- Salary
- $220k – $370k
- Location
- Boston, MA
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Director
- Experience
- 10+ years
- Closing date
- Today
- Source
- ApplyToJob
Description
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm is seeking a Senior Medical Director, Global Safety, to provide medical leadership and expertise across the safety of our products throughout development and commercialization. This individual will serve as a key medical safety expert and leader within the Global Safety organization, providing oversight and direction to safety physicians supporting Rhythm’s portfolio. The Senior Director will lead safety surveillance, signal evaluation, and ongoing benefit-risk assessment while partnering closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external partners. The Senior Director will bring strong clinical judgment and deep pharmacovigilance expertise to evaluate emerging safety information, inform program and regulatory strategy, and ensure safety considerations are integrated into key decisions across the product lifecycle.
Responsibilities and Duties
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role will involve some travel.
The expected salary range for this position is $220,000 – 370,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm is seeking a Senior Medical Director, Global Safety, to provide medical leadership and expertise across the safety of our products throughout development and commercialization. This individual will serve as a key medical safety expert and leader within the Global Safety organization, providing oversight and direction to safety physicians supporting Rhythm’s portfolio. The Senior Director will lead safety surveillance, signal evaluation, and ongoing benefit-risk assessment while partnering closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external partners. The Senior Director will bring strong clinical judgment and deep pharmacovigilance expertise to evaluate emerging safety information, inform program and regulatory strategy, and ensure safety considerations are integrated into key decisions across the product lifecycle.
Responsibilities and Duties
- Provide strategic medical safety leadership and oversight across Rhythm products and programs, including direction and oversight of safety physicians supporting the portfolio.
- Serve as the primary safety physician and medical subject matter expert for assigned Rhythm products, maintaining a comprehensive understanding of their evolving safety profiles.
- Lead safety surveillance, signal evaluation, and ongoing benefit-risk assessment activities, providing expert medical judgment on complex or emerging safety issues.
- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and other functions to integrate safety considerations into clinical development, regulatory strategy, and risk mitigation approaches.
- Identify, evaluate, and communicate potential safety concerns, ensuring timely escalation of significant safety findings to Global Safety leadership and relevant governance committees.
- Provide medical oversight for global PV processes and activities, working with internal functions, CROs, and PV vendors to ensure high-quality and compliant execution.
- Provide medical safety leadership on the development and review of clinical protocols, investigator's brochures, informed consent forms, safety management plans, aggregate safety reports, health authorities’ responses and other clinical, regulatory, and safety documents.
- Prepare for and participate in health authority interactions and provide medical safety expertise during regulatory inspections and audits.
- Contribute to the development, review and implementation of SOPs, Work Instructions, guidelines, and other tools pertaining to safety practices.
- Lead, manage, and develop safety physicians and scientists, providing clear direction, coaching, and oversight while building medical safety capabilities and ways of working as the organization grows.
- M.D. degree or equivalent required.
- Completion of postgraduate clinical training or residency preferred.
- At least 10 years of progressively responsible experience in pharmacovigilance/drug safety within the pharmaceutical or biotechnology industry, including significant experience providing medical safety leadership for clinical development programs and/or marketed products.
- Demonstrated experience leading medical safety teams and cross-functional safety activities or programs; people management experience strongly preferred.
- Strong understanding of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and other regional requirements.
- Demonstrated experience leading safety surveillance, signal detection, benefit-risk assessment, risk management, and aggregate reporting activities for investigational and/or marketed products.
- Familiarity with drug safety databases (previous experience with Argus is a plus), data analysis tools, and document management systems.
- Excellent oral and written communication skills with the ability to clearly communicate complex safety information to a range of internal and external stakeholders.
- Strong collaboration and interpersonal skills with the ability to influence effectively across functions and with external partners.
- Ability to manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure.
- Strong commitment to scientific rigor, quality, compliance, and operational excellence.
- Self-motivated and adaptable, with the ability to identify core challenges and adjust direction as priorities evolve in a fast-paced organization.
- High degree of professional ethics, integrity, and judgment.
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role will involve some travel.
The expected salary range for this position is $220,000 – 370,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Skills
FDARisk ManagementCompliance