• Program Safety Lead, GPS Medical Science - Job ID:

    Ascendis Pharma (Palo Alto, CA)


    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

     

    The estimated salary range for this position is $240-260k. 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.

    Requirements

    Your professional qualifications

     

    You hold a Doctoral degree -- preferably an MD (or equivalent), PhD, PharmD – and are proficient in English at a professional level, both written and spoken.

    Furthermore, you have:

    + Ten 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 out of either Princeton, NJ or Palo Alto, CA

     

    Applications will be evaluated when received, so please apply as soon as possible.

     

    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

    + 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.