Medical Director, Clinical Science | Marketed Products
6 Month Contract | Extension possible
We're seeking a Medical Director, Marketed Products Development Clinical Science Consultant to support 2-3 programs.
Will provide Clinical and Medical Leadership across multiple global programs in a post-marketing setting. You'll serve as Medical Sponsor for assigned marketed products, shaping strategy, ensuring compliance, and collaborating cross-functionally (regulatory, safety, ops, PM) to support lifecycle management. It's a hands-on, high-impact role within a matrixed Global Medical environment, ideal for an MD with strong scientific, regulatory, and post-marketing experience.
Key Qualifications:
- MD; internal medicine and/or hematology experience preferred
- Rare disease and post-marketing experience
- 6 years of clinical development experience Biotech/Pharma
- Regulatory (FDA/EMA) engagement and submission contributions
- Safety reporting (e.g. PBRER) and CSR preparation
- Strong data review and cross-functional collaboration skills
location: Telecommute
job type: Contract
salary: $160.00 - 176.67 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Scope of Work Includes:
- Serve as medical/clinical lead for assigned marketed products, driving cross-functional collaboration across R&D, regulatory, safety, operations, and commercial teams
- Provide strategic oversight of clinical development, medical monitoring, and vendor deliverables for post-marketing and lifecycle management studies
- Partner closely with Global Product Teams, Established Product Teams, and external strategic vendors to ensure scientific rigor, patient safety, and data integrity
- Lead preparation and review of clinical documents for regulatory submissions (e.g., protocols, CTDs, PBRERs), and represent the company in global regulatory interactions
- Mentor internal/external stakeholders, support due diligence, and contribute to the evaluation of new business and licensing opportunities
qualifications:
- MD with experience in internal medicine and/or hematology
- 6+ years of industry experience in clinical development
- Experience with regulatory agency interactions (FDA, EMA, etc.)
- Proven contributions to clinical sections of submission documents
- Experience in safety reporting (e.g., PBRER)
- Experience in clinical study data review and clinical study report preparation
- Knowledge of nonclinical and clinical drug discovery and development
- Familiarity with TMS and state-of-the-art technologies
- Understanding of regional and global regulatory requirements
- Strong knowledge of GCP/ICH guidelines
- Rare disease experience
- Post-marketing experience
- NDA/MAA/submission experience
skills: NDA, Maa, GCP (Good Clinical Practice), Drug Safety, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
