Top 1000 Senior associate director Jobs in Roxbury Crossing Ma

Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
Oruka Therapeutics —Waltham, MA
- $161,000 - $208,000 a year
- Remote
- Nursing
- 6 years
- Bachelor's degree
Quick Apply
Senior Director, People
CoLab Software —Boston, MA
- Remote
- Senior level
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Senior Director, Cardiology Platform Architecture & Interoperability
Philips —Cambridge, MA
- $212,000 - $360,000 a year
- Full-time
- Computer science
- Computer Science
- System design
- Health savings account
- Employee stock purchase plan
Associate Director of Development
Charles River Center —Needham, MA
- $85,000 - $90,000 a year
- Full-time
- Experience working with individuals with disabilities
- 5 years
- Bachelor's degree
Associate Director, Global Regulatory Affairs - Ad / Promo
BioNTech AG —Cambridge, MA
- $166,000 - $203,000 a year
- Full-time
- Background check
- Bachelor of Science
- 8 years
Associate Executive Director - Corporate Compliance Officer
North Charles Mental Health Research and Training Foundation, Inc —Cambridge, MA
- $73,000 - $80,000 a year
- Full-time
- HIPAA
- Office
- Master's degree
- Health savings account
- Health insurance
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Business Office Director (Senior Living)
The Enclave of Franklin —Franklin, MA
- $68,000 - $70,000 a year
- Online Application
- CPR Certification
- Microsoft Outlook
- Mid-level
- Health savings account
- Health insurance
Quick Apply
23h
Associate Director of Operations
Tenacity —Allston, MA
- $65,000 - $75,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Background check
- Microsoft Excel
- Health insurance
- Dental insurance
Quick Apply
Associate Director
Lappin Foundation —Beverly, MA
- $120,000 - $140,000 a year
- Weekends as needed
- Background check
- 5 years
- Office
- Health insurance
- Dental insurance
Quick Apply
3d
Associate Director of Business Development - Southern West Coast (Biotech Services)
Coriolis Pharma Research GmbH —Boston, MA
- Up to 50% travel
- Customer service
- 5 years
Quick Apply
11d
Senior Director Process Excellence - Global Business Services
Cabot Corporation —Billerica, MA
- $228,700 - $331,600 a year
- Full-time
- Hybrid work
- Background check
- Oracle
- Pass drug screening
- Health insurance
- Benefits from day one
Associate Director of Business Development - Northeast US (Biotech Services)
Coriolis Pharma Research GmbH —Boston, MA
- Up to 50% travel
- Customer service
- 5 years
Quick Apply
11d
Senior Director, Global Inspection Management
Ultragenyx Pharmaceutical —Bedford, MA
- $241,400 - $298,200 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Children
- Gym membership
Senior Director, Drug Safety & Pharmacovigilance – Development
Klein Hersh International —Boston, MA
- Email
- Medicine
- 5 years
- Contracts
Associate Director, Medical Writing Science (Temp-to-Perm)
Lenox Executive Search —Boston, MA
- $80 - $95 an hour
- Contract
- Hybrid work
- Background check
- Office
- Supervising experience
Quick Apply
3d
Senior Director, Data Engineering
Global Partners —Newton, MA
- $182,300 - $291,500 a year
- Full-time
- Computer Science
- System design
- 11+ years
- Health insurance
- Dental insurance
Quick Apply
Director of Sales and Community Relations for Senior Living
Arbors at Stoneham —Stoneham, MA
- Weekends as needed
- Marketing
- Residential
- Business development
Quick Apply
Associate Director, Clinical Assay Strategy, Flu
CSL Seqirus —Waltham, MA
- $179,000 - $212,000 a year
- Full-time
- Hybrid work
- Office
- Bachelor's degree
- Doctor of Philosophy
Associate Director, Global Inspection Management
Ultragenyx Pharmaceutical —Bedford, MA
- $179,600 - $221,900 a year
- Hybrid work
- 11+ years
- Bachelor's degree
- Children
- Gym membership
Child Care Associate Center Director
BrightPath Kids USA —Canton, MA
- Full-time
- Customer service
- Mid-level
- Associate's degree
- Health insurance
- Dental insurance
Quick Apply

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Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

Oruka Therapeutics
Waltham, MA

Quick Apply

Job Details

$161,000 - $208,000 a year

Qualifications

Employee relationship building
ICH guidelines
Bachelor's degree
Pharmaceutical company experience
Managing clinical research teams
Vendor performance improvement
Vendor relationship management
Communication with regulatory authorities for clinical trials
Clinical quality assurance standards
FDA regulations

Full Job Description

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Sr. Manager/Associate Director, Clinical Monitoring Strategy and Optimization

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview:

We are seeking an experienced and highly motivated Sr. Manager/Associate Director of Clinical Monitoring Strategy and Optimization to provide strategic and operational leadership for clinical monitoring activities across our development programs. This individual will play a critical role in building and scaling clinical operations infrastructure within a fast-paced emerging biotech environment.

