Sr. Medical Director (Clin Dev)

Job Type: Full-time

Salary: $275K - $350K

Location: Remote

Company Summary: A global biopharma committed to innovation and accessibility in the oncology and autoimmune spaces. With 50+ molecules in R&D, they also have a proven track record for continued success and stability with commercially successful products in 7+ countries. This is a rare "best of both worlds" situation - a biotech environment where drug development is the forefront of their priorities and a the stability of larger organizations with approved products.

The Opportunity: Join as a leader of the clinical development team and strategy. You will have a significant impact on the advancement of their clinical stage pipeline, in addition to, leadership responsibility over the clinical/medical science teams. As a leader, you'll be expected to represent the organization at conferences, forums, and in investigator meetings.

Responsibilities:

• Leading Clin Dev operations for all clinical trial programs which includes strategic leadership and leadership of trial design/execution & medical governance
• Providing medical expertise to points of contacts such as - internal or external collaborators, investigators, consultants, business development, and investors.
• Collaborating alongside cross functional leaders to ensure the oversight of global medical monitoring activities
• Overseeing of clinical budgets related to projects to ensure quality, timely, and cost-effective delivery
• Building out the medical team in relevant therapeutic areas as organization grows
• Optimizing each therapeutic area and ensuring overall clinical excellence in accordance with ethical conduct of trials
• Overseeing clinical trial protocol development and amendment process
• Serving as the POC for medical governance of the trials while ensuring compliance with GCP,ICH guidelines and regulatory requitement
• Drafting and reviewing regulatory documents and participating in meeting with regulatory bodies
• Contributing to medical writing and reviewing protocols and other study critical documents
• Maintaining strong relationships with key external stakeholders, partners, KOLs, investigators, consultants, and patient advocacy groups
• As a leader, fostering a culture of excellence and continuous improvement

Requirements:

• Medical Degree (MD) and Board Certified in Oncology.
• 8+ years of industry experience (biotech/pharma)
• 5+ years of experience managing direct reports
• Ph I-III experience
• Experience with FDA/EMA processes
• Some travel may be required.

Benefits:

• Genuine remote growth opportunity at a reputable biopharma group
• Comprehensive health benefits (medical, dental, and vision) & 401K contribution
• Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide
• Work with an experienced group of leaders with diverse experience and a passion for treating cancer