Associate Dean Of Clinical Affairs - Hs Associate / Full Clinical Professor

3-5 years

$96,500 - $286,000

Berkeley

10 March 10, 2025

Job Description

Job Type: Full Time Education: D.O. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Global PV Operations
Job ID: GPV
Company: Ascendis Pharma A/S
Location: Palo Alto, CA (On-site)
Salary Range: USD 200,000 - 250,000

Job Description:

Ascendis Pharma is a fast-growing biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology across Denmark, Europe, and the United States. We leverage our TransCon drug development platform to develop best-in-class therapies for unmet medical needs.

The Associate Director, Global Pharmacovigilance (PV) Operations reports to the Head of Global PV Operations and is responsible for overseeing drug safety PV operations across Ascendis' product portfolio.

Key Responsibilities:

Clinical & Study-Related PV Operations:

Act as an active member of Study Management Teams (SMTs) representing PV Operations.
Participate in sponsored and investigator-initiated trials for Ascendis products.
Review and contribute to study-related documents (Study Protocols, Safety Management Plans (SMPs), Data Management Plans).
Support Serious Adverse Event (SAE) reconciliation activities.
Oversee study classification (**interventional, non-interventional, Post Approval Safety Studies (PASS), etc.).

PV Vendor & Service Provider Oversight:

Ensure PV vendors fulfill responsibilities, including Individual Case Safety Reports (ICSR) processing and compliance with global/local regulations.
Provide feedback and guidance on adverse event processing from various sources (spontaneous, solicited, study-related cases).
Identify, develop, and maintain training documents (e.g., SOPs) for targeted audiences.
Advise internal teams (Clinical Development, Medical Affairs, Commercial, PV staff) on PV requirements.

Safety Reporting & Compliance:

Ensure timely and accurate ICSR submissions.
Support preparation of expedited and aggregate safety reports (e.g., 15-day Alert Reports, SUSAR, PSUR, US PADER, DSUR, IND Annual Report).
Monitor compliance with Good Pharmacovigilance Practices (GVP) and Patient Support Programs (PSPs).
Conduct risk assessments, develop compliance strategies, and oversee corrective actions (CAPAs).

Additional Responsibilities:

Represent PV operations during regulatory inspections and audits.
Collaborate with Medical Safety Science for assigned activities.
Ensure Risk Management Plan (RMP) implementation and tracking.
Support crisis management and oversight of Local PV agreements, Customer Relationship Management (CRM), and Digital Media PV activities.

Competencies for Success:

Strong independent and collaborative work ethic.
Excellent organizational, analytical, and strategic decision-making skills.
Effective communication and leadership abilities.
High attention to detail and regulatory compliance.

Minimum Qualifications:

Master’s degree in a healthcare field with 8+ years of Pharmacovigilance experience in the pharmaceutical industry.
Expert knowledge of FDA safety regulations, ICH Guidelines, and global safety regulations.
Ability to travel up to 20% (domestic and international).

Benefits:

401(k) plan with company match
Medical, dental, vision insurance
Life and AD&D insurance
Short & long-term disability benefits
Pet Insurance, Legal Insurance, Employee Assistance Program
Professional Development & Employee Discounts
Health Savings Account (HSA) & Flexible Spending Accounts (FSA)
Various incentive compensation plans
Paid parental leave & mental health resources

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Associate Dean Of Clinical Affairs - Hs Associate / Full Clinical Professor

Job Description

Job Description:

Key Responsibilities:

Clinical & Study-Related PV Operations:

PV Vendor & Service Provider Oversight:

Safety Reporting & Compliance:

Additional Responsibilities:

Competencies for Success:

Minimum Qualifications:

Benefits:

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