Top 36 Senior director of operations Jobs in Lowell, Ma

Senior Director, Pharmacovigilance (PV) Sciences
Keros Therapeutics —Lexington, MA
- $245,000 - $302,000 a year
- Nursing
- 8 years
- Bachelor of Science in Nursing
Sr. Director, Digital Portfolio and Strategic Operations
Moderna, Inc. —Cambridge, MA
- $196,700 - $353,400 a year
- Full-time
- Bachelor of Science
- Office
- Analysis skills
- Paid time off
- Adoption assistance
Senior Director, Business Operations
Bain & Company Inc —Boston, MA
- $236,000 - $289,250 a year
- Full-time
- Office
- 3 years
- Bachelor's degree
- Wellness program
- Paid holidays
7d
Senior Director, Revenue Operations
Replimune —Woburn, MA
- $221,000 - $286,000 a year
- Full-time
- Hybrid work
- Oracle
- CPA
- Office
- Paid holidays
- Health insurance
Quick Apply
Senior Director of Customer Support Operations
BRUNT Workwear —North Reading, MA
- $139,000 - $165,000 a year
- Office
- Mentoring
- Organizational skills
Senior Director, Business Operations
Bain & Co. —Boston, MA
- $236,000 - $289,250 a year
- Full-time
- Office
- 3 years
- Bachelor's degree
- Wellness program
- Paid holidays
Quick Apply
7d
Senior Director, Strategy and Operations
Flagship Pioneering, Inc. —Cambridge, MA
- $220,000 - $270,000 a year
- 7 years
- Office
- Doctor of Philosophy
- Retirement plan
Senior Director, AI Operations and Services
Dana-Farber Cancer Institute —Boston, MA
- $243,000 - $257,400 a year
- Full-time
- Azure
- HIPAA
- Master's degree
Senior Director of Operations
M/A Com Technolgy Solutions —Nashua, NH
- Engineering
- 11+ years
- Manufacturing
- Dental insurance
- 401(k)
8d
Senior Director, SPARC Plant Operations
Commonwealth Fusion Systems —Devens, MA
- $250,000 - $350,000 a year
- Weekends as needed
- 11+ years
- Travel
- Mentoring
- Dental insurance
- Parental leave
Quick Apply
Senior Director, Global Operations Digital Transformation (Hybrid - Acton, MA)
Insulet Corporation —Acton, MA
- $204,500 - $306,725 a year
- Full-time
- Hybrid work
- Engineering
- 11+ years
- Office
- Health insurance
- Dental insurance
Senior Director of Operations
BAE Systems Inc. —Hudson, NH
- $173,023 - $294,137 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Mentoring
- Health savings account
- Paid holidays
13d
Senior Director, Clinical Operations
Kymera Therapeutics —Watertown, MA
- $235,000 - $330,000 a year
- Bachelor of Science
- 11+ years
- Bachelor's degree
Quick Apply
Senior Director, Legal Operations and Chief of Staff to CLO
Mass General Brigham Incorporated —Somerville, MA
- $161,657.60 - $235,154.40 a year
- Full-time
- Hybrid work
- 5 years
- Office
- Bachelor's degree
- Opportunities for advancement
Quick Apply
14d
Director/Senior Director, IT Operations and Governance
Crescent Biopharma —Waltham, MA
- $220,000 - $260,000 a year
- Full-time
- Analysis skills
- Senior level
- Leadership
- Paid holidays
- Disability insurance
Quick Apply
8d
Senior Director, Regional Business Operations Director
WSP —Boston, MA
- $175,000 - $352,000 a year
- 11+ years
- Office
- Master's degree
- Paid parental leave
- Disability insurance
2d
Senior Director Corporate Strategy and Operations
Flagship Pioneering, Inc. —Cambridge, MA
- $217,000 - $275,000 a year
- 7 years
- Analysis skills
- Bachelor's degree
- Retirement plan
Quick Apply
Senior Director, Clinical Operations
Alira Health —Boston, MA
- $175,000 - $195,000 a year
- Full-time
- Medicine
- Bachelor of Science
- English
Senior Director, Portfolio & Program Management
Vertex Pharmaceuticals —Boston, MA
- $242,200 - $363,200 a year
- Full-time
- Hybrid work
- 5 years
- Writing skills
- Bachelor's degree
- Loan repayment program
- Health insurance
Director/Sr. Director, Clinical Operations Lead
Paratus Sciences Corporation —Boston, MA
- $180,000 - $275,000 a year
- Full-time
- Hybrid work
- Nursing
- Bachelor of Science
- Office
Quick Apply
9d

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Senior Director, Pharmacovigilance (PV) Sciences

Keros Therapeutics -
Lexington, MA

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Job Details

$245,000 - $302,000 a year

Qualifications

Medical writing
Pharmacovigilance research
Pharmaceutical company experience

Full Job Description

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

Job Summary:

The Senior Director, Pharmacovigilance (PV) Sciences serves as the vital bridge between scientific strategy and operational drug safety for the company's early-stage and clinical pipeline. In this hybrid, hands-on role, you will be responsible for both strategic safety science and daily PV operations. You will report directly to the Vice President, Head of Clinical Development & Operations (a former PV physician and Head of Drug Safety).

The Senior Director, Pharmacovigilance (PV) Sciences partners with PV physicians, other clinical development colleagues, and PV vendors, and will contribute to safety deliverables required to manage and communicate the evolving safety profile of Keros products. The Senior Director, PV Sciences is responsible for safety surveillance and aggregate safety reports and works with PV physicians for signal/risk management for Keros products to support product safety and compliance with global drug safety regulations and functional procedures and provide vendor oversight to PV vendors. The individual authors safety documents, reviews safety sections of other documents for Keros products throughout the product lifecycle, performs QC and maintains document control of safety documents. This individual will organize cross-functional Safety Management Team meetings and collaborate with colleagues in Clinical Development, Clinical Pharmacology, Biometrics, Regulatory, Medical Affairs, Toxicology and non-clinical safety, QA, and Legal functions. This individual ensures compliance with all applicable US and foreign legal and regulatory requirements for signal detection, evaluation & risk management of products.

Primary Responsibilities:

Serve as the primary liaison with external PV vendors, Contract Research Organizations (CROs), and safety database providers. Ensure database readiness and compliance with global regulatory guidelines
Develop scalable PV systems and processes as the company transitions its clinical pipeline
Proactively establish and maintain inspection readiness for Health Authority audits
Lead proactive signal detection, evaluation, management, author safety signal assessment reports, write and maintain relevant SOPs and procedures in compliance with global safety regulations and guidelines, and provide training within DSPV and cross-functionally
Lead and manage all medical safety and risk management related projects including planning, tracking and execution; provide vendor oversight for quality of ICSRs, similar case analysis, and aggregate safety reporting; lead initiatives from the scientific and PV regulation perspective such as inspection readiness, and launch readiness
Organize and facilitate cross-functional Safety Management Team (SMT) meetings for signal management, risk management detection, and benefit-risk assessment for Keros products, prepare the meeting minutes, and track actions
Spearhead the planning, writing, and review of key periodic and aggregate safety reports
Review safety concerns escalated from internal and external stakeholders, including competent Regulatory Authorities, and develop strategies for safety assessment in collaboration with PV physicians
Provide scientific and medical input into clinical documents such as Protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs) and responses to ad-hoc requests for safety information internally and externally
Tailor benefit-risk assessments and risk mitigation strategies to the specific physiological, developmental, and regulatory realities of pediatric populations
Schedule meetings for safety teams, clinical teams and vendors for follow-up queries and company causality assessment for SAEs, pregnancy and special cases in clinical trials
Perform QC (quality control) for multiple tasks and data reconciliation of between the Clinical and the Safety Database
Provide strategic safety contributions to regulatory submissions (e.g., INDs, eventual NDAs/BLAs).
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
Other duties as assigned

Qualifications:

Health Care Professional degree required (e.g., RN/BSN/MSN, NP, PharmD) and 8-10+ years of pharmaceutical industry experience in drug safety & pharmacovigilance as a Safety Scientist for products in the clinical trial and post-marketing environments
Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
Excellent verbal and written communication skills with ability to write clearly and concisely, and strong presentation skills
Ability to be flexible, adapt to change, work independently, as well as experience working in a highly collaborative matrix environment
Time management skills with ability to prioritize meeting required deadlines

Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Recruitment & Staffing Agencies:
Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.

Apply Now

Refine Your Search

senior director of operations jobs in lowell, ma

Senior Director, Pharmacovigilance (PV) Sciences

Sr. Director, Digital Portfolio and Strategic Operations

Senior Director, Business Operations

Senior Director, Revenue Operations

Senior Director of Customer Support Operations

Senior Director, Business Operations

Senior Director, Strategy and Operations

Senior Director, AI Operations and Services

Senior Director of Operations

Senior Director, SPARC Plant Operations

Senior Director, Global Operations Digital Transformation (Hybrid - Acton, MA)

Senior Director of Operations

Senior Director, Clinical Operations

Senior Director, Legal Operations and Chief of Staff to CLO

Director/Senior Director, IT Operations and Governance

Senior Director, Regional Business Operations Director

Senior Director Corporate Strategy and Operations

Senior Director, Clinical Operations

Senior Director, Portfolio & Program Management

Director/Sr. Director, Clinical Operations Lead

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