Director, Clinical Research- Benign Hematology

Alnylam Pharmaceuticals

5d•$255,000 - $345,000

About The Position

Alnylam Pharmaceuticals seeks an imaginative physician drug developer to provide clinical leadership in developing RNAi therapeutics across its neurology and hematology portfolio, spanning rare genetic and common diseases. The primary assignment is to serve as one of the clinical study leads for the plasminogen program as it transitions from Phase 2 to Phase 3. The Director reports to the program clinical development strategy lead, who oversees clinical research for the program, and helps shape overall clinical development strategy while advancing trial progress and operational excellence. The role involves extensive consultation and collaboration with external experts. Working in a matrix organization, the Director collaborates with Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial, and Quality Assurance teams to align development strategies. The Director also represents Alnylam Development at external meetings, including regulatory interactions and scientific meetings. The role requires an accomplished physician-scientist with strong scientific and clinical judgment, relevant research or industry experience, and the ability to lead and collaborate in an entrepreneurial biotech environment. The position is full-time and includes eligibility for annual short-term and long-term incentive awards.

Requirements

MD with a strong research background, or MD/PhD with excellent clinical and/or research training demonstrated through research support and peer-reviewed publications.
At least 3 years of industry experience or equivalent clinical academic research experience.
Sound scientific and clinical judgment.
Familiarity with clinical research and clinical trial concepts, including biostatistics, and with regulatory agency organization, guidelines, and practices.
Ability to present ideas effectively and document complex medical and clinical concepts in writing and orally.
Demonstrated critical thinking and problem-solving, superior judgment, and a balanced, realistic understanding of issues.
Outstanding leadership and collaboration skills in a matrix environment.
Ability to thrive in a highly entrepreneurial biotech environment and embrace Alnylam’s culture of science, passion, and urgency.

Nice To Haves

Board certification or equivalent, or specialist training in neurology.

Responsibilities

Serve as a subject matter expert for relevant disease areas.
Provide strategic leadership and a clear voice for the clinical program.
Develop creative but realistic drug-development approaches and lead clinical efforts toward global regulatory approvals.
Oversee trial conduct and safety.
Collaborate with Preclinical, Regulatory Affairs, and Medical Affairs to integrate product development plans.
Be accountable through Clinical Research and Operations for relevant timelines and deliverables.
Closely supervise major written deliverables, including regulatory submissions, original articles, and abstracts, as well as presentation materials.
Review and sign off on controlled documents, including protocols, investigator brochures, and informed consent forms.
Influence internal and external audiences in a high-impact, highly visible manner.
Collaborate across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial, and Quality Assurance teams.
Represent Alnylam Development at external meetings, including regulatory interactions and scientific meetings.