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Senior Director, Clinical Operations

Company: Alnylam Pharmaceuticals
Location: Cambridge
Posted on: September 25, 2022

Job Description:

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines.

Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.

Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, "change the world" kind of people who are ready to say, "challenge accepted" to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company's 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount's 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg's Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

The Sr. Director, Clinical Operations Study Management is an operational and drug development subject matter expert accountable for the delivery of trials within their assigned portfolio of clinical trials. He/she will partner with other Clinical Operations and Expertise Area leaders. He/she must be able to collaborate, influence and lead discussions with key leaders/stakeholders to determine program priorities and will define and implement resourcing and execution strategies. He/she will provide strategic and operations leadership across clinical projects and contribute to defining the overall program strategy. He/she may also provide strategic program direction and oversight of clinical research activities, including clinical development plans, study design, protocol development, study and operational feasibility and risk assessment, key CRO relationships, KOL relationships, throughout all phases of clinical development.

The Director/Sr. Director, Clinical Operations Study Management is an effective team leader. He/she is responsible for the talent development, provides line management and supervision of team members in his/her group. He/she is responsible for building clinical operations, therapeutic area and technical skills within his/her group to ensure patient safety, quality clinical trial execution and effective delivery of trials. He/she is also a member of the Clinical Operations Leadership team and as such supports and influences the direction of the Clinical Operations group.

The Director/Sr. Director, Clinical Operations Study Management is accountable for the delivery of clinical trials within his/her assigned portfolio and for ensuring appropriate management of study vendors/CROs. He/she will collaborate with internal stakeholders on the oversight of vendors/CROs. He/she will assist in resolving or escalating issues as needed. He/she is responsible to ensure the clinical trials in their group are adequately resourced, sets priorities, manages operational plans and budgets.

The Director/Sr. Director, Clinical Operations Study Management serves as an expert in clinical operations processes and is responsible for developing and sharing best practices within his/her team and across the Clinical Operations organization. He/she will work with other Clinical Operations and Expertise Area leaders to formulate strategies, standards, processes and best practices to be implemented for the benefit across Clinical Operations.

The Director/Sr. Director, Clinical Operations Study Management ensures strong interaction with local country, medical affairs teams/regional medical groups and other strategic partners as needed for the successful delivery of clinical trials.

Summary of Key Responsibilities

  • Partners directly with or guides internal staff along with the CRO team(s) to collaborate with preclinical (pharmacology, toxicology, drug safety and metabolism), regulatory affairs, medical monitoring, biometrics, medical affairs, pharmacovigilance, and/or medical writing to develop drug development strategies, protocol and study designs, and other key study and program deliverables. Has overall accountability for the development of the Clinical Operations study/project strategy for assigned projects.
  • Communicates program strategy, goals and priorities across a wide range of audiences ensuring that they are understood and supported.
  • Active participation as a member of the Clinical Operations Leadership Team in driving strategy and team execution.
  • Participates in protocol, IB, ICF, Regulatory submission documents, CRF, CSR, abstract and publication development and review and provides direction to junior staff to manage the content and process, as necessary.
  • Effectively discusses and presents study data across the company and with development partners; collaborates with medical writers and investigators to write, present and/or publish data.
  • Maintains appropriate therapeutic area technical and working knowledge of scientific and clinical operations developments.
  • Responsible for the guidance of clinical staff, including hiring, performance management and ongoing coaching. If UK based, participates as member of UK office leadership team under UK General Manager (GM) supporting the development and continue growth of the UK team whilst also ensuring alignment with UK HQ counterparts.
  • Develops and implements strategies to maximize study management competency and skills related to clinical operations trial delivery.
  • Responsible for shaping the Clinical Operations team culture including the retention and engagement of team members.
  • Leads teams towards departmental and project productivity and quality metrics and provides financial and management accountability.
  • Manages the recruitment and performance of junior staff to support and guide them to improved strategic drug development operational efficiency, effectiveness at prioritization, and problem identification and solving.
  • Acts as point of contact for leadership including resolution or escalation of issues as appropriate.
  • Participates in and provides direction on development of Clinical Operations Plans, Clinical Research Organization (CRO) outsourcing strategy, and key performance indicators (KPIs) with CRO and reviews KPIs during projects.
  • Oversees the development of tracking tools and guides staff on effective management of project teams, project budgets, study timelines, and deliverables.
  • Guides teams and identifies and reports potential program issues and resource deficiencies effectively and in a timely manner and implements corrective action.
  • Accountable to deliver excellence in clinical operations study management for a portfolio of clinical trials, ensuring the trials progress in accordance with agreed plans.
  • Collaborates with vendor/CRO partners, internal groups in the development of and compliance with robust inspection readiness plans to ensure high quality clinical trial conduct and data integrity.
  • Partners with Quality Assurance and Clinical Operations Oversight teams to ensure team, vendor/CRO partners consistently deliver data which supports regulatory requirements.
  • Actively participates and/or leads in the development of the Clinical Operation department's vision, standards and successful implementation of process improvements and change.
  • Instills a culture of continuous improvement; acts as a change champion and effectively leads change
  • Maintain awareness of biopharmaceutical business, operational trends and external organizational developments to help define future strategic direction.
    Qualifications
    • University Degree in Science or related discipline. A higher degree would be desirable.
    • Significant (10+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies and program strategy.
    • Considerable (5+ years) managing clinical studies and direct reports.
    • Must have experience leading/managing external CRO cross functional teams.
    • Experience in the clinical drug development process within clinical program planning, startup including budget & resource planning through final study report.
    • Proven track record in department visioning, resource planning forecasting, and budgeting.
    • Ability to travel up to 30%.
    • Sr. Director qualifications include the above plus:
    • Extensive (minimum 15+years) experience with a CRO or biopharmaceutical company and track record of success in global clinical operations or related disciplines.
    • Significant (10+ years) line management experience including experience in leading global clinical program teams comprising of several global clinical trials and indications.
    • Experience in leading global and/or remote based teams.
    • Expert knowledge of global regulatory and compliance requirements for clinical trials.

      Requirements

      • Must be self-motivated and able to work independently and successfully.
      • Must be able to successfully manage remote base team members as needed and as part of an international development team reporting into our USA based headquarters.
      • Able to prioritize effectively, lead and influence, with good problemsolving and planning abilities to enable teams succeed in study start, execution and completion in a timely fashion. Strong organizational skills and ability to deal with competing priorities.
      • Comprehensive regulatory knowledge, including Good Clinical Practices (GCPs).
      • Willingness to travel internationally as required. If UK based, quarterly trips to US headquarters. If US based supporting UK team members, bi-monthly-quarterly trips to UK offices.
      • Superb communication skills (written, verbal and presentation).
      • Ideally a combined mix of large company best practices and small company adaptability and experience.
      • Willingness and proven ability to work flexibly stepping outside of immediate role responsibilities and wear 'multiple-hats' where needed.
      • Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally.
      • Strategic Thinking: General knowledge of all major aspects of drug discovery and development along with effective departmental leadership to be an effective problem solver for complex problems.
      • Scientific Understanding: Thorough comprehension of therapeutic mechanisms of focus and current scientific developments within his/her area of expertise to provide recommendations on both project and disease area levels.
      • If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required

        Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

Keywords: Alnylam Pharmaceuticals, Cambridge , Senior Director, Clinical Operations, Executive , Cambridge, Massachusetts

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