Sr. Director, Clinical Research

This role is considered Hybrid.

Alnylam Pharmaceuticals is seeking an imaginative physician drug developer in Clinical Research - Metabolism and Obesity therapeutic area, also with the flexibility and confidence to work in therapeutic areas that may be beyond their expertise or experience. This is an opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam's rapidly expanding Metabolism and Obesity portfolio, which spans a number of diseases including type 2 diabetes mellitus and obesity.

The successful candidate's primary role will be as clinical lead for multiple programs in metabolism and obesity. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the programs and to drive progress and operational excellence for the associated clinical trials.

In addition, this role will include significant interaction with Alnylam's research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts.

The Sr. Director Clinical Research will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies. He/she will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.

Key Responsibilities

* Be the strategic leader providing a strong, clear voice for clinical programs.

* Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.

* Oversight of trial conduct and safety.

* Chair of CDST (Clinical Development Sub-Team), with accountability for the Clinical Development Plan.

* Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.

* Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.

* Be accountable via Clinical Research and Clinical Operations for all relevant timelines and deliverables.

* Contribute to and/or closely supervise (as relevant) all major written deliverables (protocols, IBs, informed consent forms, regulatory submissions, original articles, abstracts) and presentation materials.

* Managerial responsibility with 1-3 direct reports of Medical Director and/or Clinical Scientist.

* Influence internal and external audiences in a high impact, highly visible fashion.

Qualifications

A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:

* MD or MD PhD with Board Certification (or equivalent) or specialist training in Endocrinology

* 8+ years industry experience with major Phase 2 (multiple indications) or Phase 3 clinical program leadership experience in prevalent metabolism and/or obesity indications, including leading trial design and execution and successful regulatory interactions

* Ability to develop state-of-the-art CDPs and to navigate through internal governance boards in securing strategic approval of CDPs as well as resource planning and assignment

* Experience in effectively leading x-EA global clinical team (or CDST equivalent), managing direct reports with strong mentorship, and exhibiting effective collaborations with other EAs to fulfill program goals and objectives

* Strong medical monitoring skills

* Sound scientific and clinical judgment

* Familiarity with concepts of clinical research and clinical trial design, including biostatistics and regulatory agency organization, guidelines, and practices

* Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

* History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

* Outstanding leadership and collaboration skills working within a matrix environment

* Experience and knowledge of working with biotech/pharma partner(s)

* Thrives in highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion and urgency

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.