Sr. Clinical Project Manager (Sr. CPM)

Zydus Therapeutics Inc.•Hopewell Township, NJ

117d•Onsite

About The Position

SUMMARY: Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. Zydus Therapeutics, Inc. is seeking a candidate for the role of Senior Clinical Project Manager (Sr. CPM) is responsible for the planning, execution, and oversight of clinical trials across multiple phases, ensuring compliance with regulatory requirements, timelines, and budget constraints. This role involves cross-functional team leadership, vendor management, and collaboration with key stakeholders, including investigators, regulatory agencies, and internal teams. The Sr. CPM will play a pivotal role in driving operational excellence in clinical trial execution.

Requirements

Strong leadership, communication, and negotiation skills.
Ability to work in a fast-paced environment and manage multiple priorities.
Proficiency in clinical trial management systems (CTMS), EDC, and regulatory submission platforms.
Excellent problem-solving and risk management abilities.
Financial acumen for budget forecasting and cost control.
Bachelor’s degree in life sciences, pharmacy, nursing, or a related field (Master’s or PhD preferred).
7+ years of experience in clinical trial management within the pharmaceutical, biotech, or CRO industry.
Proven experience in leading Phase I-IV clinical trials.
Strong understanding of GCP, ICH guidelines, FDA, EMA, and other regulatory requirements.
Experience managing CROs, vendors, and multi-site global trials.

Nice To Haves

Prior experience in neurology, rare diseases is a plus.
Experience working in an FDA-regulated and/or EMA-regulated environment.
Knowledge of adaptive trial designs and decentralized clinical trials is an advantage.

Responsibilities

Lead end to end clinical trial management from protocol development to study closeout.
Develop and maintain detailed project plans, timelines and budgets.
Collaborate with regulatory teams for submissions, amendments, and compliance-related documentation.
Address protocol deviations, audit findings and inspection readiness.
Select, negotiate and mange relationships with CROs, central labs and other external vendors.
Track performance metrics and ensure service level agreements are met.
Proactively identify study risks and develop mitigation strategies.
Address operational challenges, protocol deviations and recruitment/retention issues
Ensure efficient resource allocation to optimize study costs.
Monitor trial related invoices and payments in collaboration with finance teams.
Act as primary point of contact for all internal and external stakeholders.
Provide leadership and mentorship to junior project managers, CRAs and study coordinators.
Foster collaboration among cross functional teams, including Clinical Operations, Data Management, Medical Writing, Quality Assurance and Quality Control, Legal, Finance, and Senior Leadership, as well as external partners (CROs, Laboratories, Specialty service-providers, Investigators).
Ensure high quality data collection and adherence to data integrity standards.
Work closely with data management and biostatistics teams to ensure timely database locks.
Provide regular study updates to senior leadership and stakeholders.
Develop strategies to optimize patient recruitment and retention.
Oversee site relationships, investigator engagement and performance metrics.
Support protocol development and feasibility assessments.
Contribute to clinical development plans, study endpoints and operational feasibility considerations.
Contribute to developing the organizational systems, including development of the SOPs, document management system and project finance management.
Ensure compliance to regulatory requirements/ standard operating procedures and timely management of project activities.
Any other duties as assigned by Supervisor.