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Medical Director
1 day ago
Precision Life Sciences Cambridge, United StatesProvide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. This position will fill an open vacancy while an FTE is hired. · - Lead the development of clinical trial protocols, ensuring scientific r ...
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medical director/executive medical director
1 week ago
Dragonfly Therapeutics Waltham, MA, United StatesMedical Director/Executive Medical Director · Dragonfly Therapeutics seeks a knowledgeable, experienced and motivated individual to join our team and support clinical stage activities. Reporting to the SVP of Clinical Development, this role will be responsible for developing and ...
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Medical Director
1 week ago
Apex Ventures Logan, United StatesThere are many reasons to collaborate with European Medical Consulting Adam. In the following section, you will see how you can benefit from our free services and save valuable time: * You will have access to exclusive and unpublished job opportunities * Our relocation service wi ...
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Medical Director/Executive Medical Director
3 days ago
Dragonfly Therapeutics, Inc. Waltham, United StatesMedical Director/Executive Medical Director · Dragonfly Therapeutics seeks a knowledgeable, experienced and motivated individual to join our team and support clinical stage activities. Reporting to the SVP of Clinical Development, this role will be responsible for developing and ...
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Medical Director
1 week ago
Infinity Systems Milton, United StatesThe German Pension Insurance Westphalia is seeking a new Medical Director and Chief Physician (m/f/d) for their Münsterland Clinic in Bad Rothenfelde (successor to Prof. Dr. Bernhard Greitemann). The ideal candidate will also serve as the Head of the Department of Orthopedics and ...
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Medical Director
1 week ago
Mass General Brigham Community Physicians Waltham, MA, United States Full timeNewton-Wellesley Medical Group (NWMG), a member of Mass General Brigham Community Physicians, is seeking a Medical Director to oversee our outpatient primary care practice located in Waltham, MA. Candidates must be board certified or board eligible in FM or Med-Peds. · The Role: ...
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Medical Director
2 days ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Medical Director of Ophthalmology will be a key contributor to the Ophthalmology Program at Apellis. This position will have oversight of the clinical studies in Geographic Atrophy, and potentially participate in clinical d ...
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Medical Director, Neurology
6 days ago
Freeline Therapeutics Boston, United States**Benefits**: · - Generous holiday allowance- Life assurance- Gym membership- Medical cover- Pension- Shower at work- Sport clubs- GP consults- Why Freeline? · - Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work ref ...
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Medical Director
2 weeks ago
Apellis Waltham, MA, United StatesJob Description · Job Description · Position Summary: · The Medical Directorof Ophthalmology will be a key contributor to the Ophthalmology Program at Apellis. This position will have oversight of the clinical studies in Geographic Atrophy, and potentially participate in clini ...
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Medical Director
1 week ago
Crimson Enterprises Hopedale, United StatesThere are many reasons to collaborate with European Medical Consulting Adam in Hopedale. In the following section, you will see how you can benefit from our free services and save valuable time: * You will have access to exclusive and unpublished job opportunities * Our relocatio ...
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Executive Director, Medical Director
1 week ago
BioSpace Waltham, United StatesJob Details · Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern olig ...
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Executive Director, Medical Director
2 weeks ago
Dyne Therapeutics Waltham, MA, United StatesWith its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) ...
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Executive Director, Medical Director
3 days ago
Dyne Therapeutics, Inc. Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide thera ...
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Executive Director, Medical Director
3 days ago
Dyne Tx Waltham, United StatesOur commitment to people with muscle diseases · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing m ...
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Medical Director, Clinical Development
2 days ago
Alexion Pharmaceuticals,Inc. Boston, United StatesLocation: Boston, United States · Job reference: R-197377 · Date posted: 04/16/2024 · **Position Summary** · - The medical director contributes to a cross-functional team in the design and execution of one or more clinical studies and provides input to the clinical development pl ...
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Executive Director, Medical Director
2 weeks ago
Dyne Tx Waltham, MA, United StatesOur commitment to people with muscle diseases · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing ...
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Executive Director, Medical Director
3 weeks ago
Dyne Therapeutics Waltham, United States Full timeCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...
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Executive Director, Medical Director
2 weeks ago
Dyne Therapeutics Waltham, MA, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therap ...
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Medical Director, Pharmacovigilance
1 week ago
Deciphera Waltham, United StatesCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...
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director, medical affairs
1 week ago
Apellis Pharmaceuticals, Inc. Waltham, MA, United StatesPosition Summary: · The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the global medical affairs strategy for o ...
Senior Medical Director - Waltham, MA, United States - AstraZeneca GmbH
Description
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases.
We are more than one of the world's leading pharmaceutical companies.AstraZeneca has a multifaceted environment that cultivates collaboration and innovation. Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need.
With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death.
This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programsThe Senior Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.
The Senior Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product.
Accountabilities include clinical support for the development and implementation of early and/or late phase AstraZeneca sponsored clinical program strategies, including providing scientific input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e.
clinical input to (s)NDA/(s)BLA).The Senior Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients.
They share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study.The Senior Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-indication working groups depending on the level of experience.
The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.
Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management of other physicians or scientists.
Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safetyWork cross-functionally and lead all aspects of the design and implementation of clinical hemato-oncology projects, as leader of our Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST).
Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.Provide expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.
Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
Provides expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study reportFull responsibility for the planning, implementation and daily operation of assigned drug development projects in hemato-oncology.
Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Contribute to development and delivery of face to face or virtual investigator and monitor training.Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted
Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II or Phase III studies, innovating the process from protocol development thorough individual study report and coordinated regulatory documentation.
Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., Implement clinical R&D policies, SOPs and related directives.Review potential in-licensing candidates and present recommendations to Senior Management groups.
Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
Serve as mentor of less experienced staff that may include physicians or scientistsMD or international equivalent is required
Medical hemato-oncology clinical training is required
Significant clinical research experience (in industry, academic or CRO environment) related to drug development, design and/or conduct of clinical studies in oncology and/or malignant hematology is required.
Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.Possesses general knowledge of 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
Drug Development/Clinical Development Planning:
Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.
Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externallyWith science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world's most complex diseases.
Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.Find out more and follow AstraZeneca on:
