Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
The Director of Systems, Quality, and Training supports the Clinical Development team and collaborates closely with our partner functions to ensure robust processes that are compliant, fit-for-purpose, efficient and make sense within the broader framework.
Key Responsibilities
Maintains an overview of systems and processes relevant to Clinical Development, and how they interface with each other
- Continuously monitors existing systems and processes relevant to Clinical Development to determine the need for changes to Standard Operating Procedures (SOPs); coordinates updates to existing documents and initiates new documents as appropriate
- Analyzes and refines how systems and processes interface with and feed into each other across the lifecycle of a molecule (eg document templates; data collection, review, and delivery; data analysis and reporting; managing vendors)
- Promotes consistency and efficiency across teams and program
- Serves as a Super User for Veeva and illuminate on the Clinical Development team
- Acts as TMF Ambassador for Clinical Development
- Liaises with IT as appropriate on behalf of Clinical Development
Serves as the Clinical Development representative for ensuring quality within our processes and strategies
- Provides expert advice to identify, manage, and mitigate risk in our clinical trials and our clinical development strategy
- Promotes quality-by-design from study conception and protocol design, study start-up, trial conduct, through reporting on study results
- Promotes a quality culture and coordinates inspection readiness activities (including maintaining the eTMF and other documentation) throughout the clinical trial process
- Partners with SMEs to mitigate identified risks
- Collaborates with subject matter experts and senior management to formulate responses to audit and inspection findings
- Coordinates and supports preparation, review, and finalization of deviations, investigations, root cause analyses, corrective/preventative actions, and change controls
- Catalogues, tracks, reviews, and analyzes audit, inspection, and quality event data to identify trends and areas of exposure
- Acts as Clinical Development SME on MER (Monitoring of External Requirements)
- Stays current on GCP, industry trends, practices, and regulatory guidelines and assesses impact to processes and systems relevant to Clinical Development,
- Partners cross-functionally to determine GxP best practices and drive continuous improvements within processes and systems relevant to Clinical Development
- Provides guidance on interpretation and application of specified regulations to Clinical Development
Optimizes training for Clinical Development based on the team's roles and in terms of timing of trainings
- Ensures a feedback loop between outcomes and our processes/systems and training
- Partners to direct training on SOPs to ensure compliance with regulatory requirements
- Arranges appropriate event-related training, e.g., for audits & inspections, system training for newly implemented/upgraded systems
- Acts as Cornerstone Learning Administrator for Clinical Development
- Ensures appropriate and adequate training documentation
Requirements
- Bachelors degree required. Advanced clinical/science degree preferred (e.g., PhD, PharmD, MSN, MPH)
- 10+ years of industry experience in related role
- Experience in global GCP regulations and quality systems management, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programs
- Experience in regulatory inspections (preparation and follow up)
- Analysis and decision-making based on sound risk-based judgment
- Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
- Ability to speak effectively and communicate directly with cross-functional colleagues in a positive/constructive and collaborative manner
- Possesses excellent communication skills, both verbal and written, and ability to write clearly and concisely
- Strong self-motivation, ability to work independently as well as in a team environment
- Proficient knowledge of Veeva and Cornerstone is desirable
- Ability and willingness to travel approximately 10-15% of the time, domestically and internationally
The estimated salary range for this position is $210-225K/year. 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.
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
Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.
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.
Skills Required
- Bachelor's degree
- Advanced clinical or science degree such as PhD, PharmD, MSN, or MPH
- 10+ years of industry experience in a related role
- Experience with global GCP regulations and quality systems management
- Experience establishing and tracking metrics
- Experience developing and maintaining SOPs and training programs
- Experience preparing for and following up on regulatory inspections
- Risk-based analysis and decision-making skills
- Ability to manage multiple projects and prioritize tasks in a dynamic environment
- Effective cross-functional communication skills
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively
- Proficiency with Veeva and Cornerstone
- Ability and willingness to travel approximately 10-15% domestically and internationally
What We Do
Ascendis Pharma is applying its innovative TransCon technologies to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, Palo Alto and Redwood City, California, and Princeton, New Jersey.
