Director, Study Start-up and Site Partnership

2 weeks ago

Boston, United States Alexion Pharmaceuticals,Inc. Full time

Location: Boston, United States

Job reference: R-197638

Date posted: 04/18/2024

**This is what you will do**:
This Director, Study Start-Up and Site Partnerships is accountable for direction and oversight of the site activation process including contract and budget negotiations, and accountable for development and implementation of our operational institution relationship management strategy (including Partner In Care Network - PICN) for Country Operations Management (COM), at Alexion

The Director, Study Start-Up and Site Partnerships will work collaboratively with business stakeholders to position Alexion as the Sponsor of Choice for clinical sites.

This key role will require operational and strategic leadership skills, and role’s priority is to increase efficiencies in site start-up process and establish effective collaboration and partnership with institution stakeholders (clinical site staff, legal, contract and finance departments, regulatory coordinator for IRB pathway optimization).

Additionally, the Director, Study Start-Up and Site Partnerships will collaborate with other functions and leaders within COM (Head of COM and TA-aligned Directors, COM) and Alexion stakeholders (ClinOps, ClinDev) to develop and manage a best-in-class study start-up, institution relationship model, to maximize institution patient delivery across our Alexion portfolio.

**You will be responsible to**:

- Lead centralized team of Study Start-up Managers (SSUM), Site Contracts AD (SCAD), Site Alliance Leads (SAL), and Site Solutions Lead (SSL)
- Oversee start-up planning and execution activities, and site contracts and budget negotiations for efficient and expeditious site activations
- Create operational alignment that results in shorten study start-up timelines
- Lead development and implementation of site solutions (digital/non-digital) to address site gaps, establish preferred vendors for site solutions, and oversee deployment across key institutions
- Develop institution alliance strategy (including PICN)
- Direct and manage SAL to implement and maintain institution alliance strategy and activities with selected institutions, research networks, and site management organizations, for prioritized Therapy Areas.
- Establish strategic partnership models and frameworks to be deployed by SAL across key clinical institutions including Master and single contracts/ agreements, and governance models.
- Establish and measure KPIs to oversee study start-up milestones and institutional partnerships and performance
- Propose innovative solutions and contingency plans to site activation challenges/risks
- Consult within COM, Clinical Operations, Clinical Development leadership on new operational model, vendors, and strategies that may positively impact study-start-up, site alliance partnerships, site solutions.
- Collaborate with MAP and/or MSL leadership to ensure mutual site exchanges to create a “One Alexion” mentality
- Serve as a main point of contact internally for study start-up activities, and PICN
- Participate in the selection and oversight of clinical site vendors related to site solutions
- Drive the hiring of new people and onboarding of team, setting goals and expectations for operational delivery and metrics, aligned to business needs at the portfolio level.
- Work in collaboration with US COM Leadership team to support delivery of COM vision, mission and priorities
- Develop People and new talents within the team

**Qualifications**
- Bachelor degree in related discipline, preferably in life science, or equivalent combination of education, training and experience
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Minimum 10 years experience in Clinical Operations setting directly engaged in clinical trials
- Solid understanding of all aspects of clinical drug development process
- Proven experience in trial set-up, contracts and budget negotiations, site operational relationship management
- Proven experience in leading teams with direct people management experience
- Ability to set and manage priorities, budget, resources and performance targets
- Demonstrated experience in developing leading implementation of innovative strategies
- Strong interpersonal, and exceptional organizational skills
- Proven experience and effective communication skills (written, verbal, and presentation) and demonstrated networking and relationship building skills with internal and external stakeholders including senior leaders internally, and institutional staff and vendors, CRO partners, and Site Mangement Organizations.
- Ability to adapt to changing technologies and processes
- Well developed problem solving, organizational, and negotiating skills
- Excellent interpersonal skills across countries, cultures and organizational functions
- Demonstrates flexibility in schedule and willingness to travel

**Preferred Qualifications**
- Experience in running clinical studies for ultra-rare disea

  • Site Director

    1 week ago

    Boston, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionSite DirectorThe Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP...

  • Site Director

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States DM Clinical Research Full time

    Site Director The Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP guidelines and to provide...

  • Senior Project Director

    Found in: Jooble US O C2 - 1 week ago

    Boston, MA, United States Hebrew Senior Life Full time

    Overview The Marcus Institute for Aging Research seeks a Senior Project Director to work in the Brain Stimulation and Home-Based Neuromodulation Program run by Dr. Alvaro Pascual-Leone and Dr. Bradley Manor. The mission of the program is to provide effective brain stimulation treatments to individuals with dementia within their home, to train clinicians in...

  • Study Coordinator

    3 days ago

    Boston, United States Fenway Health Full time

    Job DescriptionJob DescriptionDescription:Under the direction of The Fenway Institute’s Associate Medical Director and the Clinical Research Operations Manager, the Study Coordinator will work with staff in the BioMedical Research Program at The Fenway Institute to support and implement clinical trials funded by a government agencies and/or industry...

  • Study Coordinator

    3 days ago

    Boston, United States Fenway Health Full time

    Job DescriptionJob DescriptionDescription:Under the direction of The Fenway Institute’s Associate Medical Director and the Clinical Research Operations Manager, the Study Coordinator will work with staff in the BioMedical Research Program at The Fenway Institute to support and implement clinical trials funded by a government agencies and/or industry...

