Senior Medical Director, Clinical Development

Xenon Careers • Boston, MA

89d • $318,500 - $352,200

About The Position

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.

Requirements

• MD or MD/PhD with strong and versatile clinical development experience, ideally in psychiatry, preferably MDD.
• Minimum 8-12 years progressive development experience in the pharmaceutical or industry required.
• Minimum 12+ years of relevant management experience or combination of degrees and experience.
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
• Experience with developing study concepts for clinical development and clinical trial designs.
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines.
• Growth mindset, leadership experience and leadership potential as a clinical development expert.
• Ability to effectively present ideas and document complex medical/clinical concepts.
• Strong interpersonal skills and problem-solving abilities.

Nice To Haves

• Experience in neurology disorders is an asset.

Responsibilities

• Lead and manage clinical development studies in psychiatry, including design and medical oversight throughout clinical development stages in collaboration with internal colleagues.
• Serve as medical monitor (MM) and interact collaboratively, collegially and competently with clinical research sites and investigators globally.
• Contribute to the preparation and on-going revisions and strategy of Clinical Development Plans for assigned products and product candidates.
• 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.
• Identify and build relationships with KOLs and other experts to gain scientific and medical input.
• Draft and/or review clinical and scientific sections of regulatory submissions, including INDs and NDAs.
• Draft and review documents including Investigator Brochures, clinical study protocols, and clinical study reports.
• 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.
• 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.
• Participate in the planning and management of budget proposals and approved budgets.
• 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.
• Plan and manage budget proposals and approved budgets.
• Recruit, lead, direct, develop, coach, and evaluate direct reports, if any.
• Act in accordance with Company policies and ensure policies are understood and followed by direct reports.
• Other duties as assigned.

Benefits

• Base salary range of $318,500 to $352,200 USD.
• Target bonus and stock options.
• Medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs.
• Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
• Vacation, personal days, sick days, and an end-of-year company shutdown.
• Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees