AD, Medical Assessment and Signal Detection Lead, GPS Medical Science - ID:2006b

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology. Guided by core values of Patients, Science, and Passion, we use our TransCon® drug development platform to develop new and potentially best-in-class therapies addressing unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can grow and develop their skills.

About the role

The Medical Assessment and Signal Detection Lead is responsible for the medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing. This role involves performing signal detection activities, collaborating with program safety leads, and ensuring quality in partnership with the PV operations team. The Lead also supports Program Safety Leads with tasks assigned by the Head of GPS Medical Science.

Responsibilities

• Conducts medical review, assessment, and approval of ICSRs from clinical trials and post-marketing.
• Supports Pharmacovigilance Department direction, standards, and processes for corporate safety monitoring activities.
• Performs Quality Control reviews of assigned cases to ensure accuracy, integrity, medical reviews, and completeness of information in the safety database.
• Liaises with Medical Monitors in Clinical Development to ensure appropriate medical review and assessment of adverse event reports and non-clinical safety findings.
• Analyzes, identifies, and reports possible trends and concerns regarding Ascendis products and key competitive products, including safety signal identification and evaluation through single case reports, aggregate safety reports, and literature review.
• Provides medical and safety input for expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report).
• Collaborates with and provides pharmacovigilance guidance for interdepartmental and corporate initiatives.
• Offers pharmacovigilance expertise to Ascendis or CRO/Vendor staff as needed.
• Leads or contributes to responses to safety queries from Regulatory Authorities under the direction of the Head of GPS Medical Science.
• Monitors industry best practices and global safety regulations, recommending updates to departmental policies, SOPs, and systems.
• Supports preparation and maintenance of departmental policies and SOPs for processing, analyzing, and reporting safety information.
• Supports Program Safety Leads with tasks assigned by the Head of Medical Safety Science.
• Coordinates with Ascendis GCP and PV Compliance teams for PV-related regulatory inspections or audits.

Requirements

• 5+ years’ experience in Pharma, including a thorough understanding of PV processes.
• Expertise in safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment.
• Working knowledge of FDA, EMA PV regulations, ICH Guidelines, and other applicable global safety regulations.
• Strong collaboration and communication skills.
• Ability to work effectively in an agile and fast-paced environment.
• Ability to travel up to 20% of the time domestically and internationally.

This is a hybrid role operating preferably out of Palo Alto, CA; however, we welcome candidates residing near our Princeton, NJ office.

Pay

The estimated salary range for this position is $220–235k, dependent on experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or incentive compensation plan, discretionary stock-based long-term incentives, and other incentive compensation plans.

Benefits

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short- and long-term disability benefits
• Pet Insurance and Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development
• Health Savings Account (HSA)
• Flexible Spending Accounts
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents