We are currently seeking an experienced MD with drug development experience and expertise in neurology or neuromuscular disease to join our team and provide clinical leadership to our development programs in neuromuscular diseases. The Director/Senior Director will report to the EVP of Research and Development. This role will be chartered to provide medical guidance and leadership to all aspects of product development including clinical advisory board management, protocol design, relationships with clinical investigators, data interpretation and reporting, manuscripts, and regulatory documents. Importantly, the individual will contribute to the successful conduct, integrity, and safety of patients in our clinical trials. He/she will play a pivotal role in late stage clinical programs in ALS and other neuromuscular diseases. The position is also expected to contribute across the continuum of clinical development, from IND stage to NDA submission.
-Serves as the primary source of medical expertise for clinical project teams and provides leadership, direction and mentoring to other staff in clinical research, biometrics, and clinical operations.
-Provides input to decisions that have medical, scientific, and future marketing implications.
-Responsible for the medical input to design, planning, initiation and completion of clinical trials.
-Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions.
-Responsible for establishing relationships with prominent clinical investigators in neuromuscular diseases.
-Represent the Company at scientific meetings to maintain an awareness of relevant scientific and clinical developments in the neuromuscular field, competitive intelligence with regards to therapeutic, and to represents Company at such associated functions such as investigator meetings or advisory boards.
-Prepare for and represent the Company during interactions with regulatory bodies, such as FDA and EMA, health technology assessment groups, and with key opinion leaders.
-Performs product safety medical reviews for assigned investigational drugs.
-Collaborate with regulatory, quality assurance, safety, clinical operations, and biometrics to ensure the timely execution of high quality clinical studies that are compliant with the current state of the art and meet the expectations of regulatory and ethical bodies.
-Reports on a regular basis to senior management.
-MD degree with board certification in neurology medicine with minimum of 8 years in clinical development experience in a biotechnology or pharmaceutical company.
-Sub-specialty training and prior industry experience in the clinical development of neuromuscular therapeutics is required; experience with studies in ALS or SMA is a strong plus.
-Knowledge of CDER regulations/ICH.
-Understanding of pharmaceutical safety reporting and surveillance requirements.
-Excellent verbal and written communication skills and presentation skills.
-Strong leadership and interpersonal skills.
-Desire to work within a multidisciplinary team.
-Ability to work internationally.