Senior Clinical Project Manager

Senior Clinical Project Manager

About Pharming

Pharming Healthcare Inc. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands.

Our Vision

Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.

Life at Pharming

Today, more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together.

Summary

The Senior Clinical Project Manager (Sr. CPM) is responsible to plan, initiate, execute and report assigned clinical studies in accordance with the study protocol, ICH-GCP guidelines, SOP's and other relevant laws and regulations. The Sr. CPM selects, guides, and supervises third party vendors and defines budgets, timelines, and resources for the assigned clinical studies. The person in this position implements effective training and guidance of study team interactions, study sites and external contributors throughout the course of a trial. This needs to be executed in close cooperation and transparent communication with cross-functional teams such as: Clinical study team, Pharmacovigilance, Supply Chain, Regulatory Affairs, Quality Assurance - requiring a huge ability to coordinate multiple, parallel processes in order to oversee and control a successful course.

Responsibilities

Clinical Studies

• Coordinate with cross-functional teams during the clinical study development phase to ensure there are appropriate internal resources, IMP and sufficient budget for the conduct of the clinical study

• Oversee project level operational aspects of the clinical study, including development and management of study timelines, budget and deliverables

• Lead the selection, contracting and budget negotiations of CROs, other third-party vendors and clinical trial sites

• Plan and implement the development of essential study documents (e.g. study protocol, SAP, ICF, etc.) and manage the review by in- and external teams

• Oversee the preparation of regulatory submissions to the IRB/EC (local/ central) and national health authority(ies) for the assigned studies

• Provide direction to study team members with a support role (CPCs and CTAs)

• Monitor and track project progress to proactively identify risks to study timelines and budget, mitigation strategies and mitigate risks by implementing appropriate corrective and preventive actions, escalating as necessary

• Ensure adequate oversight and management of clinical study sites by the CRO/monitors

• Oversee process and aspects of timely data cleaning, data analysis and the reporting of headline results, manage and contribute to the data review process, tables/listing/figures review and development of the CSR

• Proactively identify any issues or risks for the assigned studies and implement appropriate action and escalation of the issues

• Ensure appropriate procedures are in place for timely reporting and adequate follow-up of SAEs to PHV, and subsequently to the authorities

Other Responsibilities

• Provide leadership, direction, and motivation to project team members, to promote their professional development

• Prepare updates for senior leadership on the progress of study timelines/milestones, budget and resources, and summarize associated risks and risk mitigation plans

• Provide updates and information related to assigned clinical stud(ies) to cross- functional departments, as needed (i.e. to PHV for periodic safety reports)

• Participate in process improvement and quality related initiatives, such as review and/ or provide input and/ or write departmental SOPs, templates and forms

Qualifications

• Bachelor's degree or higher in a scientific or medical field preferred; work experience can be considered in lieu of degree

• At least five years of experience in sponsor-side Clinical Project Management roles at small-to-mid sized biotech/pharma companies

• At least two years of experience with global clinical trials

• In depth knowledge of ICH-GCP and regulatory requirements

• Ability to work across multiple time zones, including Europe

• Strong knowledge of protocol and clinical drug development processes, monitoring, clinical study planning, conduct and management

• Requires project management skills and study leadership ability

• Must have excellent interpersonal, written and verbal communication skills

• Excellent time management skills

Salary Range

Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.

The base salary range for this role is from $145,000-$180,000 per year.

Compensation & Benefits

• A fully remote work schedule

• Competitive compensation package including annual target bonus

• Long-term incentive program

• 401(k) plan with company match

• Paid Time Off (PTO)

• 13 Company Holidays per year

Other Benefits

• Excellent benefit plans including medical, dental, and vision

• Flexible spending accounts

• Company-provided life insurance, short-term disability, and long-term disability plans

• Optional accident, hospital indemnity, critical illness, and pet insurance plans

• Tuition reimbursement program

• Health and wellness program

• Choice of company provided mobile phone or cell phone stipend

Additional Information

Pharming Healthcare, Inc. is a merit-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to [email protected] .

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.