Sr. Medical Director (Clin Dev)

EPM Scientific; United States; Remote; USD 275,000 - 350,000; Full time

Job summary

A global biopharma company seeks a Director for their Clinical Development team. This role emphasizes leadership in clinical strategy and operational excellence, contributing to innovative oncology treatments while ensuring compliance with medical governance and regulatory standards. Candidates should hold an MD and possess substantial experience in biotech or pharma, aiming to impact the organization’s clinical stage pipeline positively.

Qualifications

• Minimum 8 years of industry experience in biotech/pharma.
• 5+ years of management experience.
• Experience with FDA/EMA processes.

Responsibilities

• Lead clinical development operations for all trial programs.
• Oversee technical clinical governance and ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams.

Skills

Medical expertise

Leadership

Strategic planning

Clinical governance

Regulatory knowledge

Education

Medical Degree (MD)

Board Certified in Oncology

Job description

This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$275,000.00/yr - $350,000.00/yr

Direct message the job poster from EPM Scientific

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.
• Genuine remote growth opportunity at a reputable biopharma group
• 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

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing

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