Associate Director, Clinical Development Scientist
About The Position
The Associate Director, Clinical Development Scientist may lead a cross-functional team in the design and execution of clinical studies and may contribute to global clinical development plans and therapeutic-area strategy. The role supports assigned clinical development physicians and the therapeutic area head with deliverables needed for effective clinical development plan design and execution. The position leads preparation of clinical study documents and may manage several studies in parallel. It leads study design and execution, including protocol development and review, site and country selection, training, recruitment, data monitoring, analysis, and closeout. The role works with investigators, site staff, CROs, internal and external partners, and cross-functional teams to support high-quality clinical execution and interpret clinical data. The Associate Director maintains awareness of scientific, clinical, competitive, and regulatory developments and synthesizes relevant information to inform development programs, asset plans, and therapeutic-area strategy. The position may supervise and develop clinical development scientists or fellows, lead a translational science subteam or program, and support business development activities such as due diligence and research collaborations. The role is based in Boston, Massachusetts, and follows a hybrid working approach, with employees engaging face-to-face in the office three days per week.
Requirements
- Bachelor's degree.
- Understanding of general and specific therapeutic principles.
- Knowledge of clinical research methodology, statistics, data analysis, and interpretation.
- Familiarity with scientific literature searches and evaluation of peer-reviewed data quality.
- Ability to communicate clearly, orally and in writing, with internal and external partners.
- For assigned clinical endpoint support such as imaging, experience in at least one meaningful modality, such as ultrasound, computerized tomography, magnetic resonance, or positron emission tomography.
- Specific therapeutic-area experience.
- Understanding of strategic versus tactical thinking.
- Experience interacting with varying levels of internal and external management, academicians, clinicians, or scientists.
- Strong business intuition and in-depth knowledge of multidisciplinary drug-development functions, such as clinical operations, biostatistics, regulatory, and commercial operations, with the ability to integrate multiple perspectives into clinical development.
- The posting states that 5+ years of industry experience in clinical development is preferred.
Nice To Haves
- Advanced scientific degree (M.S., Ph.D., Pharm.D., MPH, or similar) is listed as desirable; the posting also describes it as required in the desirable-skills section.
- Advanced knowledge of the assigned therapy area.
Responsibilities
- Lead teams preparing clinical study documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents; may manage several studies in parallel.
- Lead clinical study teams in protocol design, engage relevant internal and external partners, prepare materials and protocol defense presentations for C-PRC review, and represent the study team at the clinical sub team.
- May supervise and develop clinical development scientists and/or fellows.
- Participate in investigator meeting planning and execution and/or on-site initiation meetings.
- Lead clinical trial execution and monitor, clean, analyze, and review safety and efficacy data to identify trends and follow up as appropriate.
- Guide study execution, including country and site selection, site training and start-up, data monitoring, patient recruitment, and study closeout.
- Depending on expertise in translational science, may lead a translational sub team of the clinical team.
- Liaise with other functions to build external expert consultations and contribute to study concepts, designs, protocols, and essential documents.
- Engage clinical investigators to support quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team on clinical and therapeutic-area strategy.
- Engage investigators, site staff, CROs, and site monitors to support enrollment in ongoing clinical studies.
- Where appropriate, serve as subject-matter expert for identification, translation, inclusion, implementation, and reporting related to liquid, tissue, and/or imaging endpoints.
- Maintain awareness of scientific, clinical, competitive, and regulatory developments, including through conferences, competitive intelligence activities, and literature reviews.
- Critically evaluate disease-area and competitive-landscape information and synthesize it to support clinical development programs, asset plans, and therapeutic-area strategy.
- Help determine appropriate advisory-board experts.
- Support business development activities, including due diligence and research collaborations.
- May serve as the Translational Science lead for one or more programs.
Benefits
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
