Manager, Clinical Development

Thyroxine SERB; Conshohocken (Montgomery County); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Vacation, Personal and Sick time

15Paid Company Holidays

Medical, Dental, Vision benefits

Tuition Assistance

Discretionary Bonus Plan

401(k) with company match

Job summary

SERB is seeking a Manager of Clinical Development to lead the end-to-end operation of clinical studies, including budgeting, planning, and CRO/IIS oversight. You will ensure regulatory compliance and maintain vendor relationships within an ambitious portfolio of products across geographies.

The role requires strong leadership, written and verbal communication, and the ability to manage multiple trials and priorities while upholding ethical standards and the company’s medical purpose.

Qualifications

• University degree in a health-related field.
• Minimum of three years direct clinical trial experience in a CRO or research-related organization.
• Experience with in-vitro diagnostic studies would be beneficial.
• EU experience would be beneficial.

Responsibilities

• Manage all aspects for company sponsored and IISs according to SOPs and ensure compliant processes.
• Ensure projects comply with the protocol, GCP, and applicable regulations.
• Supervise outsourced tasks and manage contractor relationships with oversight of vendors.
• Draft study documents such as synopsis, protocols, informed consents and study plans per SOPs.
• Prepare clinical study budget and manage studies to approved budget.
• Ensure regulatory documents are obtained and study files comply with GCP and SOPs.
• Update and draft SOPs as required.
• Negotiate contracts for IISs with legal and sites.
• Maintain current knowledge of FDA regulations, GCP, and ICH Guidelines.
• Maintain high ethical and professional standards in all engagements.
• Carry out additional tasks as required by Line Manager.

Skills

Clinical Development

GCP Knowledge

Budget Management

Vendor Management

Contract Negotiation

Regulatory Knowledge

Education

Bachelor's degree in health-related field

3+ years direct clinical trial experience

Tools

EDC (Electronic Data Capture)

Job description

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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
  Patients are not a concept — they are why we act, especially when time matters most.
  
• Impact focused
  We are agile, entrepreneurial, and disciplined - working smart and learning continuously to deliver results that matter, with the consistency, quality, and trust that critical care demands.
  
• Team powered
  We go the extra mile - together - because our shared commitment drives extraordinary outcomes.

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.

Broad Function

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.

1. 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.
2. Ensure that assigned clinical research projects comply with the clinical protocol, the most recent requirements for Good Clinical Practice (GCP) and other applicable regulations.
3. Supervise outsourced tasks and services and manage contractor relationships ensuring appropriate oversight of vendors is maintained
4. Drafting any necessary study documents such as synopsis, study protocols, informed consents and study plans as per company SOP’s.
5. Prepare clinical study budget and manage clinical study to approved budget.
6. 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.
7. Update and Draft SOP’s as and when required.
8. Work with legal and sites to negotiate contracts for IIS’s.
9. Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
10. 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.
11. Carry out other reasonable additional tasks as required by the Line Manager to support the clinical functions.

Education and Experience:

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.

Previous experience with in-vitro diagnostic studies would be beneficial.

EU experience would be beneficial

Skills and Attributes:

Ability to work confidently work independently and as part of a team.

Knowledge of clinical research process from Phase I through regulatory submission.

Strong communication skills (verbal and written) to express complex ideas.

Experience in contract/timeline management preferred with excellent organizational and interpersonal skills.

Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.

Ability to manage multiple priorities within various clinical trials.

Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.

Ability to set baseline targets, track trends and implement mitigation plans.

Understanding of basic data processing functions, including electronic data capture.

Working knowledge of current ICH GCP guidelines.

Company Benefits

• Vacation, Personal and Sick time
• 15Paid Company Holidays
• Medical, Dental, Vision and other Voluntary benefits
• 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.

Serb Pharmaceuticalis an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.