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
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