10 days old

Associate Director, Clinical Pharmacology

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    220561
Overview

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines.
Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.
Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, "change the world" kind of people who are ready to say, "challenge accepted" to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company's 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount's 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg's Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

The Associate Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising RNAi therapeutics. Currently there are 5 products in phase 3 development and an active mid-stage clinical and preclinical pipeline that produces approximately 3 additional new clinical programs annually. The candidate in this key position will be responsible for clinical PKPD, clinical pharmacology strategic and tactical aspects on project teams. In this role, the candidate is expected to have a strong regulatory and scientific foundation pertaining to drug development and play an active role on the program team. The candidate is expected to conduct PK/PD analyses to guide decision making on the project teams.

Summary of Key Responsibilities

  • Supports clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
  • Conduct PK and PK/PD analysis to guide development decisions on project teams .
  • Work closely with pharmacometrics team members and provides input related to analysis and reporting of PK and PK/PD.
  • Authors clinical pharmacology sections for regulatory filings including annual reports, investigator's brochure, IND/NDA applications and pediatrics development
  • Design and oversee the conduct of clinical pharmacology studies (either standalone or within broader clinical trials) to generate high quality and relevant data.
  • Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues.
  • Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
  • Participates in the preparation of abstracts and manuscripts for publication
  • Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Project Management, and other R&D functions development plans.

Qualifications

  • Candidates with a Ph.D. (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field
  • 3-5 years of clinical pharmacology or pharmacometrics experience in pharmaceutical industry, consulting, or regulatory agency.
  • Strong working knowledge of pharmacokinetics, pharmacodynamics, modeling, PKPD principles, ADME concepts, drug development and clinical pharmacology.
  • Ability to independently interrogate results and provide actionable guidance to project teams
  • Proficient in using Phoenix WinNonlin, NONMEM, or other pharmacokinetic and modeling software.
  • Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.
  • If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required

Superior Skills/Abilities:

  • Passionate about science and driven by scientific curiosity
  • Open minded, receptive to input and a strong team player
  • Self-driven, able to multi-task and manage time-sensitive workloads
  • Problem solver with ability to transform complex tasks into actionable deliverables
  • Strong interpersonal skills with ability to work in matrix environment
  • Strong written and oral presentation skills

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.





Posted: 2022-08-02 Expires: 2022-08-31
Sponsored by:
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Associate Director, Clinical Pharmacology

Alnylam Pharmaceuticals
Cambridge, MA 02139

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