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Rapport Therapeutics
Boston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition
Job Source: Rapport TherapeuticsSeaport Therapeutics
Boston, MA, United States
The VP, Non–Clinical Development leads the development and execution of the toxicology profiling of Seaport's drug candidates, including risk assessment /mitigation, development of innovative toxicology strategies, and communication of plans throughout the organization to ensure cross–functional alignment. Seaport Therapeutics is a clinical–stage b
Job Source: Seaport TherapeuticsDiscover International
Boston, MA, United States
About the Company: A growing biopharmaceutical company focused on oncology, partnering with top pharmaceutical companies to develop innovative cancer treatments, is seeking a VP of Clinical Development. They have several succesful partnerships that are set to expand on positive data read outs early 2025. Position Overview: Our client is seeking
Job Source: Discover InternationalSeaport Therapeutics
Boston, MA, United States
The VP, Non-Clinical Development leads the development and execution of the toxicology profiling of Seaport’s drug candidates, including risk assessment /mitigation, development of innovative toxicology strategies, and communication of plans throughout the organization to ensure cross-functional alignment. Seaport Therapeutics is a clinical-stage
Job Source: Seaport TherapeuticsDyne Tx
Waltham, MA, United States
Our 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 modern oligonucleotide therapeutics that are designed toovercome limitati
Job Source: Dyne TxConfidential
Boston, MA, United States
Vice President, Translational Medicine About the Company Well-established biotechnology (BioTech) venture incubator & innovation foundry Industry Biotechnology Type Venture Capital Firm Founded 2000 Employees 201-500 Categories Biology Boston Pharmaceutical Industry Startups Venture Capital Biotechnology Health Care Medical Device Pharmaceutical M
Job Source: ConfidentialConfidential
Boston, MA, United States
Senior Vice President, Translational Medicine About the Company Well-established biotechnology (BioTech) venture incubator & innovation foundry Industry Biotechnology Type Venture Capital Firm Founded 2000 Employees 201-500 Categories Biology Boston Pharmaceutical Industry Startups Venture Capital Biotechnology Health Care Medical Device Pharmaceu
Job Source: ConfidentialEnsem Therapeutics
Waltham, MA, United States
ABOUT ENSEM THERAPEUTICS: ENSEM Therapeutics (“ENSEM”) is a Boston-based biopharmaceutical company focused on high value and difficult-to-drug targets in oncology to address unmet medical needs. The name ENSEM symbolizes innovations via the integration of groundbreaking Kinetic Ensem ble technologies for drug design. The Company’s mission is to di
Job Source: Ensem TherapeuticsBoston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a passion to create impactful neuromedicines, with fewer side effects, that allow patients and their families to live healthier and more fulfilling lives.
On a molecular scale, our deep understanding of the intricate relationships between receptors, their associated proteins, and their distributions in specific cell types and brain regions enables us to precisely direct medicines to the neural circuits underlying disease pathophysiology.
As the Head of Clinical Development, you will play a crucial role in shaping and executing all of our clinical strategies that drive the development of novel therapies to treat patients with CNS conditions, including epilepsy, neuropathic pain, and bipolar disorder. This position offers a unique opportunity to make a significant impact on the lives of these patients by advancing innovative treatments in areas of critical medical need, working with passionate CNS medical scientist colleagues.
Primary Responsibilities
Establish the clinical development strategy and hands-on tactical execution plans against the current and future development portfolio.
Manage effective internal and external relationships, such internally with members of the executive leadership team, regulatory affairs, clinical operations and medical affairs, and externally including regulatory agencies, partners, KOLs, and investigators.
Medical oversight of ongoing clinical trials.
Lead clinical sections of regulatory documents (IND, BLA/NDA).
Work with Regulatory Affairs to prepare for meetings with FDA and healthcare authorities.
Work with Medical Affairs to organize and prepare for advisory board meetings.
Prioritize and develop the company's current drug candidates as well as future pipeline compounds and contribute to go / no-go decisions.
Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
Actively participate in strategic planning for the clinical development organization and provide support to business development / licensing activities.
Maintain an understanding of competitors and clinical developments in relevant therapeutic areas.
Build and maintain medical advisory boards based on solid working relationships with KOLs and lead clinical investigators.
Build and lead a team, creating an environment where team members thrive and deliver outstanding results.
Requirements MD required, training in neuroscience or neurology required
Experience in Epilepsy, Bipolar Disorder or Neuropathic Pain required
15+ years of global clinical development experience leading the clinical development strategy in a biotech or pharmaceutical company VP or SVP title commensurate with relevant experience
5-10+ years experience managing teams preferred
Demonstrated ability to attract talent, lead, inspire, and grow and develop teams
Track record of innovative, strategic leadership, and flawless execution in the field of neurological and/or neuropsychiatry drug development.
Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents.
Success leading the design and execution of effective clinical development strategy.
Exceptional interpersonal, influencing, presentation, and written and verbal communication skills.
Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
Understanding of the general healthcare environment laws, regulations, and evolving market access trends and issues.
Knowledge and experience of building clinical development infrastructure as organizations grow.
This role is based in Boston with a one day a week onsite presence. East Coast based with frequent travel will be considered!
Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
CCPA disclosure notice can be found here.
Email Alert for VP/SVP, Clinical Development, CNS jobs in Boston, MA, United States
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