Medical Director -- in Clinical Science in Marketed Products Development

Eliassen Group; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Medical Director to support clinical science in marketed products development. This role involves providing medical oversight, collaborating with various teams, and ensuring compliance with regulatory standards. Candidates should have an MD and significant experience in clinical development and regulatory interactions.

Qualifications

• Approximately 6 years of industry experience in clinical development.
• Experience in regulatory agency interactions.
• Experience in clinical study data review.

Responsibilities

• Provide medical and clinical leadership for assigned products.
• Collaborate with cross-divisional stakeholders.
• Oversee compliance with internal SOPs and external legal requirements.

Skills

Collaborative skills

Clinical oversight

Regulatory knowledge

Education

MD or equivalent

Job description

Medical Director -- in Clinical Science in Marketed Products Development

Medical Director -- in Clinical Science in Marketed Products Development

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

Base pay range

$140.00/hr - $160.00/hr

Medical Director -- in Clinical Science in Marketed Products Development

CONTEXT

Eliassen Group and our client – one of the top 20 largest pharmaceutical companies globally -- are seeking an experienced MD to support 2-3 programs for about 6 months in Clinical Science in Marketed Products Development within Global Medical, with the possibility to extend based on program needs. This role requires an individual with a background in pharma/biotech/CRO.

DUTIES/EXPECTATIONS OF THIS ROLE

• This individual will be working closely with two Global Clinical Science Leads leading the programs. The Medical Director Marketed Products Development (MDMPD) Clinical Science is accountable for Medical Sponsor and Clinical oversight for assigned marketed products globally. The MDMPD is an integral member of an Marketed Products Development Team (MPDT) in Global Medical that is responsible for providing dedicated support for the products under its purview. The MDMPD interacts and partners with marketed products MPD affiliated function leads (regulatory affairs, global safety/pharmacovigilance, global development operations and project management) to set Global Medical strategy and prioritize functional area support for assigned MP portfolio.
• The MDMPD provides Medical Sponsor Oversight for all assigned products managed by the MPDT as part of the dedicated, integrated functional area support to ensure the company meets its corporate obligations as MAH for assigned products. The MDMPD provides medical and clinical leadership to make sure that the MPDT anticipates potential compliance risks and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
• The MDMPD will be required to be the medical and clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products in order to provide medical, clinical and scientific support, guidance,

Responsibilities and Accountabilities:

• Partner with Marketed Product Project Manager to coordinate functional support for assigned products within the MPDT. Provide medical and clinical scientific leadership and expertise for assigned products to support other function leads within the MPDT.
• Establish integrated partnership(s) with MPD affiliated functional leads in R & D (regulatory affairs, global safety/pharmacovigilance, global development operations).
• Collaborates with Sub Teams
• Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
• Forms integrated partnerships with and works with Global Product Team Leaders (GPL) as necessary, and ensures excellence in delivery of medical and clinical support and execution of clinical development activities/studies across assigned products.
• Medical Monitoring and supervisions and guidance for vendor medical monitors.
• Partners with strategic partner vendor(s) and drives medical and clinical scientific activities relating to the preparation/approval of protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed. Provides company oversight of strategic partner MDs/clinical staff involved in these activities.
• Oversee the strategic partner vendor(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, protecting the safety of patients within the study. Responsible for internal oversight of strategic partner vendor medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with global safety/Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity.
• Establish integrated partnership with strategic partner clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
• Determine how individual study results impact the product strategy. Interprets data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients.
• Support Local Operating Company (LOC) medical staff for all regulatory agency interactions as needed. Drive medical and clinical scientific input and development of required documents for regulatory applications/submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
• Oversee compliance with internal SOPs and external legal requirements, including training of personnel, contractual arrangements with external service providers and partner companies.
• Participates in meetings with regulatory agencies as required

MUST HAVES – QUALIFICATION SUMMARY

• MD (or equivalent) with experience in internal medicine and/or hematology, additionally rare disease area experience is preferred.
• Approximately 6 years of industry experience in clinical development. Less than 6 years might be considered based on specific areas of clinical development experience. Post marketing experience preferred.
• Experience in regulatory agency (FDA, EMA etc) interactions and contributing to clinical sections of submission documents
• Experience in contributing to safety reporting (e.g. PBRER)
• Experience in clinical study data review and preparation of clinical study reports
• Strong collaborative skills and experience in working in a matrix team environment.

TRAVEL & LOCATION

• Remote /home-based (ET or CT preferred)

START & TERM

• Start immediately following thorough screening and interview, background check
• 6-month contract (through early December 2025); possibility of extension based on program needs

RATE

• Hourly pay, market-rate

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing

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