Sr. Director, Clinical Operations, Therapeutics

3 weeks ago

Cambridge, United States Moderna Full time

The 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 collaboratively across the therapeutics portfolio and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position will be responsible for initiating and leading clinical programs across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. Additionally, this position will be responsible for management of clinical operations staff which includes but is not limited to talent management, hiring, management and organization of clinical operations teams assigned to programs and studies. This position reports to the VP, Clinical Operations. Here’s What You’ll Do: Serve as a Clinical Operations Portfolio Lead across the Therapeutics, overseeing several programs and the clinical operations team(s) assigned to those programs. These programs may span therapeutic areas such as rare disease, autoimmune, cardiovascular, and other emerging disease areas within Therapeutics. This position will focus on rare disease.

Accountable for delivery of programs and studies within the assigned portfolio.

Oversee clinical operations teams and provide direction, oversight and mentorship to ensure the development of operational strategy and plans in support of execution of the Clinical Development Plan.

Partner and collaborate with cross-functional stakeholders as well as senior leaders at the therapeutic and functional line head level (eg. VP of clinical development, function line heads) to ensure clinical operations effectiveness.

Oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs. May serve as the program clinical operations lead (PCOL) for programs in early development until assignment of additional clinical operations resources.

Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations.

Responsible for budget management for assigned programs/portfolio including ensuring proactive management of all finance activities including but not limited to periodic budget reviews, CRO budget oversight and internal processes related to forecasting at the program and study level.

Responsible for representing Clinical Operations as a senior leader on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.

Support and supervise the selection, oversight, and management of CROs and other vendors.

Perform and document study level Sponsor Oversight of outsourced clinical activities as assigned/applicable.

Oversee program/study team conduct of site

feasibility/capability

assessments in collaboration with the CRO and cross-functional team.

Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.

Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders.

Communicate and present to senior leaders on issues, strategies to align, manage and solve issues that arise within the assigned portfolio (program, timelines, budget, other issues as applicable).

Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.

Maintain oversight and participate in the

creation/review/training/maintenance

of departmental and organizational SOPs to ensure compliance.

Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives.

Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna.

Manage clinical operations staff across program and study roles which includes but is not limited to talent management, hiring, management and organization of clinical operations teams assigned to programs and studies.

Strive for continuous improvement and more efficient ways of working in clinical development.

Act as a role model for Moderna’s values.

Here’s What You’ll Bring to the Table: Minimum of BA/BS with at least 12 years of trial and clinical program experience, including 8+ years of high complexity independent, global trial management experience and 4+ years of program-level management Advanced degree preferred.

Experience in complex disease areas (e.g., rare disease, autoimmune, cardiovascular and oncology). Rare disease experience required.

Robust experience in early and late phase drug development

Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.

Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

Experience in GCP inspections/audits

Outstanding verbal and written communication skills, in addition to excellent organizational skills

Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

Resilient, Creative, capable problem-solver

Excellent organizational skills and ability to work independently

Experience in establishing and maintaining relationships with key opinion leaders

Some travel required

#J-18808-Ljbffr

  • Director, Clinical Operations

    3 weeks ago

    Cambridge, United States Foghorn Therapeutics Inc. Full time

    Our Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...

  • Director, Clinical Operations

    6 days ago

    Cambridge, United States Foghorn Therapeutics Full time

    Job DescriptionJob DescriptionOur Culture: Why work with us?At Foghorn Therapeutics, we believe in “People First, Mission Always.” We put “People First” because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics...

  • Associate Director, Clinical Business Operations

    2 days ago

    Cambridge, United States Relay Therapeutics Full time

    **The Opportunity**: As the Assoc. Director, Clinical Business Operations, you will play a pivotal role in enabling the success of Relay Tx's clinical programs. You will partner with the cross-functional team members and leadership in Clinical Development, Finance, and Legal to assess the best fit for Relay Tx's growing pipeline as you lead the development...

  • Sr Director/Director, Alliance Management

    2 weeks ago

    Cambridge, Massachusetts, United States Fulcrum Therapeutics Full time

    Company Overview Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and...

