Cogentbio
Manager/Senior Manager, Clinical Outsourcing
Cogentbio, Boulder, Colorado, United States, 80301
Who We Are
Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
Our Team
https://cogent.culturehq.com
The Manager/Sr. Manager, Clinical Outsourcing role will be responsible for the entire clinical outsourcing lifecycle, including service provider identification, RFI, RFP, service provider evaluation & selection, contract & budget negotiation, performance monitoring, change orders management, and contract closeout.
Responsibilities
Establishes and cultivates effective internal and external partnerships, managing the evolution of clinical vendor partnerships through their life cycles, including proposal solicitation, negotiation of contractual agreements/amendments, governance, and issue escalation. Work cross-functionally to maximize the value from clinical vendors to meet business objectives and identify and implement efficiencies. In partnership with Legal, the candidate will facilitate the negotiation of clinical study agreements and ancillary documents with investigative sites in support of global clinical trials with minimal oversight. Oversee development and negotiation of investigator site budgets for all markets. In Collaboration with Finance and Clinical Operations, maintain project-level financial management, including budgeting and monthly forecasting and accruals. Establish and maintain key vendor oversight plans and processes (e.g., Clinical Study Oversight Plan, Risk-Based Monitoring processes, etc.) Monitor the outsourcing environment to keep current on providers and industry trends. Identify areas for improvement, as well as support development and updates to existing processes, tools, and templates. Qualifications
A minimum of 3+ years of experience in clinical contracts and/or clinical outsourcing within the bio-pharmaceutical industry or from a contract research organization or other relevant providers; 5+ years of experience for Sr. Manager role. Knowledge of clinical research process and regulatory environment. Proficient in the end-to-end clinical outsourcing and contracting processes. Demonstrates business/financial acumen for analyzing and negotiating complex budgets with CROs, Central Labs, eCOA, Imaging, PK, and Biomarker service providers. Experience with working in a matrixed business environment, handling multiple commitments and stakeholders while prioritizing conflicting demands, maintaining focus on the objective, and providing high quality service to both internal and external collaborators. Strong strategizing, managing, planning, scheduling, and analytical skills. Self-motivated and demonstrated success in working with cross-functional teams. $136,000 - $185,000 a year
Target Bonus -15%
Exact compensation may vary based on skills, experience, and location.
Our Locations Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building. Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization. Our Offer To You To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits. We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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Establishes and cultivates effective internal and external partnerships, managing the evolution of clinical vendor partnerships through their life cycles, including proposal solicitation, negotiation of contractual agreements/amendments, governance, and issue escalation. Work cross-functionally to maximize the value from clinical vendors to meet business objectives and identify and implement efficiencies. In partnership with Legal, the candidate will facilitate the negotiation of clinical study agreements and ancillary documents with investigative sites in support of global clinical trials with minimal oversight. Oversee development and negotiation of investigator site budgets for all markets. In Collaboration with Finance and Clinical Operations, maintain project-level financial management, including budgeting and monthly forecasting and accruals. Establish and maintain key vendor oversight plans and processes (e.g., Clinical Study Oversight Plan, Risk-Based Monitoring processes, etc.) Monitor the outsourcing environment to keep current on providers and industry trends. Identify areas for improvement, as well as support development and updates to existing processes, tools, and templates. Qualifications
A minimum of 3+ years of experience in clinical contracts and/or clinical outsourcing within the bio-pharmaceutical industry or from a contract research organization or other relevant providers; 5+ years of experience for Sr. Manager role. Knowledge of clinical research process and regulatory environment. Proficient in the end-to-end clinical outsourcing and contracting processes. Demonstrates business/financial acumen for analyzing and negotiating complex budgets with CROs, Central Labs, eCOA, Imaging, PK, and Biomarker service providers. Experience with working in a matrixed business environment, handling multiple commitments and stakeholders while prioritizing conflicting demands, maintaining focus on the objective, and providing high quality service to both internal and external collaborators. Strong strategizing, managing, planning, scheduling, and analytical skills. Self-motivated and demonstrated success in working with cross-functional teams. $136,000 - $185,000 a year
Target Bonus -15%
Exact compensation may vary based on skills, experience, and location.
Our Locations Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building. Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization. Our Offer To You To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits. We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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