New · posted Nov 4
Alnylam Pharmaceuticals · Biotechnology
Director, Clinical Science
- Cambridge, MA
- Hybrid
- Full-time
- Director
The role
The Director, Clinical Science will be a member of the global clinical development team, working closely with other members of the clinical research group within clinical development (medical lead, medical monitor, statistician, medical safety director, safety manager and clinical pharmacologist) to support investigations that deliver the development strategies for therapeutic compound(s) under development. The Director, Clinical Science, contributes to the trial development strategy assisting with study design, protocol concept sheet, protocol development and clinical study execution inclusive of contribution of key regulatory documents. In addition, the Director, Clinical Science will contribute to clinical filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies.
What you need
- Minimum of a college degree in life sciences or nursing degree, advanced degree preferred (i.e. PhD, PharmD or MS) with 10+ years of experience in the pharmaceutical/biotech industry
- Experience in cardiovascular and large outcome trials is preferred.
- Proven track record of successfully executing multiple proof of concept and pivotal trials; (s)NDA submission and HA interactions experience is a plus
- The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize.
- Proven experience in developing effective relationships with key investigators.
- Experience in leading the team in a matrix setting.
What you'll do
- Clinical science expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
- Independently leads clinical execution of one or more studies; may be accountable for program level clinical deliverables
- May provide input to the protocol design document; leads development of the protocol, including protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
- Represents the clinical science team in internal protocol review committees, partners with/supports the Clinical Research Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions
- Ensures development of Study Informed Consent Documents and responses to external stakeholder (e.g., Health Authority and Independent Ethics Committee) requests
- Provides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
- Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan, ensuring alignment with the protocol and SAP, optimized data collection principles, and clinical data review best practice.
- Sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock
- Collaborates with Medical Safety and Pharmacovigilance on the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives
- Provides clinical guidance to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations
- Collaborates with the medical monitor on establishing and managing External Data Monitoring Committees and Adjudication Committees, including chartering, data provision and presentation of data, and documentation and dissemination of Committee recommendations, as appropriate
- Develops site selection criteria, provides clinical input to selection of sites, and ensures protocol training is delivered to site-facing colleagues
- Participates in investigator meeting planning and develops and delivers protocol training; develops and delivers ongoing protocol training in response to e.g., protocol amendments, emerging data issues, and quality events
- Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development, delivery, documentation, and curation (e.g., in FAQ)
- Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends review
- Ensures TMF compliance for clinical documents
- Provides clinical input and review of the Clinical Study Report
- Ensures disclosure of safety and efficacy data and trial conclusions; may contribute to primary publications
- Provides clinical support to audits and inspections, including responding to and addressing audit and inspection findings
- May contribute to clinical sections of regulatory filings (e.g., Briefing Documents, Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, Periodic Safety Update Reports, responses to Health Authority requests)
- Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution
- May have managerial responsibility for other clinical colleagues or contingent workers; may supervise, mentor, or develop others
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
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 4, 2026
Salary intelligence
How the pay compares
Director roles in Massachusetts64 roles publishing pay
Director roles in the US215 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Massachusetts (middle half) | $255,000 | $300,000 | $320,875 |
| All US (middle half) | $260,000 | $300,000 | $334,250 |
Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 277 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 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership16
- Clinical trial conduct15
- Documentation and SOPs13
- Investigations and CAPA7
- Regulatory submissions4
- GMP and compliance2
- Quality systems and risk2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- 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 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 E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- 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
- 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
Company hiring pulse
Alnylam on Regulatory Jobs
- 14
- Open roles
- 14
- Distinct roles
- 4
- Locations
By discipline
- Clinical7 50%
- Regulatory4 29%
- Quality3 21%
By level
- Director7 50%
- Manager3 21%
- Senior & Principal2 14%
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Director, Clinical Science at Alnylam
Open until filled.