Associate Director, Program Safety Lead (MD) - Job ID: 1908
Palo Alto, California, United States · Hybrid
$220k–$235k/yr
Senior$1.9B raised
Are you passionate about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to champion safety excellence, drive compl…
Skills: Pharmacovigilance, Signal Detection, Risk Management, Safety Surveillance, Endocrinology
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Associate Director, Program Safety Lead (MD) - Job ID: 1908
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$220k–$235k/yr
Full-time
postgraduate degree
401(k) Plan With Company Match, Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Accidental Death & Dismemberment Insurance
Posted 13d ago
~40 hrs/week
Responsibilities
The Program Safety Lead defines and executes the safety strategy for endocrinology products, ensuring global pharmacovigilance compliance. They oversee signal detection, risk management plans, and provide medical input for regulatory safety reports and labeling.
Requirements
Candidates must hold a Medical Doctoral degree and have 6-8 years of industry pharmacovigilance experience, preferably within the Endocrinology therapeutic area. Leadership experience in a matrix organization and proficiency in English are required.
Full job description
Are you passionate about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to champion safety excellence, drive compliance, and shape strategy across our growing portfolio.
We are a dynamic, global biopharmaceutical company headquartered in Denmark with hubs in Palo Alto, CA and Princeton, NJ. Come join us at Ascendis Pharma, where our core values --- Patients, Science & Passion, drive us to deliver best-in-class therapies that address critical unmet needs.
The role
The role of Program Safety Lead is a director level position here at Ascendis and this Lead will report to the Head of Global Medical Safety Science. You will play a pivotal role as the Program Safety Lead and pharmacovigilance expert for the Ascendis’ endocrinology pipeline. As a key member of the Global Patient Safety Organization and cross-functional product teams, you will shape the strategy, set priorities and lead pharmacovigilance activities for assigned products. The Program Safety Lead stewards the product safety profile and drives critical safety-related decisions to support the Ascendis portfolio.
As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
You will:
Define safety strategy for assigned development and marketed products in collaboration with cross-functional teams
Serve as the safety lead for assigned products, providing strategic recommendations and oversight of patient safety activities
Ensure compliance with global pharmacovigilance regulations, including signal detection, evaluation, and risk management
Develop and maintain safety surveillance and risk management plans for drug development programs
Oversee identification and evaluation of safety signals and ensure timely escalation and resolution
Provide medical and safety input for expedited and aggregate safety reports (e.g., SUSARs, PSURs, DSURs, IND Annual Reports)
Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
Collaborate with internal and external stakeholders on pharmacovigilance agreements, audits, and regulatory inspections
Monitor industry best practices and evolving global safety regulations; recommend updates to policies and SOPs
Act as a patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams
Your professional qualifications
You hold a Medical Doctoral degree (or equivalent) – and are proficient in English at a professional level, both written and spoken.
Furthermore, you have:
6-8 years, of industry pharmacovigilance experience in a fast-paced biopharmaceutical company.
Leadership experience within the safety profile of products assigned within a matrix organization
Endocrinology Therapeutic Area experience
Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience is preferred
As a person, you have/are:
A passion for advancing innovative therapies that address unmet medical needs for patients struggling with Rare Endocrine Diseases
Comfortable balancing strategic thinking with hands-on execution and mentoring
Demonstrated ability to navigate uncertainty and adapt quickly to changing priorities
Proven track record delivering results in dynamic, fast-paced settings where clarity evolves over time
Travel: Ability to travel up to 20% of the time domestically and internationally
Office location: This is a hybrid role operating preferably out of Palo Alto, CA; however, we welcome candidates to apply residing near our Princeton, NJ office.
The estimated salary range for this position is $220-235k DOE. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
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
Unique offerings of Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Committed to making a meaningful difference for patients
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2007
Headquarters
Hellerup, Capital Region of Denmark
LinkedIn followers
112,218
Total funding
$1.9B
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.
Offices: Tuborg Boulevard 12, Hellerup, Capital Region of Denmark 2900, DK
EndocrinologyDrug DevelopmentInnovationGlobalization and TransCon TechnologyHealth CareClinical TrialsBiotechnology
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