Associate Director, Study Manager, Immunology

Socket.dev; North Wales (Montgomery County); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Retirement benefits

Paid time off

Job summary

Socket.dev is seeking an experienced Clinical Trial Lead to drive operational planning and execution of one or more clinical trials in our program. You will lead a global, cross-functional team and mentor junior staff, building capabilities in project management, communication, and collaboration in support of clinical trials.

The role requires strong knowledge of GCP/ICH, ability to manage multiple priorities, and experience in protocol development and study governance.

Qualifications

• Bachelor's degree with 9+ years in pharmaceutical, clinical drug development, or medical field experience
• Master's degree with 6+ years in pharmaceutical, clinical drug development, or medical field experience
• PhD/PharmD with 2+ years in pharmaceutical, clinical drug development, or medical field experience
• Degree in life sciences preferred

Responsibilities

• Lead operational planning, feasibility, execution and conduct of clinical trial(s)
• Serve as the Clinical Trial Team lead
• Direct teams in study planning, governance and issue escalation/mitigations
• Collaborate with internal/external stakeholders to support trial objectives
• Liaise with partners, vendors, and vendor management teams
• Review clinical documents for input on protocols and related materials
• Build talent and coach junior team members; manage resources and performance

Skills

Clinical operations

Leadership

Regulatory knowledge

Project management

Stakeholder management

Communication skills

Problem solving

Microsoft Office

Education

Bachelor's Degree

Master's Degree

PhD/PharmD

Life sciences preferred

Job description

Job Description

This position participates in the strategy and leads the operational planning and execution of one or more clinical trials in our Tulisokibart program. In this position, you will have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross‑functional team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.

Job Responsibilities

• Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s)
• Serves as the Clinical Trial Team lead
• Leads and directs teams in key study planning, development, and execution elements (e.g. operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance)
• Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives
• Liaises with partners, vendors, and vendor management team
• Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate
• May serve as a subject matter expert and/or participate on process improvement teams
• Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities
• May include management of direct/ indirect reports including assignment of resources, professional development, and performance management

Core Skills

• Demonstrated ability to drive and manage scientific activities on clinical protocols
• This position may represent the company through external partnerships, collaborations, and key strategic engagements
• Strong knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH))
• Proven ability to manage competing priorities and effectively delegate and assign activities to meet the business needs
• Ability to develop short and mid‑range project plans that are realistic and effective at meeting goals
• Strong analytical skills to drive operational milestones

• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
• Interact with key stakeholders across department, division, and company. Roles requires a proactive approach, strategic thinking and leadership driving toward study goals
• Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Strong communication, writing, and presentation skills
• Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Education/Experience

• Bachelor's Degree and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
• Master's Degree and 6+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
• PhD/PharmD Degree and 2+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Degree in life sciences, preferred

Ideal candidate would have:

• Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders
• Experience in conducting global clinical trials, including trial initiation through database lock
• Experience in managing and driving operational activities on protocols for immunology related clinical trials

Required Skills:

Adaptability, Analytical Problem Solving, Clinical Development, Clinical Operations, Clinical Sciences, Conflict Management, Critical Thinking, Ethical Standards, Good Clinical Practice (GCP), Partner Relationship Management (PRM), People Management, Presentation Delivery, Process Improvements, Stakeholder Alignment, Strategic Thinking

Preferred Skills:

Leadership, Prioritization, Problem Solving, Study Management, Vendor Management

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status:

Regular

Relocation:

No

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

The salary range for this role is $142,400.00 - $224,100.00

The lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.