New · posted Nov 6
Alnylam Pharmaceuticals · Biotechnology
Director, Clinical Research
- Cambridge, MA
- Hybrid
- Full-time
- Director
The role
Alnylam Pharmaceuticals is seeking an imaginative physician drug developer, with the flexibility and confidence to work across diseases within the neurology and hematology therapeutic area. This role includes the opportunity to provide clinical leadership in developing RNAi therapeutics in Alnylam’s expanding portfolio, which spans from rare genetic to common diseases.
The successful candidate’s primary role will be one of the clinical study leads working on the plasminogen program transitioning from Phase 2 to Phase 3. The Director will report directly into the program clinical development strategy lead who provides the clinical research oversight of the program. The Director is expected to play a leading and influencing role in the overall clinical development strategies and drive progress and operational excellence of his/her clinical trial(s). This work will also involve extensive consultation and collaboration with external experts. The Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & Quality Assurance teams to ensure fully harmonized and integrated development strategies. The Director will be a key Alnylam Development spokesperson at external meetings, including regulatory interactions and scientific meetings.
What you need
A highly driven, dynamic, engaged and accomplished physician-scientist with experience and insight will thrive in this role. Specific qualifications include:
- MD with strong research background or MD PhD with best of class clinical and/or research training as shown through research support and peer-reviewed publications.
- Board Certification (or equivalent) or specialist training in neurology is desirable
- 3+ years industry experience or equivalent clinical academic research experience
- Sound scientific and clinical judgment
- Familiarity with concepts of clinical research and clinical trials, 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 critical thinking and problem solving while exhibiting superior judgment and a balanced, realistic understanding of issues
- Outstanding leadership and collaboration skills working within a matrix environment
- 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.
Skills named in this posting
- MD or MD PhD with research background
- Neurology board certification or training (desirable)
- 3+ years industry or clinical academic research experience
- Clinical trial oversight and safety
- Clinical development strategy
- Biostatistics familiarity
- Regulatory submissions and agency interactions
- Matrix leadership and collaboration
What you'll do
- Be a subject matter expert for the relevant disease area(s)
- Be the strategic leader providing a strong, clear voice for the clinical program
- Develop creative but realistic approaches to drug development and lead clinical efforts towards global regulatory approvals
- Oversight of trial conduct and safety
- Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
- Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.
- Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
- Be responsible for final review and sign off with respect to all controlled documents including protocols, investigator brochures, and informed consent forms.
- Influence internal and external audiences in a high impact, highly visible fashion
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAEqual opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
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.
Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
Director roles in Massachusetts62 roles publishing pay
Director roles in the US219 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Massachusetts (middle half) | $255,000 | $300,000 | $322,625 |
| All US (middle half) | $259,750 | $299,500 | $333,000 |
Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 282 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Clinical trial conduct4
- Documentation and SOPs3
- Regulatory submissions2
- Investigations and CAPA1
- Validation and qualification1
- MD or MD PhD with research background
- Neurology board certification or training (desirable)
- 3+ years industry or clinical academic research experience
- Clinical trial oversight and safety
- Clinical development strategy
- Biostatistics familiarity
- Regulatory submissions and agency interactions
- Matrix leadership and collaboration
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Alnylam on Regulatory Jobs
- 15
- Open roles
- 15
- Distinct roles
- 4
- Locations
By discipline
- Clinical8 53%
- Regulatory4 27%
- Quality3 20%
By level
- Director8 53%
- Manager3 20%
- Senior & Principal2 13%
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Director, Clinical Research at Alnylam
Open until filled.