Chief Medical Officer (CMO
Role Overview
Our client is looking for a highly experienced clinical leader to join the team as Chief Medical Officer (CMO). While prior CMO experience is not essential, you must have significant expertise in clinical drug development, including successful leadership of Phase 3 programs and New Drug Application (NDA) submissions. This role will help guide the clinical strategy and expand the team as they move toward Phase 3 trials in their chosen therapy area. The CMO will also play a key role in engaging with Key Opinion Leaders (KOLs), attending and speaking at industry conferences, and supporting investor relations efforts.
Key Responsibilities
Clinical Leadership: Lead the ongoing clinical development of the key assets, ensuring seamless execution and reporting of the Phase 2b trials and driving the transition to Phase 3 for the therapy aligned program.
NDA Strategy and Execution: Lead the preparation and submission of NDAs, leveraging past experience with late-stage trials and regulatory interactions.
Medical Affairs: Shape the scientific positioning and communication strategy for the pipeline therapies, ensuring clear alignment between internal and external stakeholders. Medical stewardship to ensure the safe, effective and appropriate use of company products.
KOL Engagement and Conferences: Represent the company as a medical expert at conferences, participate in sessions, develop and lead advisory boards and further engage KOLs in neuroscience to build advocacy.
Investor Relations: Support investor meetings and fundraising activities by providing clear medical and clinical insights.
Team Leadership: Build and mentor the clinical and medical teams, promoting a collaborative, high-performing environment.
Regulatory Strategy: Work closely with regulatory affairs to ensure clinical activities meet all regulatory and compliance standards for global markets.
Cross-functional Collaboration: Partner with discovery, commercial, regulatory & CMC teams to align clinical development plans with broader business objectives.
Experience & Qualifications
Experience: 10+ years in clinical development within the biotech or pharmaceutical industry, with hands-on leadership experience in Phase 3 trials and successful NDA submissions. Experience in psychiatry, TRD, MDD, or similar therapeutic areas preferred but not required.Prior experience as a CMO is not mandatory; senior leadership roles such as Senior Director or Vice President in clinical development or medical affairs are welcome.
Leadership: Proven ability to lead and mentor teams, fostering a dynamic and innovative environment.
Medical Affairs: Strong experience in medical affairs, particularly in the scientific positioning of novel therapies.
Communication: Exceptional communication and presentation skills, with the ability to engage effectively with KOLs, regulatory authorities, and investors.
Education: MD, ideally with board certification or eligibility in psychiatry, or a related therapeutic area.
Additional Skills
Comprehensive understanding of the psychiatric treatment landscape, particularly in TRD and MDD.Strong network within the psychiatric community and familiarity with the regulatory requirements of aligned therapies.Ability to handle multiple stakeholders and manage the complexity of late-stage clinical development.
Why Join them?
Our client is an exciting biotech company at the forefront of developing new breakthrough treatments for mood disorders and addictions. As CMO, you will play a pivotal role in shaping the clinical strategy and advancing therapies that have the potential to significantly improve patient outcomes.
Our client is looking for a highly experienced clinical leader to join the team as Chief Medical Officer (CMO). While prior CMO experience is not essential, you must have significant expertise in clinical drug development, including successful leadership of Phase 3 programs and New Drug Application (NDA) submissions. This role will help guide the clinical strategy and expand the team as they move toward Phase 3 trials in their chosen therapy area. The CMO will also play a key role in engaging with Key Opinion Leaders (KOLs), attending and speaking at industry conferences, and supporting investor relations efforts.
Key Responsibilities
Clinical Leadership: Lead the ongoing clinical development of the key assets, ensuring seamless execution and reporting of the Phase 2b trials and driving the transition to Phase 3 for the therapy aligned program.
NDA Strategy and Execution: Lead the preparation and submission of NDAs, leveraging past experience with late-stage trials and regulatory interactions.
Medical Affairs: Shape the scientific positioning and communication strategy for the pipeline therapies, ensuring clear alignment between internal and external stakeholders. Medical stewardship to ensure the safe, effective and appropriate use of company products.
KOL Engagement and Conferences: Represent the company as a medical expert at conferences, participate in sessions, develop and lead advisory boards and further engage KOLs in neuroscience to build advocacy.
Investor Relations: Support investor meetings and fundraising activities by providing clear medical and clinical insights.
Team Leadership: Build and mentor the clinical and medical teams, promoting a collaborative, high-performing environment.
Regulatory Strategy: Work closely with regulatory affairs to ensure clinical activities meet all regulatory and compliance standards for global markets.
Cross-functional Collaboration: Partner with discovery, commercial, regulatory & CMC teams to align clinical development plans with broader business objectives.
Experience & Qualifications
Experience: 10+ years in clinical development within the biotech or pharmaceutical industry, with hands-on leadership experience in Phase 3 trials and successful NDA submissions. Experience in psychiatry, TRD, MDD, or similar therapeutic areas preferred but not required.Prior experience as a CMO is not mandatory; senior leadership roles such as Senior Director or Vice President in clinical development or medical affairs are welcome.
Leadership: Proven ability to lead and mentor teams, fostering a dynamic and innovative environment.
Medical Affairs: Strong experience in medical affairs, particularly in the scientific positioning of novel therapies.
Communication: Exceptional communication and presentation skills, with the ability to engage effectively with KOLs, regulatory authorities, and investors.
Education: MD, ideally with board certification or eligibility in psychiatry, or a related therapeutic area.
Additional Skills
Comprehensive understanding of the psychiatric treatment landscape, particularly in TRD and MDD.Strong network within the psychiatric community and familiarity with the regulatory requirements of aligned therapies.Ability to handle multiple stakeholders and manage the complexity of late-stage clinical development.
Why Join them?
Our client is an exciting biotech company at the forefront of developing new breakthrough treatments for mood disorders and addictions. As CMO, you will play a pivotal role in shaping the clinical strategy and advancing therapies that have the potential to significantly improve patient outcomes.
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