Sr. Medical Director, Clinical Development (CNS/GDNF)
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Job Description
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:
Advance innovative science by pushing boundaries.
Bring transformative therapeutics to patients in need.
Provide an environment for employees to reach their fullest potential.
Our values:
Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
Position Summary
The Senior Medical Director, Clinical Development (CNS), reporting to the Vice President, GDNF Clinical Development, will be the global clinical leader responsible for one or more clinical studies across indications, involving one or multiple investigational products. Serving as a core member of the study teams, this role is responsible for unblinded medical monitoring of the safety signal associated with the study procedurals and the investigational products, working closely with the study sites/ Investigators, pharmacovigilance, blinded medical monitors at Askbio, delivery team, and the medical team at CROs, leading DSMB workstream and be responsible for patient’s safety. This position will be accountable for the study design, medical oversight of clinical trial execution, and reporting of a clinical development program(s) to support internal governance decisions and global regulatory submissions.
This position will be hybrid with a preferred geographic location near one of our offices in RTP (AskBio HQ), NC Philadelphia PA, Columbus OH, Boston MA, or Whippany NJ.
Candidate must be willing to travel approximately 30-40%
Job Responsibilities
- Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other study/program documents (specifically overall safety insights pertaining to the unblinded study data)
- Participates in cross-functional teams (blinded and un-blinded teams), along with Clinical Operations, to ensure seamless transition of study participants from neurology to neurosurgery sites, provides oversight of study safety, subjects follow -up, and overall timelines for key deliverables
- Monitoring overall study integrity and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the product and intervention (specifically overall safety insights pertaining to the unblinded study data)
- Responsible for the proactive monitoring of clinical trial safety which is conducted in collaboration with the Safety team. Evaluates all safety data generated in clinical trials and responds to (unblinded) safety questions from investigator sites and IRBs regarding safety issues and queries. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations
- Generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy
Minimum Requirements
- MD or MD equivalent (e.g., MD, MBBS, DO)
- 12+ years’ relevant industry and clinical experience
- Hands-on experience in designing (protocols), operationalizing (trial monitoring), reporting (CSRs) clinical trials, and interacting with regulatory agencies with in-depth understanding of the regulatory framework
- A minimum of 3 years years in an innovative medicine setting
- Strong clinical research background, particularly in CNS and neurodegenerative indications
- Training, patient care or drug development experience in neurology
- A minimum of 3 years of medical director level in clinical development (including phase 2-3 clinical trials) and medical monitor experience
- Hands-on drug development/clinical development in neurological indications
- Must possess excellent oral and written English communication skills
Preferred Education, Experience and Skills
- Prefer experience in gene and cell therapy
- Prefer experience in neurology, with strong preference for movement disorders expertise
- Experience with reviewing neuroimaging, comfortable with neurocritical care, familiar with neurosurgical procedures for movement disorders
- Prefer regulatory submission experience (BLA, NDA etc.)
- Sound medical judgment and experience in medical safety interpretation of safety findings for clinical trials
- Strong cross matrix team leadership skills, ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds
- Advanced analytical skills, strategic thinking and study activity planning
- Be responsive and engage in a remote/hybrid working environment, strong working ethics
AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at talent@askbio.com.