Jobs - Mersana

Senior Clinical Program Manager

Please check back often for new openings.

Our benefits include:

Medical insurance
Dental insurance
Life/AD&D insurance
Long-term disability insurance
401(k) plan
11 paid holidays
15 vacation days

Please send your resume to careers@mersana.com or

Mersana Therapeutics, Inc.

Attn: Human Resources

840 Memorial Drive

Cambridge, MA 02139

NO PHONE CALLS PLEASE.
Mersana Therapeutics, Inc. is an equal opportunity employer.

Senior Clinical Program Manager - (reference code: SCMP)

November 24, 2009

Mersana Therapeutics employs its biodegradable polymer platform (Fleximer^®) to create new and better medicines. We are advancing our own clinical-stage pipeline of novel compounds with the potential to address multiple oncology indications. We also leverage the versatility of Fleximer through partnerships to overcome the safety, efficacy, and delivery challenges of nucleic acids, biologics, and small molecules in numerous therapeutic areas.

We are seeking an experienced, enthusiastic project leader who thrives in a fast-paced work environment and who will become an integral member of our Clinical Development group. Reporting to the Chief Medical Officer, the Senior Clinical Program Manager's primary function is to lead the management of the operational aspects of clinical programs. The Senior Clinical Program Manager has the experience to execute a clinical plan for an oncology drug development candidate so that compounds are developed in a manner that is timely, within budget, and to a high medical and scientific standard.

Specific Responsibilities:

Maintains a daily, "hands-on" approach to the management of the external vendors, CROs, and clinical sites - supporting site budget negotiations and investigator contracting, site initiation, tracking patient enrollment, site monitoring, and site close-out.
Manages the planning, tracking and adherence to allocated budget and timelines.
Resolves issues affecting clinical program and operations; plans contingencies for potential concerns.
Contributes to the development and review of protocols to achieve the aims of the development plan. Collaborates with relevant internal and external (CROs) groups on the initiation and execution of clinical studies.
Works with the Chief Medical Officer and clinical development group, study sites, and CRO to ensure operational feasibility of protocols and programs for successful implementation.
Assists in the preparation of responses to regulatory agencies regarding program development issues.
Adheres to Code of Federal Regulations, ICH Guidelines and all other applicable ethical, regulatory, and clinical standards.
Supports the production of draft regulatory documents and study reports. Ensures medical/scientific quality of the documents and accordance with regulatory guidelines and the overall development strategy.
Contributes to preparation of abstracts, manuscripts, and external presentations.
Remains current in the scientific/clinical knowledge for the compounds under clinical investigation in the company.
Establishes and fosters an atmosphere conducive to teamwork within the company and with outside project participants.

Other requirements:

Working knowledge of GCPs, ICH Guidelines, and federal regulations
Knowledge of clinical drug development and associated processes
Must have extensive working knowledge of Microsoft Office Products including Outlook, Word, Excel and PowerPoint and Project
Excellent organizational, written and verbal communication skills

Education:

RN or BS/MS or equivalent in life sciences or BA with appropriate clinical research experience

Experience:

At least 7 years of experience in the management of clinical research programs in a CRO, biotech or pharmaceutical company; expertise in oncology trials a plus. Extensive knowledge and experience managing operational aspects of clinical trials is essential.
Experience in supporting IND, protocol, and IB development
Experience working with medical professionals in oncology a plus

Special Requirements:

Travel up to 20%

Salary:

Salary and title commensurate with experience and responsibility.

Available Jobs		Share Available Jobs at Mersana Senior Clinical Program Manager Please check back often for new openings. Our benefits include: Medical insurance Dental insurance Life/AD&D insurance Long-term disability insurance 401(k) plan 11 paid holidays 15 vacation days Please send your resume to careers@mersana.com or Mersana Therapeutics, Inc. Attn: Human Resources 840 Memorial Drive Cambridge, MA 02139 NO PHONE CALLS PLEASE. Mersana Therapeutics, Inc. is an equal opportunity employer. Senior Clinical Program Manager - (reference code: SCMP) November 24, 2009 Mersana Therapeutics employs its biodegradable polymer platform (Fleximer^®) to create new and better medicines. We are advancing our own clinical-stage pipeline of novel compounds with the potential to address multiple oncology indications. We also leverage the versatility of Fleximer through partnerships to overcome the safety, efficacy, and delivery challenges of nucleic acids, biologics, and small molecules in numerous therapeutic areas. We are seeking an experienced, enthusiastic project leader who thrives in a fast-paced work environment and who will become an integral member of our Clinical Development group. Reporting to the Chief Medical Officer, the Senior Clinical Program Manager's primary function is to lead the management of the operational aspects of clinical programs. The Senior Clinical Program Manager has the experience to execute a clinical plan for an oncology drug development candidate so that compounds are developed in a manner that is timely, within budget, and to a high medical and scientific standard. Specific Responsibilities: Maintains a daily, "hands-on" approach to the management of the external vendors, CROs, and clinical sites - supporting site budget negotiations and investigator contracting, site initiation, tracking patient enrollment, site monitoring, and site close-out. Manages the planning, tracking and adherence to allocated budget and timelines. Resolves issues affecting clinical program and operations; plans contingencies for potential concerns. Contributes to the development and review of protocols to achieve the aims of the development plan. Collaborates with relevant internal and external (CROs) groups on the initiation and execution of clinical studies. Works with the Chief Medical Officer and clinical development group, study sites, and CRO to ensure operational feasibility of protocols and programs for successful implementation. Assists in the preparation of responses to regulatory agencies regarding program development issues. Adheres to Code of Federal Regulations, ICH Guidelines and all other applicable ethical, regulatory, and clinical standards. Supports the production of draft regulatory documents and study reports. Ensures medical/scientific quality of the documents and accordance with regulatory guidelines and the overall development strategy. Contributes to preparation of abstracts, manuscripts, and external presentations. Remains current in the scientific/clinical knowledge for the compounds under clinical investigation in the company. Establishes and fosters an atmosphere conducive to teamwork within the company and with outside project participants. Other requirements: Working knowledge of GCPs, ICH Guidelines, and federal regulations Knowledge of clinical drug development and associated processes Must have extensive working knowledge of Microsoft Office Products including Outlook, Word, Excel and PowerPoint and Project Excellent organizational, written and verbal communication skills Education: RN or BS/MS or equivalent in life sciences or BA with appropriate clinical research experience Experience: At least 7 years of experience in the management of clinical research programs in a CRO, biotech or pharmaceutical company; expertise in oncology trials a plus. Extensive knowledge and experience managing operational aspects of clinical trials is essential. Experience in supporting IND, protocol, and IB development Experience working with medical professionals in oncology a plus Special Requirements: Travel up to 20% Salary: Salary and title commensurate with experience and responsibility.

Available Jobs at Mersana