Associate Director, Clinical Development Scientist

Job Title: Associate Director, Clinical Development Scientist

Location: Boston, MA

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Introduction to Role:

The Associate Director, Clinical Development Scientist (CDS) may lead a cross functional team in the design and execution of a clinical study and may provide input into the global clinical development plans and strategy for a therapeutic area. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical development plan design and execution and therapeutic area strategy.

Accountabilities:

• Lead a team in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents (may manage several studies in parallel).

• Lead a study team to design a clinical protocol, including engaging with relevant internal and external partners; responsible for preparing materials and protocol defense presentation for C-PRC review. Represent the clinical study team at the clinical sub team.

• May supervise and develop clinical development scientists and/or fellows; Lead a team in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents

• Participate in Investigator meeting planning and execution and/or on-site initiation meetings

• Lead the execution of clinical trials; Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.

• Lead a team in study execution, including country and site selection, site training and start-up and data monitoring; expertise in data analysis and presentation required. Depending upon specific expertise in translational science, may lead a translational sub team of the clinical team.

• Liaise with other functions to build external expert consultations, contribute to the development of study concepts and designs, protocols and study essential documents.
• Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy.
• Engage with investigators, site staff, CROs, and site monitors to maintain passion and support enrollment for ongoing clinical studies. Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting related to liquid, tissutal and/or imaging endpoints.

• Lead the execution of clinical trials and associated data collection activities, providing guidance to the clinical study team related to: country and site feasibility assessments and selection
• Site training and oversight

• Patient recruitment

• Ongoing data monitoring

• Study closeout

• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy

• Help to determine appropriate advisory boards experts

• Provide support for business development activities, such as due diligence and research collaborations

• May serve as the Translational Science lead for one or more programs

Essential Skills/Experience:

• Bachelor's Degree
• 5+ years of industry experience in clinical development is preferred
• Understanding of general (and specific) therapeutic principles

• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation

• Familiar with scientific literature searches and weighing of quality peer reviewed data

• Ability to clearly communicate to internal and external partners orally and in writing

• For those assigned to clinical endpoint support, e.g., imaging, experience in at least one meaningful modality, e.g., ultrasound, computerized tomography, magnetic resonance, positron emission tomography

• Specific therapeutic area experience

• Basics of strategic vs. tactical thinking

• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.

• Strong intuition for business; including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results

Desirable Skills/Experience:

• Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree) required

• Advanced knowledge of the assigned therapy area is desired

Where can I find out more?

• Follow AstraZeneca on LinkedIn
• Follow Alexion on LinkedIn
• Follow AstraZeneca on Facebook
• Follow AstraZeneca on Instagram
• Learn more about Alexion at www.alexion.com

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

Total Rewards:

The annual base pay (or hourly rate of compensation) for this position ranges from $142,171 to $213,256 . Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.