Medical Affairs/Safety- Director, Product Lead MD

Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of products. " Serve as the safety expert providing strategic input to key stakeholders in relation to product safety, understanding the business strategy for the product, and being knowledgeable about the (medical) context of the respective product class.

Title: Director, Product Lead MD
Location: Cambridge or Virtual
Time Zone: EST or CST
Work Arrangement: Hybrid or Remote
Contract: ASAP 12/1/2026
Schedule: Full-time, normal business hours

Role Overview

• Individual will provide coverage for a maternity leave.
• Operational/non-manager role; will not have direct reports.
• Ideal candidate previously worked as a Safety Lead in a PV setting.
• Strong understanding of:
  • Clinical development
  • Drug/product safety
  • Risk management
  • Safety/PV processes
• Must be able to work effectively across the organization and with safety and product leadership.

Required/Preferred Experience

• Previous Safety Lead experience in a PV environment.
• Strong clinical development knowledge.
• Strong understanding of safety and risk management.
• Excellent written and verbal communication.
• Strong scientific acumen.
• Strong presentation/communication skills.

Systems / Technical Skills

• ARGUS Safety -Highly preferred
• Signaling tool Empirica plus
• Experience with other safety signaling tools is helpful.

Education / Licensing

• Active medical license is not required.
• MD experience is required to be from the U.S. or EU with relevant clinical experience.
• MD Schooling can have been from anywhere

Interview Process

• 2 rounds

Detail Job Description:
Safety Lead, Contractor, Safety and Risk Management
Summary of Key Responsibilities
" Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of products.
" Be the author and accountable content owner for all safety relevant content or documents during clinical development (e.g. ICF, Risk Language, IB, DSUR, Development RMP) and post approval (e.g. PSUR, RMPs answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters as needed.
" Be accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
" Provide analysis and presentation of safety data in multidisciplinary teams (e. g. Safety Risk Management Teams).
" Serve as the safety expert providing strategic input to key stakeholders in relation to product safety, understanding the business strategy for the product, and being knowledgeable about the (medical) context of the respective product class.
" Collaborate with SRM colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues.

Qualifications
The ideal candidate will have the following mix of personal and professional characteristics:

" MD degree with a minimum of 3 years of medical practice is a must.
" Must have a minimum of 3years of pharmaceutical industry experience as a product/program lead within pharmacovigilance
" Experience in clinical research/clinical development is a plus.
" Knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools and processes and relevant regulatory framework is required.
" Must have sound clinical acumen and a wide range of therapeutic area knowledge.
" Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment.
" Excellent communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
" Excellent networking and relationship building skills for successful cooperation with internal and external customers.
" Expertise in international regulations governing drug safety and experience in managing compliance through audits and inspections. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred.
" Excellent interpersonal and decision-making skills. Strong influencing skills with the ability to quickly earn credibility across other functional areas.
" Ability to work in fast-paced environment with rapidly approaching timelines is important

Why TalentBurst?
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We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.