Required Medical Director/Senior Medical Director, Clinical Development.
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
Acts as liaison between Clinical Development and other internal groups at company (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
Develop and execute life-cycle management plan, lead data generation activities such as medical affairs studies to unmet medical needs and data gaps
Support Medical Affairs: Working with field medical, Scientific Communication and Publication, Medical Information and Communication teams and provide support including reactive material development to address external stakeholder questions
Help identify and effectively interact with thought leaders to engage in scientific and medical exchange as well as understand unmet medical needs and data gaps.
Support IST Program.
Partner with pharmacovigilance to assess the safety profile of compounds.
Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholder.
Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards.
May participate in or lead clinical development contributions to due diligence or other business development activity
As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies.
Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
Present at scientific, medical and regulatory meetings globally
Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOLs, and patient advocacy groups.
Contribute to activities in support of the companys planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents.
Requirements:
MD, DO or equivalent ex-US medical degree.
5-10 years clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies;
Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s)
Excellent oral and written communication skills
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate