Manager Clinical Site Contracts at BlueRock Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Cell Therapy, PharmaceuticalsIndustries

Requirements

Proactive, detail-oriented professional capable of negotiating, drafting, and managing complex agreements in a fast-paced, collaborative environment
Strong knowledge of biotech and pharmaceutical contract types, including Clinical Trial Agreements (CTAs), Confidentiality Disclosure Agreements (CDAs), Master Clinical Trial Agreements (MCTAs), and Consulting Agreements (CA)

Responsibilities

Prepare, review, and negotiate a variety of contracts including CTAs, MCTAs, CDAs, and consulting agreements in compliance with company policies and industry standards
Oversee the end-to-end regional/global site contracting process—from intake and drafting through execution and renewal—ensuring timely delivery and alignment with project and business objectives, with a focus on implementing effective and sustainable processes, templates, and tools
Act as the primary BlueRock communication conduit for all site contracting matters
Identify contractual risks and provide guidance to stakeholders to mitigate exposure while supporting company goals
Work closely with Legal, Clinical Operations, Procurement, Finance, and R&D to ensure contracts reflect appropriate business and risk positions
Create and maintain investigational grants financial benchmarks for assigned clinical trials
Drive alignment for financial negotiation parameters and manage financial escalations when applicable to ensure compliance adherence
Work closely with Finance and Operations stakeholders to establish study/project forecasts and manage relevant financial tracking and accruals/review invoices
Ensure adherence to time-based site payment disbursement goals
Support Purchase Order generation and management
Support/manage process improvement efforts, including adherence to BRT standards and all applicable regulations and guidelines
Review/develop business terms, BRT Working Practices, Standard Operating Procedures (SOPs), templates, training, platforms, and systems to drive improvements that are advantageous to BRT
Represent values-based leadership consistent with BRT Core Values: courage, urgency, integrity

Skills

Contract Negotiation

Contract Drafting

Contract Management

Clinical Trial Agreements

Biotech Contracts

Legal Agreements

BlueRock Therapeutics

Develops advanced cellular therapies for diseases

About BlueRock Therapeutics

BlueRock Therapeutics develops advanced cellular therapies using a unique cell gene platform that directs cellular differentiation and genetically engineers cells. This technology allows them to create new types of medicines aimed at treating complex diseases in areas such as neurology, cardiology, and immunology. Their products work by transforming cells to target specific medical conditions, including neurodegenerative diseases, heart failure, and immune disorders. Unlike many competitors, BlueRock focuses on a specialized approach within the rapidly growing field of regenerative medicine, emphasizing strategic partnerships and research and development to advance their therapies. The company's goal is to address challenging medical conditions through innovative cellular treatments and to generate revenue through collaborations, licensing agreements, and eventual commercialization of their therapies.

Cambridge, MassachusettsHeadquarters

2016Year Founded

$218.9MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Hybrid Work Options

Risks

Competition from established firms like Johnson & Johnson may overshadow BlueRock's innovations.

Reliance on strategic partnerships poses risks if partners shift focus or resources.

Regulatory hurdles could delay product launches, impacting revenue and market position.

Differentiation

BlueRock uses iPSC technology to create novel cellular therapies for complex diseases.

Their strategic partnerships enhance R&D capabilities and expand therapeutic applications.

Focus on neurology, cardiology, and immunology addresses challenging medical conditions.

Upsides

FDA RMAT designation for bemdaneprocel accelerates market entry for Parkinson's therapy.

Successful Phase I trial of bemdaneprocel boosts investor confidence and funding potential.

Collaboration with bit.bio enhances discovery and development of new cell therapies.

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