  • Future Opportunities at Omega Therapeutics

    1 month ago

    Cambridge, United States Omega Therapeutics Full time

    About Omega Therapeutics:Omega Therapeutics is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines to treat or cure a broad range of diseases. By pre-transcriptionally modulating gene expression, Omega’s approach enables precision epigenomic control of nearly all human genes, including...

  • Future Opportunities at Omega Therapeutics

    3 weeks ago

    Cambridge, United States Omega Therapeutics Full time

    About Omega Therapeutics:Omega Therapeutics is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines to treat or cure a broad range of diseases. By pre-transcriptionally modulating gene expression, Omega’s approach enables precision epigenomic control of nearly all human genes, including...

  • Future Opportunities at Omega Therapeutics

    3 weeks ago

    Cambridge, United States Omega Therapeutics Full time

    Job DescriptionJob DescriptionAbout Omega Therapeutics:Omega Therapeutics is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines to treat or cure a broad range of diseases. By pre-transcriptionally modulating gene expression, Omega’s approach enables precision epigenomic control of...

  • Director, Quality Operations

    3 days ago

    Cambridge, United States Sarepta Therapeutics Full time

    The Director will be responsible for the program level QA oversight of clinical studies. This position will be a core member of the Clinical Trial team and provide Clinical Trial team support and promote collaboration to ensure all clinical trial activities and outcomes are compliant with FDA Regulations, ICH guidelines, and applicable international...

  • Director, Clinical Science

    7 days ago

    Cambridge, United States Foghorn Therapeutics Full time

    Job DescriptionJob DescriptionOur Culture: Why work with us?At Foghorn Therapeutics, we believe in “People First, Mission Always.” We put “People First” because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics...

  • Medical Director, Clinical Development

    3 weeks ago

    Cambridge, United States Beam Therapeutics Inc. Full time

    Position Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...

  • Medical Director, Clinical Development

    2 weeks ago

    Cambridge, United States Beam Therapeutics Inc. Full time

    Position Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...

  • Director, Clinical Science

    3 weeks ago

    Cambridge, United States Foghorn Therapeutics Inc. Full time

    Our Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...

  • Associate Director/Director, CMC Program Leadership

    4 weeks ago

    Cambridge, United States MOMA Therapeutics Full time

    MOMA Therapeutics is looking for an experienced Associate Director/Director, CMC Program LeadershipImagine joining a company where you.... Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates Will work with incredible humans who are committed to the discovery of transformative...

  • Associate Director, Clinical Operations

    3 weeks ago

    Cambridge, United States Clinical Dynamix, Inc. Full time

    Role: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...

  • Associate Director, People Operations

    2 weeks ago

    Cambridge, United States Obsidian Therapeutics Full time

    Associate Director, People Operations Cambridge, MA About Us… Obsidian Therapeutics is expanding the reach of TIL therapy.  We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE® platform technology to...

  • Director, Senior Director Genome Engineering

    1 month ago

    Cambridge, United States Voyager Therapeutics Full time

    About Voyager Therapeutics Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple...

  • Sr. Scientist

    1 month ago

    Cambridge, Massachusetts, United States MOMA Therapeutics Full time

    MOMA Therapeutics is looking for an experienced Sr. Scientist/Principal Scientist, Computational ChemistryUnlocking a new target class in drug discovery is no small task: it requires computation to transform data into insights; it requires scientific and technological excellence; it demands a culture of focus, resilience, creativity, and collaboration; and...

  • Director, Clinical Operations

    3 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Associate Director or Director Medical Affairs

    2 days ago

    Cambridge, United States Beacon Therapeutics (USA) Inc Full time

    Job DescriptionJob DescriptionAre you a driven Medical Affairs Leader seeking a new challenge in a fully remote position? Beacon Therapeutics invites you to apply for the Associate Director or Director Medical Affairs role. Here, you can showcase your expertise and drive key initiatives. Competitive pay aligns with industry standards, promising recognition...

  • Director, Clinical Operations

    3 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...