Senior Medical Director, Clinical Development Psychiatry (BPD)

About the role

We are seeking a Senior Medical Director, Clinical Development Psychiatry (BPD) to join our team. This incumbent is a key contributor to clinical development of the Company’s portfolio of products and product candidates from Discovery to Phase 3 and post-approval activities, focusing on leadership of clinical studies and programs as required, medical leadership, medical and safety monitoring (as Medical Monitor) for assigned company’s products.

Responsibilities

• Lead and manage clinical development studies in psychiatry, including design and medical oversight throughout clinical development stages in collaboration with internal colleagues.
• Ability to serve as medical monitor (MM) and interact collaboratively, collegially and competently with clinical research sites and investigators globally, to represent the Company, Product and protocol in the most optimal manner.
• Contribute to the preparation and on-going revisions and strategy of Clinical Development Plans for assigned products and product candidates, collaborating with other key internal functions including Translational Drug Development, Biostatistics, Clinical Operations, Regulatory, Medical Affairs and Commercial.
• Provide strategic and scientific leadership for trial designs, both standard and novel for both large and rare disease indications.
• Review scientific literature and develop product and indication knowledge to understand and effectively communicate information relating to products, product candidates and therapeutic areas.
• Serve as therapeutic area expert to provide scientific input into the development, execution, and communication of clinical trial(s).
• Maintain a high degree of awareness of the external research and regulatory environments and track emerging study data to ensure appropriateness of clinical development plans and trial endpoints.
• In collaboration with internal colleagues, identify and build relationships with KOLs and other experts to gain scientific and medical input on a variety of topics related to clinical development.
• Draft and/or review clinical and scientific sections of regulatory submissions, including INDs and NDAs, and discussion documents for interactions with regulatory and Health Authorities.
• Draft and review documents (including Investigator Brochures, clinical study protocols, and clinical study reports and regulatory submissions), as well as scientific publications (incl posters, abstracts, and manuscripts).
• Participate in the review and interpretation of clinical trial data and provide insight into the clinical relevance of trial results.
• Support in-licensing and out-licensing activities and partner relationships as needed.
• Present proposals and plans to variety of audiences, including to the Company’s Senior Executive Team.
• Contribute to the development of short- and long-term goals for the department in accordance with overall Company and Development strategies.
• Participate in the planning and management of budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Actively collaborate with external clinical and other vendors on medical, scientific, psychometric data quality expectations, reviews and actions to ensure high quality and high integrity data generation.
• Domestic and international travel may be required in the course of regular business activities.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.

Qualifications

• MD or MD/PhD with strong and versatile clinical development experience, ideally in psychiatry, preferably BPD.
• Experience in neurology disorders is an asset.
• Minimum 8-12 years progressive development experience in the pharmaceutical or industry required (e.g., regulatory agency, academic research etc.).
• Majority of relevant experience is obtained in the industry setting.
• Minimum 12+ years of relevant management experience or combination of degrees and experience.
• This equates to an MD with 6+ years of relevant management experience required.
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
• Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials: experience with clinical trials from concept to clinical study report is required.
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
• Growth mindset, leadership experience and leadership potential as a clinical development expert and Medical Monitor in a complex matrix environment.
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
• Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path.