Senior Director, Therapeutic Area Lead
2 weeks ago
Senior Director level role that identifies unmet medical needs and develops medical plan to support development and commercialization of products.
- Leverages medical and scientific insights to develop medical plan for product(s) in hematologic malignancies, hematology and oncology area.
- Generates data plan, medical publication plan, and medical education plan to support development and commercialization of organization’s products (the Medical Affairs Plan).
- Develops and manages medical publication plans with Publication team.
Planning and Execution
- Leverages medical and scientific insights to develop medical plan for product(s) in hematologic malignancies, oncology area.
- Ensures execution of medical affairs tactics in the hematologic malignancies, oncology area.
Financial Outcome
- Develops strategic data generation plan in hematologic malignancies, oncology area for Medical Affairs sponsored trials to address existing and future data gaps and support reimbursement needs.
- Supports HEOR team; designs and conducts health economic studies.
Operation and Improvement
- Develops and manages medical publication plans with Publication team.
- Partners with therapeutic leads to set a common medical objective and share medical activities and experience.
- Provides scientific and medical advice to develop study synopsis, protocols, and study reports.
Innovation
- Generates data plan, develops Investigator Initiated Trial (IIT) scope and guidance document, medical publication plan, and medical education plan to support development and commercialization of organization’s products.
Talent Development and Organization Growth
- Ensures medical science liaison (MSL) teams are fully trained on the resources; supports the US field medical teams through the development of scientific communication plan and tools to address healthcare provider needs
External/Internal Relationship
- Develops key opinion leadership (KOL) relationships.
- Develops and delivers scientific presentations to both internal and external stakeholders.
- Develops and executes US symposium and educational meetings within the area.
Educational Requirements
- Advanced degree (M.D. PhD or PharmD, Nurse Practitioner) in a scientific discipline.
Experience
- 5 to 10 years of pharmaceutical or related industry experience (HealthCare Agencies); majority of experience must be in medical affairs in the US.
- Experience with clinical trials; expertise in the therapeutic area of oncology is a plus.
- Experience in a matrix, cross-functional environment.
Technical Skills
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Cognitive Skills
- Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources to achieve desired outcomes.
Language/Interpersonal Skills
- Ability to effectively present to and connect with the members of a diverse audience.
-
Senior Director, Therapeutic Area Lead
2 weeks ago
Cambridge, United States ONO PHARMA USA Full timeSenior Director level role that identifies unmet medical needs and develops medical plan to support development and commercialization of products.Leverages medical and scientific insights to develop medical plan for product(s) in hematologic malignancies, hematology and oncology area.Generates data plan, medical publication plan, and medical education plan...
-
Cambridge, United States Biogen Idec Full timeCompany DescriptionJob Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and...
-
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout the role:The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the...
-
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout the role:The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the...
-
Cambridge, United States Biogen Full timeCompany DescriptionJob DescriptionAbout the role:The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking a Senior Director, Clinical Operations to manage therapeutics programs across the Therapeutics portfolio with a focus on Rare Diseases. The Senior Director, Clinical Operations, Therapeutics will function as a portfolio lead with oversight of programs and the clinical operations team(s) on those programs. This position will work...
-
Senior Director, In Vivo Therapeutics
4 weeks ago
Cambridge, United States Editas Medicine, Inc. Full timeAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Senior Director, In Vivo Therapeutics
4 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Senior Director, In Vivo Therapeutics
1 month ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Associate Director, Clinical Operations
6 days ago
Cambridge, United States Moderna Theraputics Full timeThe Role: Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related...
-
Cambridge, United States Biogen Idec Full timeCompany DescriptionJob Description About This Role: We are seeking a highly motivated Senior Medical Director to lead development strategy and oversee the clinical development team for one or more assets in the areas of neuropsychiatry and pain in programs that span from first in human studies through filings and approval as well as post-marketing...
-
Associate Director, Clinical Operations
6 days ago
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related...
-
Cambridge, United States BioSpace Full timeJob DetailsThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and...
-
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related...
-
Senior Director, CMC Lead
5 days ago
Cambridge, United States Repertoire Immune Medicines Full timeJob DescriptionJob Description Senior Director, CMC LeadCompany OverviewRepertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease and infectious...
-
Senior Director, CMC Lead
5 days ago
Cambridge, United States Repertoire Immune Medicines Full timeJob DescriptionJob Description Senior Director, CMC LeadCompany OverviewRepertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease and infectious...
-
Cambridge, United States Pfizer Full timeROLE SUMMARY Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma and haemato-oncological malignancies. Pfizer's in-line portfolio is focused on four broad, key areas: breast cancer, genitourinary cancer, hematology...
-
Cambridge, United States Biogen Full timeCompany DescriptionJob DescriptionAbout This Role:We are seeking a highly motivated Senior Medical Director to lead development strategy and oversee the clinical development team for one or more assets in the areas of neuropsychiatry and pain in programs that span from first in human studies through filings and approval as well as post-marketing commitments...
-
Director - Business Development
6 days ago
Cambridge, Massachusetts, United States Novo Nordisk Full timeAbout the Department The Novo Nordisk Cambridge location is the headquarters for Global Business Development across all of our therapeutic and technology areas.We contribute to innovation in one of the world's largest life sciences ecosystems by participating in events and discussions with renowned and upcoming scientists-looking for the next scientific...
