Manager, Clinical Development

SERB

6d • Remote

About The Position

SERB is a fast-growing global specialty pharma company designed to address rare and urgent conditions by delivering life-saving medicines when time and complexity leave no room for failure. We operate end-to-end across 100+ countries, ensuring 70+ essential medicines for rare diseases, emergency care, and medical countermeasures reach patients and clinicians with urgency – wherever and whenever they are needed. Shaped over the past 25 years by an entrepreneurial, disruptive spirit, SERB combines the focus and agility of a biotech with the scale, reach, and reliability of a global pharmaceutical company — always grounded in medical purpose, not corporate convention. Our 600+ employees are driven by three core values: Patients first, always; Impact focused; and Team powered. Guided by a clear ambition and a relentless focus on patients, SERB continues to expand through selective, innovative acquisitions, launching new treatments and entering new geographies. Across every step — from integration to delivery — our people act with passion, ownership, and determination to ensure life-saving medicines become available to patients who need them, worldwide. The Manager, Clinical Development is accountable for the overall operation of clinical studies including project planning, budget, resource management and contract research organization contact within the overall context of an approved clinical operational plan for the portfolio of products that are consistent with lifecycle program/company goals. The ideal candidate is to be based on the East Coast.

Requirements

• University degree in a health-related field with a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization.
• Knowledge of clinical research process from Phase I through regulatory submission.
• Working knowledge of current ICH GCP guidelines.

Nice To Haves

• Previous experience with in-vitro diagnostic studies would be beneficial.
• EU experience would be beneficial
• Experience in contract/timeline management preferred with excellent organizational and interpersonal skills.

Responsibilities

• Manage all aspects for company sponsored and investigator-initiated studies (IISs) according to the applicable company Standard Operating Procedures (SOPs) and ensure all managed processes are compliant with internal SOPs and external regulations.
• Ensure that assigned clinical research projects comply with the clinical protocol, the most recent requirements for Good Clinical Practice (GCP) and other applicable regulations.
• Supervise outsourced tasks and services and manage contractor relationships ensuring appropriate oversight of vendors is maintained
• Drafting any necessary study documents such as synopsis, study protocols, informed consents and study plans as per company SOP’s.
• Prepare clinical study budget and manage clinical study to approved budget.
• Ensure that regulatory documents are obtained from study sites and that study files are set up and maintained in accordance with GCP and relevant SOPs.
• Update and Draft SOP’s as and when required.
• Work with legal and sites to negotiate contracts for IIS’s.
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values.
• Carry out other reasonable additional tasks as required by the Line Manager to support the clinical functions.

Benefits

• Vacation, Personal and Sick time
• 15 Paid Company Holidays
• Medical, Dental, Vision and other Voluntary benefits
• Paid Parental Leave
• Tuition Assistance
• Discretionary Bonus Plan
• Competitive 401(k), $1 for $1 up to 6% of pay. The safe harbour match is vested immediately. In addition, SERB also offers a discretionary match of up to 4% of pay which vests 20% a year for 5 years.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level