  • PROGRAM DIRECTOR BWH CARDIOVASCULAR

    Found in: Careerbuilder One Red US C2 - 23 hours ago

    Boston, MA 02298, USA, United States Brigham and Women's Hospital Full time

    The Cardiac Imaging Core Lab (CICL) is an academic research organization located within the Brigham and Women's Hospital, a Harvard-affiliated hospital. The CICL provides echocardiography core laboratory services for primarily large-scale global clinical trials responsible for site training and interface as well as echo analysis of images received. The CICL...

  • Study Monitor USA

    14 hours ago

    Boston, United States Clinglobal Group Full time

    Job DescriptionJob DescriptionSalary: Between $68,000 and $90,000 per annumStudy Monitor - United States of AmericaClinglobal is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry. We're actively seeking a North American based Study Monitor to join our expanding Field Clinical Trials team...

  • Provider Partnerships

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Commonwealth Care Alliance Inc. Full time

    Provider Partnerships & Performance Intern #24-231 Internships Why This Role is Important to Us Commonwealth Care Alliance (CCA) is thrilled once again to host its Summer Internship Program for clinical and non-clinical departments! The Internship Program is open to undergraduate and graduate students from across the country. CCA Internships are a...

  • Lead Study Monitor USA

    2 days ago

    Boston, United States Clinglobal Group Full time

    Job DescriptionJob DescriptionSalary: Between $96,000 and $150,000 per annumLead Study Monitor - United States of AmericaClinglobal is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry. We're actively seeking a North American based senior Study Monitor to join our expanding Field Clinical Trials...

  • Sr Clinical Study Manager

    6 days ago

    Boston, United States CareerBuilder Full time

    ProKidney is a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for Chronic Kidney Disease, with the potential to preserve kidney function and change patients' lives. We are currently growing and looking to add an experienced Sr. Clinical Project Manager who...

  • Director-Strategic Alliances

    Found in: Jooble US O C2 - 3 days ago

    Boston, MA, United States MergerWare Corporation Full time

    Director-Strategic Alliances & Partnerships Description Position Mandate: Strategize the development and management of key relationships and alliances, including outreach, communications and strategy development that forms the core of the MergerWare business Work with executive management and across departments in further developing MergerWare Value...

  • Site/Civil Engineer

    1 week ago

    Boston, United States Hazen and Sawyer Full time

    Job DescriptionJob DescriptionHazen and Sawyer is seeking a Site/Civil Engineer to join our innovative team. Candidate should have 7 – 10 years of experience in the design and regulatory permitting of site plans, drainage studies, stormwater collection systems, Best Management and LID practices, and erosion control for construction. Specific experience in...

  • Partnership Accounts Manager

    6 days ago

    Boston, United States Lincoln Tech Full time

    Join the team at Lincoln Technical Institute's Corporate Office and become our next Partnership Accounts Manager! This role is primarily remote with significant travel. Take the helm in managing key industry relationships that will propel Lincoln Educational Services forward. As a trusted representative of our company, you'll oversee the administration and...

  • Partnership Accounts Manager

    5 days ago

    Boston, United States Lincoln Tech Full time

    Join the team at Lincoln Technical Institute's Corporate Officeand become our next Partnership Accounts Manager! This role is primarily remote with significant travel. Take the helm in managing key industry relationships that will propel Lincoln Educational Services forward. As a trusted representative of our company, you'll oversee the administration and...

  • Sales Director, Brand Partnerships

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Pointr Full time

    Pointr is a global leader in indoor location technology. Our mission is to deliver reliable, scalable, and intuitive location experiences to connect people with and within buildings across omnichannel Web, Mobile, and Kiosk platforms. Our Deep Location platform has revolutionized the indoor positioning, smart building, and IoT markets. We’re looking for an...

  • Director/Sr. Director, Clinical Science

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Scorpion Therapeutics Full time

    Job Summary Our Clinical Development team has an exciting new opportunity for someone to join as a Director/Senior Director, Clinical Science (Early Development). This person will provide scientific and clinical expertise to develop, design, conduct, analyze, and report global clinical trials in accordance with approved clinical development plans and...

  • Research Study Coordinator, Infectious Diseases

    2 days ago

    Boston, United States Boston Medical Center Full time

    **Position**:Research Study Coordinator, Infectious Diseases **Location**:Boston, MA **Schedule**:40 hours per week, Hybrid (On-site 2-3 days per week) **ABOUT BMC**: At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to...

  • Laboratory-Director-Travel

    Found in: Jooble US O C2 - 3 days ago

    Boston, MA, United States Third Rock Ventures Full time

    Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical...

  • Receptionist

    Found in: beBee jobs US - 1 week ago

    Boston, Massachusetts, United States Hire Partnership, LLC Full time

    Welcome to the Latest Job Vacancies Site 2024 and at this time we would like to inform you of the Latest Job Vacancies from the Hire Partnership, LLC with the position of Receptionist - Hire Partnership, LLC which was opened this. If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is...

  • Receptionist

    Found in: beBee S US - 1 week ago

    Boston, United States Hire Partnership, LLC Full time

    Welcome to the Latest Job Vacancies Site 2024 and at this time we would like to inform you of the Latest Job Vacancies from the Hire Partnership, LLC with the position of Receptionist - Hire Partnership, LLC which was opened this. If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is...