The successful candidate will oversee CRO monitoring performance, ensure high-quality execution of clinical trials, and contribute to the development of monitoring processes, vendor oversight strategies, and inspection readiness activities. This role requires a hands-on leader who is comfortable operating both strategically and tactically in a lean organization.

Key Responsibilities:

Clinical Monitoring Leadership

Lead and oversee clinical monitoring activities for Phase 1–3 clinical trials conducted globally and/or domestically.
Serve as the internal expert for monitoring strategy, site management, and risk-based monitoring approaches.
Provide oversight and management of CROs, CRAs, and other external vendors to ensure quality, timelines, and budget adherence.
Review monitoring plans, trip reports, metrics, and monitoring deliverables for quality and compliance.
Partner cross-functionally with Clinical Development, Clinical Science, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Vendor and CRO Oversight

Establish effective CRO oversight and governance processes.
Monitor CRO performance through KPIs, metrics, and regular operational reviews.
Escalate and resolve study conduct issues proactively.
Participate in vendor selection, qualification, and contract review activities.

Trial Execution and Compliance

Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations.
Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans.
Contribute to inspection readiness activities and support regulatory inspections and audits.

Operational Process Development

Help build scalable clinical monitoring infrastructure appropriate for a growing biotech company.
Develop and refine SOPs, work instructions, templates, and monitoring processes.
Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.
Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate.

Team Leadership and Mentorship

May directly manage CRAs and/or Clinical Trial Managers as the organization grows.
Mentor junior clinical operations staff and contribute to team development.
Foster a collaborative, accountable, and quality-focused culture.

Qualifications:

Required

Bachelor's degree in life sciences, nursing, or related discipline.
6-8+ years of clinical operations experience within biotech, pharmaceutical, or CRO environments.
Significant experience overseeing clinical monitoring activities in interventional clinical trials.
Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
Experience managing CROs and external vendors.
Demonstrated ability to work effectively in a small, fast-moving biotech environment.
Excellent communication, organizational, and problem-solving skills.
Extensive domestic and international travel as needed (approximately 60-80%).

Preferred

Bachelor's degree or equivalent required.
Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred.
Experience in rare disease, immunology, oncology, or other relevant therapeutic areas.
Experience supporting NDA/BLA-enabling studies and regulatory inspections.
Experience implementing risk-based monitoring strategies and oversight models.
Prior people management experience.

Desired Leadership Competencies

Strategic thinker with strong execution skills
Comfortable with ambiguity and rapid change
Hands-on and solutions-oriented
Strong collaborator and relationship builder
High attention to detail and commitment to quality
Ability to influence cross-functional teams and external partners

Compensation:

An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
The anticipated salary range for Sr. Manager is $161,000 - $187,000 and for Associate Director level is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day

What We Offer:

A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
Competitive salary and benefits package.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.

Quick Apply

Refine Your Search

senior associate director jobs in roxbury crossing ma

Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

Senior Director, People

Senior Director, Cardiology Platform Architecture & Interoperability

Associate Director of Development

Associate Director, Global Regulatory Affairs - Ad / Promo

Associate Executive Director - Corporate Compliance Officer

Business Office Director (Senior Living)

Associate Director of Operations

Associate Director

Associate Director of Business Development - Southern West Coast (Biotech Services)

Senior Director Process Excellence - Global Business Services

Associate Director of Business Development - Northeast US (Biotech Services)

Senior Director, Global Inspection Management

Senior Director, Drug Safety & Pharmacovigilance – Development

Associate Director, Medical Writing Science (Temp-to-Perm)

Senior Director, Data Engineering

Director of Sales and Community Relations for Senior Living

Associate Director, Clinical Assay Strategy, Flu

Associate Director, Global Inspection Management

Child Care Associate Center Director

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