Director, Clinical Systems and Processes

Compensation

$

Hours Per Week

40

Number Of Positions

1

Job Description

Description

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 Clinical Systems and Processes 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.

Place of Work

Hybrid

Requisition ID

DSQT