Regulatory Requirements

Communication Skills

Stakeholder Interaction

Cell & Gene Therapy Knowledge

Education

Advanced Scientific Degree (NP, PhD, MD/DO, PharmD)

Job description

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Location: Remote - Full-Time

The Company is seeking a seasoned Scientific Director to join their team.

The Scientific Director plays a pivotal role, providing strategic scientific leadership and driving the advancement of pz-cel.

Responsibilities:

• Provide medical and scientific input into core medical affairs activities, including healthcare professional and payer interactions, generation of clinical data, educational initiatives, and safeguarding patient safety.
• Assist in onboarding and training Centers of Excellence (COEs) to use pz-cel in a commercial setting.
• Collaborate in site qualification for clinical use of pz-cel.
• Work with the Executive Medical Director on medical education development and implementation for COEs.
• Address medical and off-label inquiries, assess adverse events, and assist in medical monitoring and reporting.
• Support regulatory communication with the FDA.
• Promote the company's assets at scientific conferences and foster relationships with Key Opinion Leaders (KOLs).
• Lead data generation initiatives and support publication efforts.
• Manage HEOR projects to demonstrate pz-cel’s value and participate in payer negotiations.
• Support launch activities, including travel and operating room assistance, and focus on ongoing development assets post-launch.

Qualifications:

• Advanced scientific degree (NP, PhD, MD/DO, PharmD).
• Experience in clinical trials, clinical development, and understanding of regulatory requirements.
• Development strategy, protocol design, and clinical development experience.
• Excellent communication skills and stakeholder interaction capability.
• Knowledge of cell & gene therapy is essential.
• Ability to travel at least 30%.

Job Identifier: #7750

Additional Details:

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Research
• Industries: Biotechnology, Research, Pharmaceutical Manufacturing