Sr Medical Director

Actalent • Morrisville, NC • 23h ago

Exciting Medical Director Opportunity!

Job Description

The Director, Clinical Development Scientist in the endocrinology and bone metabolism therapeutic area plays a pivotal role in the design and execution of clinical studies. This position involves leading cross-functional teams, contributing to global clinical development plans and strategy, and supporting clinical development physicians and therapeutic area heads with necessary deliverables for efficient clinical plan design and execution.

Responsibilities

Lead a team in preparing clinical study-related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.

Design clinical protocols and engage with relevant stakeholders, ensuring thorough preparation for protocol review.

Supervise and develop clinical development scientists and fellows, managing multiple studies concurrently.

Participate in Investigator meeting planning and execution, and oversee on-site initiation meetings.

Monitor, clean, analyze, and review safety and efficacy data, identifying trends and following up as appropriate.

Guide study oversight, including country and site selection, site training, start-up, and data monitoring.

Collaborate with external experts and design consultations to develop study concepts, protocols, and essential documents.

Engage with clinical investigators to ensure quality clinical execution and analyze clinical data.

Serve as the Subject Matter Expert for identification, translation, inclusion, implementation, and reporting related to liquid, tissue, and imaging endpoints.

Maintain awareness of scientific, clinical, competitive, and regulatory developments impacting the development plan.

Support business development activities, such as due diligence and research collaborations.

Lead translational science efforts for one or more programs.

Essential Skills

Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree).

5+ years of industry experience in clinical development.

Understanding of therapeutic principles and clinical research methodology.

Knowledge of statistics, data analysis, and interpretation.

Experience preparing clinical trial applications and monitoring activities.

Familiarity with regulatory documentation and clinical trial report preparation.

Ability to communicate effectively with internal and external stakeholders.

Additional Skills & Qualifications

Preferred advanced knowledge in the bone metabolism and endocrine space.

Experience in clinical development within industry CRO/Sponsor/Pharma.

MD with endocrinology and bone metabolism experience.

Pay and Benefits

The pay range for this position is $159.00 - $179.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Aug 6, 2025.

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