Senior Director, Experimental Medicine (Immuno-oncology) at Alkermes in Waltham, MA
Additional responsibilities include:
Creating experimental medicine strategies consistent with corporate and program objectives and delivering results that inform go/no-go decision points for oncology programs. Study lead and internal PI on early-stage clinical development trials. Development project leader, functional area lead on project core teams and development or research sub-teams. Integrate experimental medicine strategy and tactics into broader clinical development plans and execute on those plans in close coordination with project teams and R&D leadership. Review and provide clinical and medical expert input on regulatory documents, including but not limited to development plans, study protocols and reports and documentation supportive of IND and NDA filings. Strategic oversight of selection and integration of contract research organizations and engagement with internal functions (e.g., operations, clinical development, outsourcing and legal teams) required for executing experimental medicine studies. Creating and presenting experimental medicine study concepts and formal proposals to program teams and executive R&D committees that inform, educate and gain alignment on strategic, tactical and logistic components of early clinical and translational plans. Active participation and leading discussions at the oncology scientific advisory boards for the company Expert review in support of business development objectives. Basic Requirements:
MD, MD/Ph.D. or equivalent advanced sciences degree(s) and experience including at least 10 years of clinical immuno-oncology R&D experience with several years in an industrial biopharmaceutical organization. Preferred Requirements:
Deep expertise in clinical immuno-oncology biomedical research and development and experience applying it in a fast-paced and risk-taking business environment. Knowledge of historical, current and emerging technologies, scientific advances and therapeutics discovery and development trends in immuno-oncology. Strong network of personal and professional experts in the immuno-oncology field. Creativity, commitment to scientific rigor, and passion for conceiving and implementing innovative study designs will also be important for leading and delivering on the vision and potential of oncology experimental medicine. Proactive, strategic and tactical thinker with an action-oriented style that leads to tangible work products created by you and via collaborative efforts with a diverse array of internal and external colleagues. Thorough understanding of clinical development and discovery research, clinical trial logistics and management of vendors and their roles in clinical trials. Familiarity with regulatory processes, strategy and guidance.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Creating experimental medicine strategies consistent with corporate and program objectives and delivering results that inform go/no-go decision points for oncology programs. Study lead and internal PI on early-stage clinical development trials. Development project leader, functional area lead on project core teams and development or research sub-teams. Integrate experimental medicine strategy and tactics into broader clinical development plans and execute on those plans in close coordination with project teams and R&D leadership. Review and provide clinical and medical expert input on regulatory documents, including but not limited to development plans, study protocols and reports and documentation supportive of IND and NDA filings. Strategic oversight of selection and integration of contract research organizations and engagement with internal functions (e.g., operations, clinical development, outsourcing and legal teams) required for executing experimental medicine studies. Creating and presenting experimental medicine study concepts and formal proposals to program teams and executive R&D committees that inform, educate and gain alignment on strategic, tactical and logistic components of early clinical and translational plans. Active participation and leading discussions at the oncology scientific advisory boards for the company Expert review in support of business development objectives. Basic Requirements:
MD, MD/Ph.D. or equivalent advanced sciences degree(s) and experience including at least 10 years of clinical immuno-oncology R&D experience with several years in an industrial biopharmaceutical organization. Preferred Requirements:
Deep expertise in clinical immuno-oncology biomedical research and development and experience applying it in a fast-paced and risk-taking business environment. Knowledge of historical, current and emerging technologies, scientific advances and therapeutics discovery and development trends in immuno-oncology. Strong network of personal and professional experts in the immuno-oncology field. Creativity, commitment to scientific rigor, and passion for conceiving and implementing innovative study designs will also be important for leading and delivering on the vision and potential of oncology experimental medicine. Proactive, strategic and tactical thinker with an action-oriented style that leads to tangible work products created by you and via collaborative efforts with a diverse array of internal and external colleagues. Thorough understanding of clinical development and discovery research, clinical trial logistics and management of vendors and their roles in clinical trials. Familiarity with regulatory processes, strategy and guidance.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
