Senior Medical Director, Clinical Development (Psychiatry)
We are seeking a Senior Medical Director, Clinical Development 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. The Senior Medical Director, Clinical Development will have medical knowledge of psychiatry and preferably neurology, recent development advances in psychiatric therapeutics landscape, relevant drug development experience, be a collaborative, inspirational, resilient leader, have a broad strategic view of therapeutic area and be well-versed in high quality trial execution ability for highly collaborative approach to working with others across a range of Discovery, Clinical Development and Commercial functions is an expectation. The Senior Medical Director, Clinical Development will interact with all levels of internal staff as well as external stakeholders, including, but not limited to Key Opinion Leaders, Advisory Boards and Committees, and Health Authorities.
This position reports to the Vice President, Clinical Development, Psychiatry and will be located in the Boston, MA, USA location; we may consider other locations for an exceptional candidate.
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 serves 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.
• Provide analyses of development strategies and options for discovery pipeline programs, including input into Proof-of-Concept trials, biomarker approaches, new research opportunities etc.
• 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.
• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution, and communication of a global clinical trial(s).
• 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.
• Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Other duties as assigned.
QUALIFICATIONS:
• MD or MD/PhD with strong and versatile clinical development experience, ideally in psychiatry, preferably MDD. Experience in neurology disorders is an asset.
• Minimum 8-12 years progressive development experience in the pharmaceutical or industry or combined with equivalent research experiences (e.g., regulatory agency, academic research etc.) Majority of relevant experience is obtained in the industry setting.
• 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.
The base salary range for this role is $318,000 to $352,000 USD. We will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.