Clinical Development Director

Overview

Responsibilities

• Define the overall clinical development plan for specific therapeutic assets from early phase to post-marketing.
• Lead the design of clinical trial protocols including endpoints, inclusion criteria, and statistical analysis plans.
• Oversee the preparation of clinical sections for regulatory submissions such as Investigational New Drug and New Drug Applications.
• Manage relationships with key opinion leaders and clinical investigators to ensure scientific rigor and trial recruitment.
• Present clinical data and strategic updates to internal steering committees and external advisory boards.
• Analyze emerging safety and efficacy data to make critical decisions regarding trial continuation or protocol amendments.
• Collaborate with clinical operations teams to ensure trials are executed within budget and established timelines.

Qualifications

• An advanced degree such as an MD, PhD, or PharmD in a relevant scientific or medical field is required.
• Extensive experience in clinical research within the pharmaceutical, biotechnology, or medical device industry is essential.
• Demonstrated success in leading clinical programs through multiple phases of the drug development lifecycle.
• Deep understanding of global regulatory guidelines including Good Clinical Practice and International Council for Harmonisation standards.
• Expertise in medical writing and the ability to interpret complex statistical data sets.

Nice to have

• Board certification in a specific therapeutic area relevant to the company's pipeline.
• Prior experience with successful New Drug Application or Biologics License Application submissions.
• Experience managing large-scale global trials involving multiple international sites.
• Strong network of established relationships with regulatory agencies and academic medical centers.

Work environment

• Work is typically performed in a professional office or corporate campus setting with flexible hybrid options.
• Collaboration involves frequent interaction with global teams across different time zones.
• The role requires occasional travel to clinical trial sites, medical conferences, and regulatory meetings.
• Standard business hours are common, though deadlines for regulatory filings may require extended periods of work.
• Tools include clinical data management systems, project management software, and secure document sharing platforms.

Benefits & growth

• Compensation often includes a high base salary supplemented by significant annual performance bonuses.
• Equity grants or stock options are standard components of the total rewards package in the biotech sector.
• Career progression typically leads to Vice President of Clinical Development or Chief Medical Officer roles.
• Professional development is supported through attendance at major medical congresses and executive leadership training.