- Program ownership with final accountability for precise definitions of program goals, plans, decisions and deliverables to meet those goals
- Responsible for developing the overall asset strategy, including indication sequencing and the overall regulatory and CMC strategy to support all the indications under development.
- Provide strategic direction and leadership to the GPTs to ensure precise goal setting and robust development plans for effective and efficient development of the asset overall.
- Ensures that the GPT, functional subteams and GPT members implement plans and adhere to key development milestones for assigned projects.
- Contributes to objective setting and appraisal of core team members for program-related activities
- Keeps senior management informed
- Ensures high-performance team effectiveness
- Total leadership experience including line/project management, multidisciplinary program management experience, which includes leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings.
- Minimum of ten (10) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
- Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency.
- Demonstrated experience leading drug development projects and activities in a matrixed, global organization.
- A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.
- A thorough understanding of how to influence local and global regulatory, scientific and commercial environments.
- Ability to assimilate data, recognize key variables and analyze complex situations to substantiate strategic recommendations.
- Has a realistic expectation of the business, oneself and others.
- A style which builds alliance within the organization, locally/globally, and/or corporate collaborators.
- Does not confuse effort for results.
- Tenacity to weather short-term setbacks for long-term advantages.
- Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.
- Solid understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings - IND/IMPD, BLA/NDA/MAA
- Has experience leading preparation of PMDA/EMA/FDA milestone meetings, such as Pre-IND, EoP-1, EoP-2, Pre-BLA/NDA, Advisory Committees, focusing on the key strategic issues.
- Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) - what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.
- Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.
- Advanced life-science degree (MD, PhD or PharmD) is preferable, with a speciality in Advanced Therapies or equivalent experience with global development required.
- Hands-on experience in developing Gene or cell therapy assets in clinical stage.
-
Intern - Cell Therapy
2 weeks ago
SARTORIUS AG Boston, United StatesAs the Biotechnology Research Intern, you will participate on characterization of bioreactors, and novel sensing platforms for cell therapy applications. In collaboration with the research team, the candidate will run systematic experiments using bioreactors, and perform data acq ...
-
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: · The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and man ...
-
Hydrogen Group Boston, United StatesSummary: · A leading Biotech company are seeking a motivated candidate to fill their Senior Scientific Process Development Specialist opportunity. This is an initial 12-month contract, with opportunity to extend. This is an onsite role based out of Boston, MA, with rotating weeke ...
-
Sales Executive
3 weeks ago
Inventia Life Science Boston, United StatesSales Executive - Life Science · Location: Boston (full-time & fully remote) · Do you want to help radically change the way the world treats disease and injury? Does the idea of solving complex problems with pioneering scientists conducting cutting-edge research ignite your passi ...
-
Director Global Market Access
4 weeks ago
Vertex Pharmaceuticals Boston, United StatesAbout the job · Job Description · Vertex operates at the forefront of scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF) as well as Casgevy, a new gene therapy for sickle cell disease and beta-thalassem ...
-
Director - Bioinformatics
3 weeks ago
Stealth Mode Boston, United StatesCompany Overview: · This stealth mode company is pioneering novel small-molecule therapies that drive programmable, · sequence-specific edits to the epigenome to treat diseases with broad impact. Our therapeutics · platform is based on small molecule epigenome editors (Epitors) t ...
-
Director, Regulatory Affairs
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
-
Director Supply Chain
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
-
Senior Project Manager- Oncology
4 weeks ago
Catalyst Clinical Research, LLC Boston, United StatesAs a Senior Project Manager - Oncology, you will be responsible for the routine cross-functional operations of assigned studies for one or more clients or management of a portfolio of functional projects, with minimal or no supervision. You will act as the team leader, ensuring t ...
-
Associate Director Clinical Trial Management
3 weeks ago
Bicara Therapeutics Boston, United StatesRole Overview · The Associate Director - Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The positi ...
-
QLD Biotherapeutics Inc Boston, United StatesFunction: Research & Development · Job Title: Sr. Research Associate/Associate Scientist, iPSC-differentiation · Job Location: Boston · At QLD Biotherapeutics, we develop cell and gene therapies using innovative technologies to treat devastating diseases. We are seeking a highly ...
-
Discovery Biology Senior Research Associate
2 weeks ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · Position Summary: · Vertex seeks a talented scientist to join the Vertex Cell and Genetic Therapies (VCGT) Cell therapy and Immunology team at The Jeffrey Leiden Center for Cell and Genetic Therapies in Boston, MA. The team's mission is to discover and actualize ...
-
Director of Quality Assurance
3 weeks ago
Walker Cole International Boston, United StatesWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. · As the Director of Quality Assurance, you will be responsible for: · Leadership of entire QA function including ...
-
Stem Cell Senior Research Associate, Gene Editing
22 hours ago
Vertex Pharmaceuticals Boston, United StatesVertex is seeking an experienced Senior Research Associate to join the Cell and Genetic Therapies (CGT) type 1 diabetes genetic engineering team in Boston, MA. The group is dedicated to discovering and advancing the next generation of cell therapies Research Associate, Senior, As ...
-
Head of Clinical Operations
2 weeks ago
Ensoma, Inc. Boston, United StatesPosition: Head of Clinical Operations Location: Boston, MA · Job Id: C0001 # of Openings: 1 · We are seeking an experienced, collaborative, and motivated individual to serve as Head of Clinical Operations for Ensoma's gene therapy programs. This role offers an opportunity for a v ...
-
Magnet Biomedicine Boston, United StatesPrincipal Research Associate/Associate Scientist, Cell Biology · About Magnet Biomedicine · Magnet Biomedicine is a fast-paced, collaborative, venture-backed startup developing rational approaches to molecular glue discovery. Magnet's TrueGlueTM Discovery Platform enables the dis ...
-
Director of Quality Assurance
3 weeks ago
Walker Cole International Boston, United StatesWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. · Ready to make your application Please do read through the description at least once before clicking on Apply. ...
-
Director of Nursing
2 weeks ago
Boston Childrens Hospital Boston, United StatesJob Posting Description · The Nursing Director for Inpatient Stem Cell Transplant will be responsible to:Provide 24-hour supervision of daily clinical and administrative operations for our 14 bed Inpatient Stem Cell Transplant (SCT) unit, treating infants to young adults undergoi ...
-
Director, Regulatory CMC, Cell
2 weeks ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory g ...
-
Associate Scientist
2 weeks ago
Lonza, Inc. Boston, United StatesToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exc ...
Executive Director, Global Program Team Leader Cell Therapy - Boston, United States - Alexion Pharmaceuticals, Inc.
Description
This is what you will do:
Reporting to the TA Head, the ED, GPTL is responsible for providing strategic direction and leading the global drug development with one or more assets that have multiple indications in development.
As the accountable program(s) owner, the GPTL, leads and chairs the Global Project Team (GPT), which determines the overall strategy for the asset across indications.
The GPTL is the "one voice" for the GPT up the line (R&D Leadership, Development Steering Committee and Executive Steering Committee).
The GPT role is one of leadership, being proactive and interactive, and emphasising partnership with all GPT members and Project Subteams, functional heads and consultants both within and outside R&D.
The GPTL should stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with the GPT.
The GPTL has the negotiation and persuasion skills necessary to ensure the program's success and sets goals for the GDT and specific program-related goals for the Core Team members.
You will be responsible for:
The GPTL is accountable for:
We would prefer for you to have:
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 believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
&v=024){kind=logo}
